1. SOUTH SAN FRANCISCO, Calif., Feb. 23, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its fourth quarter and year end 2020 financial results after market close on Tuesday, March 2, 2021.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be…

    SOUTH SAN FRANCISCO, Calif., Feb. 23, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its fourth quarter and year end 2020 financial results after market close on Tuesday, March 2, 2021.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients. 

    Fostamatinib is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-191 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, Rigel has launched a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients.  

    Rigel's other clinical programs include an interleukin receptor-associated kinase (IRAK) inhibitor program and a receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program with partner Eli Lilly and Company. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Investor Relations Contact:

    Phone: 650.624.1232

    Email:

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  2. INDIANAPOLIS and SOUTH SAN FRANCISCO, Calif., Feb. 18, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

    Rigel's lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration.  Rigel also has ongoing…

    INDIANAPOLIS and SOUTH SAN FRANCISCO, Calif., Feb. 18, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. Pursuant to the collaboration, Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

    Rigel's lead RIPK1 inhibitor, R552, has completed Phase 1 clinical trials and will begin Phase 2 clinical trials in 2021 as part of the collaboration.  Rigel also has ongoing pre-clinical activities with its lead CNS penetrant RIPK1 inhibitor candidates.

    Under the terms of the agreement, Lilly will pay an upfront cash payment to Rigel of $125 million. Rigel may also be eligible to receive up to $835 million in potential development, regulatory, and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel's clinical development investment. Lilly and Rigel will co-develop R552 at specified contribution levels. Lilly will be responsible for all costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the U.S. Lilly will be solely responsible for all clinical development and commercialization of brain penetrating RIPK1 inhibitors in CNS indications.

    RIPK1 is a critical signaling protein implicated in a broad range of key inflammatory cellular processes including necroptosis, a type of regulated cell death, and cytokine production. In necroptosis, cells rupture leading to the dispersion of cell contents which can trigger an immune response and enhance inflammation. Inhibiting RIPK1 may be a new approach to treating various autoimmune, inflammatory, and neurodegenerative disorders. In pre-clinical studies, Rigel's R552 demonstrated prevention of joint and skin inflammation in a RIPK1-mediated murine model of inflammation and tissue damage.

    "At Lilly, our immunology strategy is focused on the pursuit of novel targets that have the potential to develop into best-in-class medicines for patients with autoimmune conditions," said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly. "RIPK1 inhibitors are a promising approach, and R552 is an exciting addition to our immunology pipeline. We look forward to working with Rigel to advance its clinical development."

    "We are very excited to form this strategic partnership with Lilly. This collaboration will provide significant resources and expertise to support a broad investigation in multiple disease indications with our RIPK1 inhibitors," said Raul Rodriguez, Rigel's president and CEO. "With Lilly's extensive knowledge in immune and CNS diseases, they are our ideal partner to ensure the clinical and commercial success of our RIPK1 inhibitor program."

    This transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.

    About Rigel

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. To learn more about Rigel, please visit us at www.rigel.com.

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com. C-LLY

    Rigel Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's partnership with Lilly; Rigel's ability to achieve development, regulatory and commercial milestone payments under its agreement with Lilly; and the potential indications that inhibiting RIPK1 may affect. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Lilly Forward-Looking Statement

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of a license and collaboration agreement between Lilly and Rigel, Lilly's development strategy, and potential payments to Rigel in connection with the license and collaboration, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the license and collaboration, that the license and collaboration will yield commercially successful products, or that Lilly will execute its strategy as expected. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

    Refer to:        

    Mark Taylor; ; (317) 276-5795 (Lilly Media)



    Kevin Hern; ; (317) 277-1838 (Lilly Investors)



    Rigel Investor Contact - (650) 624-1232;



    Rigel Media Contact – (508) 314-3157;

     

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

     

     

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  3. SOUTH SAN FRANCISCO, Calif., Jan. 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced it has been awarded $16.5 million by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support Rigel's ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients. Fostamatinib is marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).

    "We are grateful to receive this funding from the DOD and for their demonstrated commitment towards finding safe…

    SOUTH SAN FRANCISCO, Calif., Jan. 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced it has been awarded $16.5 million by the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support Rigel's ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients. Fostamatinib is marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).

    "We are grateful to receive this funding from the DOD and for their demonstrated commitment towards finding safe and effective treatments for COVID-19 patients," said Raul Rodriguez, Rigel's president and CEO. "These additional resources will contribute significantly to the advancement of our Phase 3 trial. Data from this trial, coupled with findings from the NIH-sponsored Phase 2 trial, which is anticipated to report topline results in April 2021, could potentially facilitate an EUA filing for a much needed therapy for hospitalized COVID-19 patients in the U.S."

    "The DOD is pleased to support this effort, since repurposing an existing FDA-approved drug product for potential application as a COVID-19 treatment saves time and cost, enabling a much more rapid response to the pandemic," said Dr. Jason Roos, the Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. "This investment should speed up identification of safe and effective treatments for this formidable pandemic."

    The Phase 3 clinical trial will evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical disease within 29 days.

    About COVID-19 & SYK Inhibition

    COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

    SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.

    Fostamatinib6 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA); an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, has Rigel launched a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8356, a proprietary molecule from its interleukin receptor-associated kinase (IRAK) inhibitor program, and a recently completed Phase 1 study of R5526, a proprietary molecule from its receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020

    2. Becker RC. COVID-19 Update: COVID-19 associated coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020. DOI: https://doi.org/10.1007/s11239-020-02134-3 

    3. Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020. DOI: https://doi.org/10.1101/2020.07.13.190140 

    4. Sung P-S and Hsieh S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Front. Immunol. 10:2867. DOI: https://doi.org/10.3389/fimmu.2019.02867 

    5. Behnen M. Immobilized Immune Complexes Induce Neutrophil Extracellular Trap Release by Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal of Immunology July 2014. DOI: https://doi.org/10.4049/jimmunol.1400478 

    6. The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's ability to receive payments under the DoD agreement, expected timing of the results of the NIH-sponsored Phase 2 trial and the potential for Rigel's Phase 3 study to facilitate a filing for an EUA. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Rigel Investor Contact: 

    Phone: 650.624.1232

    Email:

    Rigel Media Contact:

    Phone: 315-409-9783

    Email:

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., Jan. 11, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today provided a business update, including preliminary total revenue, TAVALISSE® (fostamatinib disodium hexahydrate) bottles sold for the quarter, Fast Track designation granted for warm autoimmune hemolytic anemia (wAIHA), and the company's expanding COVID-19 program. The company's president and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 14, 2020 at 10:00 am ET at the 39th Annual J.P. Morgan Virtual Healthcare Conference.

    "Rigel's accomplishments during the extraordinary global events of 2020 position the company well as we enter the new year," said Raul Rodriguez…

    SOUTH SAN FRANCISCO, Calif., Jan. 11, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today provided a business update, including preliminary total revenue, TAVALISSE® (fostamatinib disodium hexahydrate) bottles sold for the quarter, Fast Track designation granted for warm autoimmune hemolytic anemia (wAIHA), and the company's expanding COVID-19 program. The company's president and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 14, 2020 at 10:00 am ET at the 39th Annual J.P. Morgan Virtual Healthcare Conference.

    "Rigel's accomplishments during the extraordinary global events of 2020 position the company well as we enter the new year," said Raul Rodriguez, Rigel's president and CEO. "Annual sales of TAVALISSE grew by 41% compared to 2019, and its use as an earlier line treatment option for ITP is resonating with both patients and physicians. We are continuing to enroll our Phase 3 trial in wAIHA and we have received Fast Track designation from the FDA which is intended to expedite the review of a potential regulatory filing.

    "The availability of vaccines is a critical step in managing the COVID-19 pandemic, but we expect there will continue to be a significant need for therapeutics. Our Phase 3 trial in COVID-19 has launched and topline data from the National Institutes of Health Phase 2 trial is expected in April, which will provide a near-term look at the potential of fostamatinib in this disease."

    Commercial and Preliminary Financial Update

    In the fourth quarter of 2020, a total of 1,899 bottles of TAVALISSE were sold in the U.S., of which 1,725 were shipped directly to patients and clinics. While Rigel is still in the process of determining final results for the fourth quarter of 2020, the company expects to report net product sales of approximately $17.7 million, compared to $13.8 million in the same period of 2019, an increase of 28%.

    Contract revenues from collaborations for the quarter ended December 31, 2020, are expected to be approximately $697,000, which consists of $500,000 from Grifols related to an option for commercialization in additional territories and $197,000 in revenues earned from the performance of certain research and development services from Rigel's collaboration agreement with Grifols.

    For the fourth quarter 2020, Rigel expects to report total revenue of approximately $18.4 million.

    The company expects to report cash, cash equivalents and short-term investments as of December 31, 2020 of approximately $57.3 million, compared to $98.0 million as of December 31, 2019.

    The above information is preliminary, has not been audited and is subject to change upon completion of the audit of the company's financial statements as of and for the year ended December 31, 2020.

    Portfolio Update

    Phase 3 Trial in wAIHA

    The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAVALISSE for the treatment of wAIHA based on the significant medical need that exists and the product's potential in the treatment of these patients. Fast Track designation is designed to enable an expedited review process for any potential regulatory filings. Currently, the study has enrolled 64 of 90, or 71%, of the patients planned for enrollment.

    COVID-19 Program

    The Phase 2 clinical trial sponsored by NIH/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib for the treatment of COVID-19 has enrolled 44 of the 60 patients planned for enrollment. In this trial, patients are being randomized to fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1), administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course as well as in vitro biological correlatives evaluating the effects of the drug on pathways involved in the pathophysiology of COVID-19, including NETosis. Rigel anticipates topline data to be reported in April of this year.

    In addition, Rigel has launched its Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. The multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus SOC or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days with a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical disease within 29 days.

    In December, the Journal of Infectious Diseases (JID) published research from NIH which demonstrated that R406, the active metabolite of fostamatinib, was able to inhibit NETosis ex vivo in donor plasma from patients with COVID-19. NETosis is a unique type of cell death resulting in the release of neutrophil extracellular traps (NETs). NETs contribute to thromboinflammation and have been associated with mortality in COVID-19. These data provide insights for how fostamatinib may mitigate neutrophil-associated mechanisms contributing to COVID-19 immunopathogenesis.1

    Clinical Development Pipeline

    Rigel's IRAK1/4 program includes R835, an orally available, potent and selective inhibitor and the only molecule in clinical development that inhibits both IRAK1 and IRAK4. The company plans to pursue this program's potential in hematology/oncology and rare diseases, where it believes there are areas of significant unmet medical need. 

    Rigel has an extensive RIPK1 inhibitor program.  This program includes R552, an oral systemic RIPK1 inhibitor which has completed a Phase 1 study, as well as RIPK1 inhibitor candidates that cross the blood-brain barrier (CNS-penetrants). RIPK1 inhibitors have broad potential in numerous large indications. In order to fully develop these assets, Rigel intends to enter into a collaboration for this program.

    39th Annual J.P. Morgan Webcast Presentation Details

    Rigel's presentation will be webcast and is scheduled to take place Thursday, January 14 at 10:00 am ET. To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to the website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising, and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that recognize and mediate the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

    About COVID-19 & SYK Inhibition

    COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.2 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.3

    SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.

    Fostamatinib7 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA); an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, Rigel launched a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8357, a proprietary molecule from its interleukin receptor-associated kinase (IRAK) inhibitor program, and a recently completed Phase 1 study of R5527, a proprietary molecule from its receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1. Strich, J. et al. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. Journal of Infectious Disease December 24, 2020 https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa789/6046406

    2. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020

    3. Becker RC. COVID-19 Update: COVID-19 associated coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020. DOI: https://doi.org/10.1007/s11239-020-02134-3

    4. Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020. DOI: https://doi.org/10.1101/2020.07.13.190140

    5. Sung P-S and Hsieh S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Front. Immunol. 10:2867. DOI: https://doi.org/10.3389/fimmu.2019.02867

    6. Behnen M. Immobilized Immune Complexes Induce Neutrophil Extracellular Trap Release by Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal of Immunology July 2014. DOI: https://doi.org/10.4049/jimmunol.1400478

    7. The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; Rigel's ability to achieve development and commercial milestones; Rigel's expected operating results for the quarter ending and as of December 31, 2020, including net sales and cash, cash equivalents and short-term investments; expectations related to the market opportunity for fostamatinib as a COVID-19 therapeutic; Rigel's ability to enter into a  collaboration for its RIPK1 inhibitor program; and the safety, tolerability, design, timing and results of Rigel's products, product candidates and clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," intends," "expects." and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that Rigel may not be able to enter into a definitive agreement regarding its RIPK1 program on terms favorable or acceptable to Rigel, or at all; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  5. SOUTH SAN FRANCISCO, Calif., Jan. 7, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Thursday, January 14, 2021 at 10:00 a.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering…

    SOUTH SAN FRANCISCO, Calif., Jan. 7, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Thursday, January 14, 2021 at 10:00 a.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, Rigel launched a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor-associated kinase (IRAK) inhibitor program, and a recently completed Phase 1 study of R5521, a proprietary molecule from its receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for full Prescribing Information.

    1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

    Contact: David Burke

    Phone: 650.624.1232

    Email:

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-to-present-at-the-39th-annual-jp-morgan-healthcare-conference-301202534.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  6. SOUTH SAN FRANCISCO, Calif., Dec. 4, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be presented in two poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually December 5-8, 2020. The poster presentations will be made available on the event's website at https://www.hematology.org/meetings/annual-meeting on Saturday, December 5 at 7:30am PT.

    Rigel will present an analysis of long-term safety data on fostamatinib in more than 3,500 patients at various dosing regimens with immune thrombocytopenia (ITP) or rheumatoid arthritis (RA). No new safety signals nor cumulative…

    SOUTH SAN FRANCISCO, Calif., Dec. 4, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be presented in two poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually December 5-8, 2020. The poster presentations will be made available on the event's website at https://www.hematology.org/meetings/annual-meeting on Saturday, December 5 at 7:30am PT.

    Rigel will present an analysis of long-term safety data on fostamatinib in more than 3,500 patients at various dosing regimens with immune thrombocytopenia (ITP) or rheumatoid arthritis (RA). No new safety signals nor cumulative toxicity were observed with up to 62 months (5.2 years) of continuous treatment in ITP patients and up to 81 months (6.8 years) of continuous treatment in RA patients.

    An overview of Rigel's ongoing Phase 3 clinical trial of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) will also be presented. This is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary wAIHA who have failed at least one prior treatment.  This study is based on Rigel's Phase 2, open-label, multi-center study for the treatment of wAIHA. Results of that study demonstrated that 44% (11/25) of patients had markedly improved hemoglobin (Hgb) levels and adverse events were consistent with those in the fostamatinib safety database.

    Additionally, Rigel's planned Phase 3 clinical trial to evaluate the efficacy and safety of fostamatinib in adult, hospitalized COVID-19 patients was featured in an ASH abstract published in the November 26, 2020, issue of Blood. This is a multi-center, double-blind, placebo-controlled, adaptive design study with a primary endpoint that measures the proportion of subjects who progress to severe/critical disease within 29 days.

    Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The FDA has granted TAVALISSE Orphan Drug designation for the treatment of patients with warm AIHA.

    Poster Presentations

    Abstract #838

    Long-Term Safety Profile of the Oral Spleen Tyrosine Kinase Inhibitor Fostamatinib in Immune Thrombocytopenia (ITP) and Other Diseases

    Presenter: Aaron Sheppard, PhD

    Session Name: 311. Disorders of Platelet Number or Function: Poster I

    Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT

    Abstract #752

    Fostamatinib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study

    Presenting Author: Nichola Cooper, MD

    Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster I

    Date & Time: Saturday, December 5, 2020: 7:00 AM-3:30 PM PT

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); an NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, Rigel plans to launch a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients in the fourth quarter of 2020.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements 

    This release contains forward-looking statements relating to, among other things, the safety, tolerability, design, timing and results of Rigel's products, product candidates and clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  7. SOUTH SAN FRANCISCO, Calif. and PETACH TIKVA, Israel, Nov. 23, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) and Medison Pharma (Medison) today announced that Health Canada has approved the new drug submission (NDS) for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.

    "This approval of TAVALISSE provides ITP patients and physicians in Canada with a new oral treatment option, the only therapy to address the underlying platelet destruction that causes ITP," said Raul Rodriguez, Rigel's president and CEO. "With Medison as our collaborative partner, we believe TAVALISSE is well…

    SOUTH SAN FRANCISCO, Calif. and PETACH TIKVA, Israel, Nov. 23, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) and Medison Pharma (Medison) today announced that Health Canada has approved the new drug submission (NDS) for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.

    "This approval of TAVALISSE provides ITP patients and physicians in Canada with a new oral treatment option, the only therapy to address the underlying platelet destruction that causes ITP," said Raul Rodriguez, Rigel's president and CEO. "With Medison as our collaborative partner, we believe TAVALISSE is well positioned for commercial success in the Canadian market."

    In October 2019, Rigel entered into exclusive license agreements with Medison to commercialize TAVALISSE in Canada and Israel. With the approval from Health Canada, Medison intends to launch TAVALISSE in Canada in Q1 2021. In Israel, a decision on the new drug application (NDA) is anticipated during Q2 2021.  

    "Our multiregional partnership with Rigel to deliver TAVALISSE in Canada and Israel is a testament to our ongoing efforts to extend the reach of highly innovative therapies to patients across international markets," said Meir Jakobsohn, founder and CEO of Medison Pharma.

    "Given our specialization in delivering cutting-edge therapeutics, TAVALISSE is a natural fit for Medison's expertise and will enable us to bring a much-needed treatment option to Canadian ITP patients," said Joe O'Neill, GM of Medison Canada.  

    Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About Medison Pharma

    Medison is one of the world's largest commercial partners of leading global biotech companies. Medison is uniquely qualified to provide the complete spectrum of integrated services for international companies looking to enter or expand their presence in international markets, focusing on Canada, Israel, and Central Eastern Europe. Medison runs a corporate venture arm with a dedicated research and evaluation team boasting deep scientific and commercial backgrounds. Medison also operates a scouting program to cater its partners and is an active investor in life science projects around drug development and digital health. For more information, visit www.medison.co.il and follow Medison on LinkedIn.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); an NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, Rigel plans to launch a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients in the fourth quarter of 2020.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, the potential future commercial success of TAVALISSE in the Canadian market, Rigel's ability to receive further payments under the Medison agreement, the timing of a launch of TAVALISSE in Canada, the timing for a decision on the NDA in Israel, and the expansion of the global opportunity for TAVALISSE through more marketing authorizations and launches. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "plans," "may," "anticipates," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib in the U.S. and Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop and, if approved, commercialize fostamatinib or any other of Rigel's product candidates; the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; our expectations with respect to regulatory submissions and approvals; our research and development expenses; protection of our intellectual property; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Medison Contact

    Maya Nix

    Corporate Communications Lead

    Phone: +972.3.925.0260

    Email:

    Rigel IR Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

     

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    SOURCE Rigel Pharmaceuticals, Inc.; Medison Pharma

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  8. SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic anemia (AIHA). The FDA agreed to Rigel's proposed durable response measure for the primary efficacy endpoint as well as the inclusion of additional secondary endpoints.  

    The Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary warm AIHA who have failed at least one prior treatment. The primary efficacy endpoint for…

    SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic anemia (AIHA). The FDA agreed to Rigel's proposed durable response measure for the primary efficacy endpoint as well as the inclusion of additional secondary endpoints.  

    The Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary warm AIHA who have failed at least one prior treatment. The primary efficacy endpoint for the trial is a durable response defined as a hemoglobin level ≥ 10 g/dl with an increase from baseline of ≥ 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy. This endpoint allows for missed visits due to the COVID-19 pandemic without impacting a durable outcome. As of November 5, the trial had enrolled 57 of the 90 patients targeted for enrollment and currently has over 90 clinical trial sites established across 22 countries.

    "Our conversations with the FDA have enabled us to finalize the primary efficacy endpoint for the only ongoing Phase 3 trial in warm AIHA, a condition for which there is no approved therapy," said Raul Rodriguez, Rigel's president and CEO. "We are over 60% of our enrollment target despite the headwinds drug development is facing due to COVID-19. We believe this progress is a result of the geographic diversity of our clinical sites, the ability of fostamatinib to be given orally, and the FDA's clinical trial guidance during the pandemic."

    Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The FDA has granted TAVALISSE Orphan Drug designation for the treatment of patients with warm AIHA.

    About AIHA

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).  

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova Health System; and a Phase 2 trial for the treatment of COVID-19 being conducted by Imperial College London. Additionally, we plan to launch a Phase 3 clinical trial of fostamatinib for the treatment of hospitalized COVID-19 patients in the fourth quarter of 2020.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's ability to complete enrollment in its phase 3 clinical trial as a treatment for AIHA and the trial design for such indication. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib in the U.S. and Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop and, if approved, commercialize fostamatinib or any other of Rigel's product candidates; the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; our expectations with respect to regulatory submissions and approvals; our research and development expenses; protection of our intellectual property; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Rigel IR Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  9. SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:00 p.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering…

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:00 p.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova® Health System; and a Phase 2 trial for the treatment of COVID-19 pneumonia being conducted by Imperial College London.  

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.  

    Please see www.TAVALISSE.com for the full Prescribing Information. 

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 

    Contact: David Burke

    Phone: 650.624.1232

    Email:

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  10. SOUTH SAN FRANCISCO, Calif., Nov. 5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the third quarter ended September 30, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "Our team has done an excellent job advancing our key value drivers while adapting to the widespread changes in the current global environment," said Raul Rodriguez, Rigel's president and CEO. "We have continued to grow our TAVALISSE franchise with third quarter sales increasing 39% year-over-year and our global Phase 3 clinical trial for warm AIHA having enrolled…

    SOUTH SAN FRANCISCO, Calif., Nov. 5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the third quarter ended September 30, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "Our team has done an excellent job advancing our key value drivers while adapting to the widespread changes in the current global environment," said Raul Rodriguez, Rigel's president and CEO. "We have continued to grow our TAVALISSE franchise with third quarter sales increasing 39% year-over-year and our global Phase 3 clinical trial for warm AIHA having enrolled over 60% of our patient goal. Additionally, exploration of fostamatinib's potential in COVID-19 is rapidly expanding with our Phase 3 clinical trial launching this quarter and enrollment ongoing in the Phase 2 trials sponsored by the NIH/NHLBI and Imperial College London."

    Business Update

    Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (AIHA), has enrolled 57 of the 90 patients targeted for enrollment. The trial currently has over 90 clinical trial sites established across 22 countries.

    Rigel plans to launch a Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe/critical disease within 29 days.

    The Phase 2 clinical trial sponsored by the NIH/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients has enrolled 9 patients. This multi-center, double-blind, placebo-controlled study will randomly assign fostamatinib plus SOC or matched placebo plus SOC (1:1) to approximately 60 evaluable patients. Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29. The trial also includes multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course.

    The Imperial College London-sponsored Phase 2 clinical trial to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia has begun enrolling patients. The study is a two-stage, open label, controlled clinical trial with patients randomized (1:1:1) to fostamatinib plus SOC, ruxolitinib plus SOC, or SOC. Treatment will be administered twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose. The primary endpoint of this study is progression from mild to severe COVID-19 pneumonia within 14 days in hospitalized patients.

    Rigel recently launched FORTE, an observational study to further evaluate TAVALISSE as a second-line treatment for adult chronic ITP. The study goal is to generate additional data on patient quality of life and financial expenditures relative to the healthcare of ITP patients. Along with the post-hoc data analysis of its Phase 3 clinical program, Rigel plans to use this study to further increase and enhance its database of TAVALISSE in early line treatment of adult chronic ITP patients.

    Financial Update

    For the third quarter of 2020, Rigel reported a net loss of $14.2 million, or $0.08 per share, compared to a net loss of $11.5 million, $0.07 per share, in the same period of 2019.

    In the third quarter of 2020, total revenues were $18.4 million, consisting of $16.3 million in net product sales and $2.1 million in contract revenues from collaborations for the achievement of a milestone in accordance with the amended license and collaboration agreement with Daiichi-Sankyo. Net product sales increased by 39% from $11.7 million in the third quarter of 2019. The decrease in contract revenues from collaborations in the third quarter of 2020 from $9.1 million in the same period of 2019 was due to developmental and commercial milestones from its various collaborative partners in 2019, partially offset by the milestone in the third quarter of 2020 from Daiichi-Sankyo as noted above.

    Rigel reported total costs and expenses of $32.2 million in the third quarter of 2020, compared to $32.9 million in the same period of 2019.  The decrease in total costs and expenses was primarily due to decreases to the timing of certain commercial-related activities due to the COVID-19 pandemic, partially offset by the increases in personnel-related costs and increased use of consultants.

    For the nine months ended September 30, 2020, Rigel reported a net loss of $10.5 million, or $0.06 per share, compared to a net loss of $49.7 million, or $0.30 per share, in the same period of 2019.

    Rigel reported total revenues of $90.2 million for the nine months ended September 30, 2020, compared to $43.9 million in the same period of 2019. Total revenues for the nine months ended September 30, 2020 consisted of $43.9 million in net product sales and $46.2 million in contract revenues from collaborations. The increase in contract revenues from collaborations related to revenue from the upfront fee previously received in 2019, as well as the milestone payment received from Grifols in the first quarter of 2020 upon EC approval of the MAA for fostamatinib in Europe and the $2.1 million in contract revenues for achievement of a milestone in accordance with the amended license and collaboration agreement with Daiichi-Sankyo, partially offset by the developmental and commercial milestones from its various collaborative partners in 2019.

    Total costs and expenses for the nine months ended September 30, 2020 were $100.3 million, compared to $95.6 million in the same period of 2019. The increase in total costs and expenses was primarily related to increases in research and development cost for the on-going Phase 3 trial in warm AIHA, Phase 1 trial in RIP 1 inhibitor program and Phase 1 trial in IRAK 1/4 inhibitor program, partially offset by decreases in stock-based compensation expense and various third-party costs.

    As of September 30, 2020, Rigel had cash, cash equivalents and short-term investments of $72.8 million, compared to $98.1 million as of December 31, 2019.

    Conference Call and Webcast with Slides Today at 4:30pm Eastern Time

    Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

    Participants can access the live conference call by dialing 1-800-954-0603 (domestic) or 1-415-226-5355 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. 

    About Coronavirus Disease 2019 (COVID-19) & SYK-Signaling

    COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

    Spleen tyrosine kinase (SYK) is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).  

    Fostamatinib6 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova® Health System; and a Phase 2 trial for the treatment of COVID-19 pneumonia being conducted by Imperial College London. 

    Rigel's other clinical programs include an ongoing Phase 1 study of R8356, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5526, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1.

    Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020

    2.

    Becker RC. COVID-19 Update: COVID-19 associated coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020. DOI: https://doi.org/10.1007/s11239-020-02134-3

    3.

    Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020.  DOI: https://doi.org/10.1101/2020.07.13.190140

    4.

    Sung P-S and Hsieh S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Front. Immunol. 10:2867. DOI: https://doi.org/10.3389/fimmu.2019.02867

    5.

    Behnen M. Immobilized Immune Complexes Induce Neutrophil Extracellular Trap Release by Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal of Immunology July 2014. DOI: https://doi.org/10.4049/jimmunol.1400478

    6.

    The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; the sufficiency of Rigel's supplies of TAVALISSE; the commercialization of TAVLESSE in Europe and the timing thereof; the utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA); the impact of the COVID-19 pandemic on Rigel's results and operations; Rigel's ability to complete enrollment in its phase 3 clinical trial for AIHA and as a treatment for COVID-19 related conditions and the timing thereof; the trial design, the potential clinical benefit of fostamatinib for the treatment of hospitalized COVID-19 patients and the role of SYK inhibition in potentially improving outcomes of critically ill COVID-19 patients, including by alleviating organ dysfunction in critically ill patients with COVID-19; Rigel's ability to further develop its clinical stage products; the scientific rationale for exploring use of fostamatinib to treat COVID-19 and related conditions; Rigel's plans to support Imperial College London's IST; the potential clinical benefit of fostamatinib in COVID-19 patients and the prevention of ARDS; role of SYK inhibition in potentially improving outcomes in COVID-19 patients; and Rigel's partnering efforts.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)





    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)





































    Three Months Ended September 30,



    Nine Months Ended September 30,







    2020

    2019



    2020

    2019







    (unaudited)



    (unaudited)



















    Revenues:















    Product sales, net

    $               16,289

    $               11,716



    $               43,943

    $               29,943





    Contract revenues from collaborations 

    2,100

    9,141



    46,228

    13,945





    Total revenues

    18,389

    20,857



    90,171

    43,888



















    Costs and expenses:















    Cost of product sales

    140

    310



    574

    728





    Research and development (see Note A)  

    14,600

    14,463



    44,963

    38,638





    Selling, general and administrative (see Note A)

    17,430

    18,121



    54,780

    56,276





         Total costs and expenses

    32,170

    32,894



    100,317

    95,642



    Loss from operations 

    (13,781)

    (12,037)



    (10,146)

    (51,754)



    Interest income 

    36

    555



    563

    2,068



    Interest expense

    (429)

    (8)



    (924)

    (8)



    Net loss

    $             (14,174)

    $             (11,490)



    $             (10,507)

    $             (49,694)



















    Net loss per share, basic and diluted

    $                 (0.08)

    $                 (0.07)



    $                 (0.06)

    $                 (0.30)



















    Weighted average shares used in computing net loss per share, basic and diluted

    168,932

    167,609



    168,658

    167,326



































    Note A





























    Stock-based compensation expense included in:















    Selling, general and administrative

    $                 1,352

    $                 1,611



    $                 3,981

    $                 5,519





    Research and development

    532

    487



    1,684

    2,185







    $                 1,884

    $                 2,098



    $                 5,665

    $                 7,704





































    SUMMARY BALANCE SHEET DATA











    (in thousands)





























    September 30,

    December 31,













    2020

    2019 (1)













     (unaudited) 













    Cash, cash equivalents and short-term investments 

    $               72,812

    $               98,078











    Total assets 

    123,058

    147,569











    Stockholders' equity

    50,955

    53,815

























    (1)

    Derived from audited financial statements

     

     

     

     

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  11. SOUTH SAN FRANCISCO, Calif., Oct. 29, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its third quarter 2020 financial results after market close on Thursday, November 5, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing 1-800-954-0603 (domestic) or 1-415-226-5355 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived…

    SOUTH SAN FRANCISCO, Calif., Oct. 29, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its third quarter 2020 financial results after market close on Thursday, November 5, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing 1-800-954-0603 (domestic) or 1-415-226-5355 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).

    Fostamatinib1 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova® Health System; and a Phase 2 trial for the treatment of COVID-19 pneumonia being conducted by Imperial College London.

    Rigel's other clinical programs include an ongoing Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-announces-conference-call-and-webcast-to-report-third-quarter-2020-financial-results-and-business-update-301162491.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  12. SOUTH SAN FRANCISCO, Calif., Oct. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced enrollment of the first patients in a multicenter, Phase 2 trial to evaluate the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova® Health System. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    "As mortality continues to rise, it is evident that new therapeutics…

    SOUTH SAN FRANCISCO, Calif., Oct. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced enrollment of the first patients in a multicenter, Phase 2 trial to evaluate the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova® Health System. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    "As mortality continues to rise, it is evident that new therapeutics selectively targeting immune response are desperately needed to treat patients infected with SARS-CoV-2," stated Dr. Richard Childs, M.D., clinical director of the NHLBI. "This is a rigorously-designed clinical trial, which should provide insight into the potential safety and efficacy of fostamatinib in the treatment of severely ill patients suffering from COVID-19."

    The clinical trial is being conducted at the NIH Clinical Center in Bethesda, Maryland, the nation's largest hospital devoted entirely to clinical research, and Inova Fairfax Hospital. 

    "We are very excited to be a part of this clinical trial with the NIH/NHLBI and Rigel. This study fits seamlessly within our portfolio of research options that we have within the Inova Health System to offer our COVID-19 population," said Dr. Steven Nathan M.D., medical director, Advanced Lung Disease & Lung Transplant Program, at Inova. "Research into novel compounds is a key component in finding therapeutic options for COVID-19 patients, and with the first patients enrolled, we are one step closer to understanding the potential of fostamatinib and SYK inhibition in this disease."

    This is a randomized, double-blind, placebo-controlled trial to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients. The study will randomly assign fostamatinib or matched placebo (1:1) to approximately 60 evaluable patients who are a 5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen via nasal canula or non-invasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary objective of this study is to evaluate the safety of fostamatinib compared to placebo for the treatment of hospitalized COVID-19 patients. The secondary objective will be to assess the early efficacy and clinically relevant measures of disease progression.

    COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

    SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).

    Fostamatinib6 is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of hospitalized COVID-19 patients, in collaboration with Inova® Health System; and a Phase 2 trial for the treatment of COVID-19 pneumonia being conducted by Imperial College London.

    Rigel's other clinical programs include a completed Phase 1 study of R8356, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program, and an ongoing Phase 1 study of R5526, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020 
    2. Becker RC. COVID-19 Update: COVID-19 associated coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020. DOI: https://doi.org/10.1007/s11239-020-02134-3
    3. Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020.  DOI: https://doi.org/10.1101/2020.07.13.190140
    4. Sung P-S and Hsieh S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Front. Immunol. 10:2867. DOI: https://doi.org/10.3389/fimmu.2019.02867
    5. Behnen M. Immobilized Immune Complexes Induce Neutrophil Extracellular Trap Release by Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal of Immunology July 2014. DOI: https://doi.org/10.4049/jimmunol.1400478
    6. The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's plans to support the NIH Phase 2 trial, the trial design, the potential clinical benefit of fostamatinib for the treatment of hospitalized COVID-19 patients and the role of SYK inhibition in potentially improving outcomes of critically ill COVID-19 patients, including by alleviating thromboinflammation. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib in the U.S. and Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop and, if approved, commercialize fostamatinib or any other of Rigel's product candidates; the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; our expectations with respect to regulatory submissions and approvals; our research and development expenses; protection of our intellectual property, market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. 

    Rigel IR Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  13. SOUTH SAN FRANCISCO, Calif., Sept. 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the start of a multicenter, Phase 2 trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova® Health System. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    "With the ongoing pandemic continuing to cause tens of thousands of new daily cases…

    SOUTH SAN FRANCISCO, Calif., Sept. 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the start of a multicenter, Phase 2 trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova® Health System. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    "With the ongoing pandemic continuing to cause tens of thousands of new daily cases of COVID-19 across the U.S., there is a critical need to not only stop the spread of the virus, but to also develop new and effective therapies to treat the infected population, including those with severe and life-threatening disease," said Richard Childs, M.D., clinical director of the NHLBI. "As we work with the broader community to identify safe and effective therapeutic options for COVID-19 patients, we are hopeful that the investigation of fostamatinib will potentially aid in the fight against this pandemic."

    The clinical trial is being conducted at the NIH Clinical Center in Bethesda, Maryland, the nation's largest hospital devoted entirely to clinical research, and Inova Fairfax Hospital. 

    "Working with Dr. Childs and his team at the NIH provides an excellent platform to further explore the potential of fostamatinib to treat and prevent conditions caused by an overactive immune system in COVID-19 patients," said Raul Rodriguez, Rigel's president and CEO. "COVID-19 infection can lead to dangerous and potentially life-threatening immune responses that can attack not only the lungs, but potentially other organs. Based on our understanding of SYK's role in the pathogenesis of the virus and fostamatinib's mechanism of action, we believe expanding our clinical effort into this second trial in COVID-19 related lung injuries is critical."

    COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

    SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    This is a randomized, double-blind, placebo-controlled trial to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients. The study will randomly assign fostamatinib or matched placebo (1:1) to approximately 60 evaluable patients who are a 5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen via nasal canula or non-invasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation). Treatment will be administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary objective of this study is to evaluate the safety of fostamatinib compared to placebo for the treatment of hospitalized COVID-19 patients. The secondary objective will be to assess the early efficacy and clinically relevant measures of disease progression.

    Recently, researchers at The Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard led a screen focused on drug repurposing to identify U.S. Food and Drug Administration (FDA) approved compounds that reduce mucin-1 (MUC1) protein abundance. MUC1 is a biomarker used to predict the development of acute lung injury and ARDS, and it correlates with poor clinical outcomes. Of the 3,713 compounds that were screened, fostamatinib was the only compound identified that both decreased expression of MUC1 and is FDA approved.6 Additionally, a recent study led by the Amsterdam University Medical Center at the University of Amsterdam, found that anti-Spike IgG from serum of severely ill COVID-19 patients induces a hyperinflammatory response by human macrophages, a response that can be counteracted by SYK inhibition with fostamatinib. This study also found that anti-Spike IgG can break down pulmonary endothelial barriers and induce microvascular thrombosis.3 Fostamatinib is currently in a Phase 2 trial being conducted by Imperial College London to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is also currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia7.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8357, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5527, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020 

    2. Becker RC. COVID-19 Update: COVID-19 associated coagulopathy. Journal of Thrombosis and Thrombolysis May 15, 2020. DOI: https://doi.org/10.1007/s11239-020-02134-3 

    3. Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020.  DOI: https://doi.org/10.1101/2020.07.13.190140 

    4. Sung P-S and Hsieh S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Front. Immunol. 10:2867. DOI: https://doi.org/10.3389/fimmu.2019.02867 

    5. Behnen M. Immobilized Immune Complexes Induce Neutrophil Extracellular Trap Release by Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal of Immunology July 2014. DOI: https://doi.org/10.4049/jimmunol.1400478 

    6. Alimova M. et al. A High Content Screen for Mucin-1-Reducing Compounds Identifies Fostamatinib as a Candidate for Rapid Repurposing for Acute Lung Injury during the COVID-19 pandemic. bioRxiv June 30, 2020.  DOI: https://doi.org/10.1101/2020.06.30.180380 

    7. The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's plans to support the NIH Phase 2 trial, the trial design, the potential clinical benefit of fostamatinib for the treatment of hospitalized COVID-19 patients and the role of SYK inhibition in potentially improving outcomes of critically ill COVID-19 patients, including by alleviating thromboinflammation. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib in the U.S. and Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop and, if approved, commercialize fostamatinib or any other of Rigel's product candidates; the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; our expectations with respect to regulatory submissions and approvals; our research and development expenses; protection of our intellectual property; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Rigel IR Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  14. SOUTH SAN FRANCISCO, Calif., Sept. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at two virtual investor conferences in September.

    Investor Presentations:
    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Tuesday, September 15, 2020
    Time: 1:00pm ET/10:00am PT

    Cantor Fitzgerald Virtual Global Healthcare Conference 2020
    Date: Wednesday, September 16, 2020
    Time: 1:20pm ET/10:20am PT

    To access these events live or the archived webcasts, go to the Investors section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate…

    SOUTH SAN FRANCISCO, Calif., Sept. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at two virtual investor conferences in September.

    Investor Presentations:

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Tuesday, September 15, 2020

    Time: 1:00pm ET/10:00am PT

    Cantor Fitzgerald Virtual Global Healthcare Conference 2020

    Date: Wednesday, September 16, 2020

    Time: 1:20pm ET/10:20am PT

    To access these events live or the archived webcasts, go to the Investors section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia1.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

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    SOURCE Rigel Pharmaceuticals, Inc.

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  15. SOUTH SAN FRANCISCO, Calif., Sept. 2, 2020 /PRNewswire/ -- Rigel Pharmaceuticals (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to participate in a panel discussion on COVID-19 during Citi's 15th Annual BioPharma Virtual Conference taking place September 9-10, 2020.

    Citi Panel Details:
    Panel Topic: State of Play for COVID-19 Therapeutics
    Date: Wednesday, September 9
    Time: 9:50 a.m. Eastern Time

    To access the event live or the archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary…

    SOUTH SAN FRANCISCO, Calif., Sept. 2, 2020 /PRNewswire/ -- Rigel Pharmaceuticals (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to participate in a panel discussion on COVID-19 during Citi's 15th Annual BioPharma Virtual Conference taking place September 9-10, 2020.

    Citi Panel Details:

    Panel Topic: State of Play for COVID-19 Therapeutics

    Date: Wednesday, September 9

    Time: 9:50 a.m. Eastern Time

    To access the event live or the archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia1.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-to-participate-in-citis-15th-annual-biopharma-virtual-conference-301122559.html

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  16. SOUTH SAN FRANCISCO, Calif., Aug. 4, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the second quarter ended June 30, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "During the second quarter we achieved significant progress across all aspects of our business, despite the challenges resulting from the COVID-19 pandemic," said Raul Rodriguez, Rigel's president and CEO. "Sales of TAVALISSE increased during the quarter and in July, the product became available in initial European markets. We continued to advance our pipeline, most…

    SOUTH SAN FRANCISCO, Calif., Aug. 4, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the second quarter ended June 30, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "During the second quarter we achieved significant progress across all aspects of our business, despite the challenges resulting from the COVID-19 pandemic," said Raul Rodriguez, Rigel's president and CEO. "Sales of TAVALISSE increased during the quarter and in July, the product became available in initial European markets. We continued to advance our pipeline, most recently with the launch of an investigator-sponsored trial in COVID-19 pneumonia. We believe there is clear scientific rationale to explore the potential of SYK-inhibition to treat these patients and possibly prevent severe respiratory conditions resulting from COVID-19. We will continue to pursue opportunities to expand these efforts."

    COVID-19 Program Highlights

    Rigel announced a Phase 2 investigator-sponsored trial (IST) with Imperial College London to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia. The IST is a two-stage, open label, controlled clinical trial with patients randomized (1:1:1) to fostamatinib, ruxolitinib, or standard of care. Treatment will be administered twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel will provide support for this trial along with Novartis.

    Recent in vitro studies led by the Amsterdam University Medical Center at the University of Amsterdam, showed that R406, the active metabolite of fostamatinib, blocked macrophage hyperinflammatory responses to a combination of immune complexes formed by anti-Spike IgG in serum from severe COVID-19 patients. Anti-Spike IgG levels are known to correlate with the severity of COVID-19. These results suggest that by inhibiting anti-Spike IgG-mediated hyperinflammation, R406 could potentially play a role in the prevention of cytokine storms as well as pulmonary edema and thrombosis associated with severe COVID-19.1

    In addition, researchers at The Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard led a recent screen to identify FDA-approved compounds that reduce mucin-1 (MUC1) protein abundance. MUC1 is a biomarker used to predict the development of ALI and ARDS and correlates with poor clinical outcomes. Of the 3,713 compounds that were screened, fostamatinib was the only compound identified which both decreased expression of MUC1 and is FDA approved. Fostamatinib demonstrated preferential depletion of MUC1 from epithelial cells without affecting cell viability. The research was focused on drug repurposing for the much lower risk of toxicity and the ability of FDA-approved treatments to be delivered on a shortened timescale, which is critical for patients afflicted with lung disease resulting from COVID-19.2

    Business Update

    Post-hoc data analysis from Rigel's previous Phase 3 clinical program of TAVALISSE in adult patients with chronic ITP, which highlights the potential benefit of use in earlier lines of therapy, was published in the British Journal of Haematology. Inclusion in one of the leading peer-reviewed journals in the field of hematology underscores the significance of the 78% (25/32) response rate, defined as at least 1 platelet count of at least 50,000/µL, when TAVALISSE was used as a second-line therapy in Rigel's Phase 3 clinical program. Adverse events were manageable and consistent with those previously reported with fostamatinib. Rigel's field teams are sharing this analysis with physicians.

    Grifols S.A., Rigel's collaborator in Europe, launched fostamatinib disodium hexahydrate in Germany and the United Kingdom in July, under the European brand name TAVLESSE. TAVLESSE is indicated in Europe for the treatment of chronic ITP in adult patients who are refractory to other treatments.

    Clinical trial sites in Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (wAIHA), are now mostly open and enrolling patients after a temporary postponement due to the COVID-19 pandemic. Currently, the FORWARD study has enrolled 44 of the 90 patients targeted for enrollment and has over 90 active clinical trial sites established across 22 countries with incremental sites being added.

    At the European League Against Rheumatism (EULAR) 2020 E-Congress in June, Rigel presented two oral and two poster presentations highlighting its investigational compound R835, a potent and selective inhibitor of both interleukin receptor associated kinase (IRAK)1 and IRAK4. In multiple pre-clinical rodent models of acute and chronic inflammation, R835 administration resulted in reduced inflammation, and in Phase 1 human studies it showed encouraging pharmacokinetic properties.

    Rigel has appointed Dave Santos as executive vice president and chief commercial officer. Mr. Santos joins Rigel with over 30 years of commercial experience in the biopharmaceutical industry with companies such as Bristol-Myers Squibb, Lilly, Genentech, and most recently Jazz Pharmaceuticals, where he led the Hematology/Oncology Business Unit. He has a robust track record in sales and marketing leadership roles, building commercial capabilities, and growing brands in the hematology-oncology area, where he has spent most of his career.

    Financial Update

    For the second quarter of 2020, Rigel reported a net loss of $17.6 million, or $0.10 per share, compared to a net loss of $20.6 million, $0.12 per share, in the same period of 2019.

    In the second quarter of 2020, total revenues were $16.0 million, consisting of $15.0 million in net product sales and $1.0 million in contract revenues from collaborations. Net product sales increased by 47% from $10.2 million in the second quarter of 2019.

    Rigel reported total costs and expenses of $33.4 million in the second quarter of 2020, compared to $31.7 million for the same period in 2019. The increase in total costs and expenses was primarily due to the increase in third-party costs related to Rigel's ongoing pivotal Phase 3 study in warm AIHA, research and development costs related to other clinical programs and personnel-related costs, partially offset by stock-based compensation expense.

    For the six months ended June 30, 2020, Rigel reported net income of $3.7 million, or $0.02 per share, compared to a net loss of $38.2 million, or $0.23 per share, in the same period of 2019.

    Rigel reported total revenues of $71.8 million for the six months ended June 30, 2020, compared to $23.0 million for the same period in 2019. Total revenues for the six months ended June 30, 2020 consisted of $27.7 million in net product sales and $44.1 million in revenues related to Rigel's collaboration agreement with Grifols. Total revenues for the six months ended June 30, 2019 consisted of $18.2 million in net product sales and $4.8 million in revenues related to Rigel's collaboration agreements with Grifols and Kissei.

    Total costs and expenses for the six months ended June 30, 2020 were $68.1 million, compared to $62.7 million, for the same period of 2019. The increase in total costs and expenses was primarily related to the research and development cost for its ongoing pivotal Phase 3 study in warm AIHA and research and development costs related to other clinical programs, partially offset by stock-based compensation expense.

    As of June 30, 2020, Rigel had cash, cash equivalents and short-term investments of $92.5 million, compared to $98.1 million as of December 31, 2019.

    Conference Call and Webcast with Slides Today at 4:30pm Eastern Time

    Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

    About Coronavirus Disease 2019 (COVID-19) & SYK-Signaling

    COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock along with endothelial dysfunction and subsequently micro and macrovascular thrombosis.3 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a dysregulated immune response and more recently a hypercoagulable state leading to immunothrombosis.4

    Spleen tyrosine kinase (SYK) is involved in the intracellular signaling pathways of many different immune cells. SYK inhibition may improve outcomes in patients with COVID-19 by biological mechanisms which include the inhibition of pro-inflammatory cytokines by monocytes and macrophages, decreased production of neutrophil extracellular traps (NETs) by neutrophils, and inhibition of platelet aggregation; three pathways that are mediated through Fc receptors (FcR) recognition of antigen-antibody complexes or activation of c-type lectin receptors (CLEC).1 In monocytes and macrophages, SYK mediates the pro-inflammatory process through the production of pro-inflammatory cytokines. The production of pro-inflammatory cytokines has been reversed with the inhibition of SYK in MERS-CoV infected macrophages.5

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia6.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8356, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5526, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1. Hoepel W. et al. Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes macrophage hyper-inflammatory responses. bioRxiv July 13, 2020.  doi: https://doi.org/10.1101/2020.07.13.190140 

    2. Alimova M. et al. A High Content Screen for Mucin-1-Reducing Compounds Identifies Fostamatinib as a Candidate for Rapid Repurposing for Acute Lung Injury during the COVID-19 pandemic. bioRxiv June 30, 2020.  doi: https://doi.org/10.1101/2020.06.30.180380 

    3. Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med 2020

    4. A.V. Rapkiewicz et al. Map-ftcm-otaaiC-Acs. EClinicalMedicine (2020). doi: https://doi.org/10.1016/j.eclinm.2020.100434 

    5. Zhao X, Chu H, Wong BH, et al. Activation of C-Type Lectin Receptor and (RIG)-I-Like Receptors Contributes to Proinflammatory Response in Middle East Respiratory Syndrome Coronavirus-Infected Macrophages. J Infect Dis 2020;221:647-59

    6. The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; the sufficiency of Rigel's supplies of TAVALISSE; the commercialization of TAVLESSE in Europe and the timing thereof; the utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA); the impact of the COVID-19 pandemic on Rigel's results and operations; Rigel's ability to complete enrollment in its phase 3 clinical trial for AIHA and the timing thereof; Rigel's ability to further develop its clinical stage products; the scientific rationale for exploring use of fostamatinib to treat COVID-19 and related conditions; Rigel's plans to support Imperial College London's IST; the potential clinical benefit of fostamatinib in COVID-19 patients and the prevention of ARDS; role of SYK inhibition in potentially improving outcomes in COVID-19 patients; and Rigel's partnering efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

































    Three Months Ended June 30,



    Six Months Ended June 30,





    2020

    2019



    2020

    2019





    (unaudited)



    (unaudited)















    Revenues:













    Product sales, net

    $        14,974

    $          10,173



    $ 27,654

    $  18,227



    Contract revenues from collaborations 

    1,047

    234



    44,128

    4,804



    Total revenues

    16,021

    10,407



    71,782

    23,031















    Costs and expenses:













    Cost of product sales

    279

    311



    434

    418



    Research and development (see Note A)  

    14,214

    13,226



    30,363

    24,175



    Selling, general and administrative (see Note A)

    18,920

    18,209



    37,350

    38,155



         Total costs and expenses

    33,413

    31,746



    68,147

    62,748

    Loss from operations 

    (17,392)

    (21,339)



    3,635

    (39,717)

    Interest income 

    169

    733



    527

    1,513

    Interest expense

    (353)



    (495)

    Net income (loss)

    $       (17,576)

    $         (20,606)



    $   3,667

    $ (38,204)















    Net income (loss) per share, basic and diluted

    $           (0.10)

    $             (0.12)



    $     0.02

    $     (0.23)















    Weighted-average shares used in computing net income (loss) per share









    Basic

    168,570

    167,191



    168,519

    167,182



    Diluted

    168,570

    167,191



    168,525

    167,182





























    Note A

























    Stock-based compensation expense included in:













    Selling, general and administrative

    $          1,299

    $            1,742



    $   2,629

    $    3,908



    Research and development

    458

    911



    1,152

    1,698





    $          1,757

    $            2,653



    $   3,781

    $    5,606































    SUMMARY BALANCE SHEET DATA









    (in thousands)

























    June 30,

    December 31,











    2020

    2019 (1)











     (unaudited) 











    Cash, cash equivalents and short-term investments 

    $        92,497

    $          98,078









    Total assets 

    138,035

    147,569









    Stockholders' equity

    63,210

    53,815











    (1)

    Derived from audited financial statements

     

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  17. SOUTH SAN FRANCISCO, Calif., July 28, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its second quarter 2020 financial results after market close on Tuesday, August 4, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com.  The webcast will be archived…

    SOUTH SAN FRANCISCO, Calif., July 28, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its second quarter 2020 financial results after market close on Tuesday, August 4, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com.  The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia1.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Contact: David Burke

    Phone: 650.624.1232

    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

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  18. SOUTH SAN FRANCISCO, Calif., July 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that a paper presenting a post-hoc data analysis of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, as well as accompanying commentary have been published in the British Journal of Haematology. TAVALISSE, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, is indicated for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "This post-hoc data analysis represents a potential paradigm shift in the treatment of adult patients with ITP following the use of a first-line treatment, predominantly steroids," stated Ralph Boccia, MD, Center for Cancer…

    SOUTH SAN FRANCISCO, Calif., July 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that a paper presenting a post-hoc data analysis of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, as well as accompanying commentary have been published in the British Journal of Haematology. TAVALISSE, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, is indicated for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "This post-hoc data analysis represents a potential paradigm shift in the treatment of adult patients with ITP following the use of a first-line treatment, predominantly steroids," stated Ralph Boccia, MD, Center for Cancer and Blood Disorders, Bethesda, Maryland and first author of the paper. "ITP is a heterogeneous disease that requires an individualized treatment approach. This data analysis offers clinicians a better understanding of the role of TAVALISSE, with its novel mechanism of action, as an alternative treatment early in the course of the disease."

    Rigel conducted the post-hoc data analysis, which has previously been presented, from a Phase 3 clinical program of TAVALISSE in adult patients with ITP. The published data analysis and accompanying commentary highlight the higher response rate and decrease in bleeding incidents in ITP patients receiving TAVALISSE as a second-line therapy. In this analysis, 32 patients received fostamatinib as a second-line therapy, of which, 78% (25/32) achieved at least 1 platelet count of at least 50,000/µL while on treatment (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.

    About ITP 

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. In addition to fostamatinib, current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About TAVALISSE 

    Indication  

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 

    Important Safety Information 

    Warnings and Precautions 

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required. 
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation. 
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE. 
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation. 
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose. 

    Drug Interactions 

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose. 
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406. 
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug. 
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug. 

    Adverse Reactions 

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%). 
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia. 

    Please see www.TAVALISSE.com for full Prescribing Information. 

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088). 

    TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc. 

    About Rigel (www.rigel.com) 

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib). Fostamatinib is currently being studied in an investigator-sponsored trial conducted by Imperial College London for the treatment of COVID-19 pneumonia1.

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.­­­­ 

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority. 

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, the potential benefit of using TAVALISSE in earlier lines of therapy, including as a second line therapy, for adult patients with ITP.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE in the U.S. and TAVLESSE in Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  19. SOUTH SAN FRANCISCO, Calif., July 14, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the initiation of an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    SYK is a key mediator of immunoreceptor signaling in a host of inflammatory cells. Studies of severe acute respiratory syndrome (SARS) and other acute viral respiratory infections suggest that the pathogenesis…

    SOUTH SAN FRANCISCO, Calif., July 14, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the initiation of an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S. and Europe as a treatment for adult chronic immune thrombocytopenia (ITP).

    SYK is a key mediator of immunoreceptor signaling in a host of inflammatory cells. Studies of severe acute respiratory syndrome (SARS) and other acute viral respiratory infections suggest that the pathogenesis relies on a series of SYK-dependent events involving activation of C-type lectin receptors (CLR) and immunoglobulin Fcg receptors (FcgR) in multiple cell types. Such SYK-mediated processes result in excessive cytokine and chemokine release, neutrophil activation associated with extensive NETosis (a highly inflammatory and thrombogenic type of cell death), and endothelial cell stimulation leading to vascular endothelium leakage and edema in the lungs. Together, these events can contribute to acute respiratory distress syndrome (ARDS), micro-thrombosis and associated systemic complications. 1,2

    The hallmark of severe COVID-19 is hypoxemia and a radiological pattern of acute lung injury (ALI) that shares features with ARDS. By inhibiting SYK, fostamatinib may specifically inhibit the infiltration and activation of monocytes and neutrophils in the lungs that are prominent in COVID-19.1,2

    "The COVID-19 global pandemic continues to extract a significant human and economic toll and there remains a serious and immediate need for safe and effective therapies," said Raul Rodriguez, Rigel's president and CEO. "Severe COVID-19 pneumonia can lead to acute respiratory distress syndrome, or ARDS, which can often be fatal. Given encouraging data from pre-clinical models of fostamatinib, we believe there is potential for SYK inhibition to help treat the severity of the disease for these patients and to prevent ARDS.

    "We are pleased to be able to support the exciting work being done by our colleagues at Imperial College London. Their efforts will be valuable as we explore fostamatinib in COVID-19 and pursue our plans for a Rigel-led study."

    The Imperial College London IST will be a two-stage open label, controlled clinical trial with patients randomized (1:1:1) to fostamatinib, ruxolitinib, or standard of care. Treatment will be administered twice daily for 14 days and patients will receive a follow-up assessment at day 14 and day 28 after the first dose. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel will provide support for this trial along with Novartis.

    In addition, researchers at The Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard led a recent screen to identify FDA-approved compounds that reduce mucin-1 (MUC1) protein abundance. MUC1 is a biomarker used to predict the development of ALI and ARDS and correlates with poor clinical outcomes. Of the 3,713 compounds that were screened, fostamatinib was the only compound identified which both decreased expression of MUC1 and is FDA approved, and so allows for rapid repurposing for patients with COVID-19 lung injury. Fostamatinib demonstrated preferential depletion of MUC1 from epithelial cells without affecting cell viability. The research was focused on drug repurposing for the much lower risk of toxicity and the ability of FDA-approved treatments to be delivered on a shortened timescale, which is critical for patients afflicted with lung disease resulting from COVID-19.3

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and is marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8354, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5524, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1Braselmann S. et al. R406, an orally available spleen tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune complex-mediated inflammation. J Pharmacol Exp Ther. 2006 Dec;319(3):998-1008. Epub 2006 Aug 31

    2Fu Y. et al. Understanding SARS-CoV-2-Mediated Inflammatory Responses: From Mechanisms to Potential Therapeutic Tools. Virologica Sinica. March 3, 2020

    3Alimova M. et al. A High Content Screen for Mucin-1-Reducing Compounds Identifies Fostamatinib as a Candidate for Rapid Repurposing for Acute Lung Injury during the COVID-19 pandemic. bioRxiv June 30, 2020.  doi: https://doi.org/10.1101/2020.06.30.180380.

    4This product candidate is investigational and has not been established safe or effective by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's plans to support Imperial College London's IST, the potential clinical benefit of fostamatinib in COVID-19 patients and the prevention of ARDS; and Rigel's plans to pursue exploration of fostamatinib in COVID-19 patients and a Rigel led study.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE in the U.S. and TAVLESSE in Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.  

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  20. SOUTH SAN FRANCISCO, Calif., July 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Grifols S.A., its collaborative partner in Europe, has launched TAVLESSE® in Germany and the United Kingdom. It was approved by the European Commission in January 2020 for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. TAVLESSE, which is marketed in the U.S. under the brand name TAVALISSE®, is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP by impeding platelet destruction.

    "The launch of TAVLESSE in Germany and the United Kingdom is an important step in making our product available to ITP patients across Europe

    SOUTH SAN FRANCISCO, Calif., July 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Grifols S.A., its collaborative partner in Europe, has launched TAVLESSE® in Germany and the United Kingdom. It was approved by the European Commission in January 2020 for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. TAVLESSE, which is marketed in the U.S. under the brand name TAVALISSE®, is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP by impeding platelet destruction.

    "The launch of TAVLESSE in Germany and the United Kingdom is an important step in making our product available to ITP patients across Europe," said Raul Rodriguez, Rigel's president and CEO. "Europe represents approximately half of the estimated $900 million ITP market outside of the U.S., and Grifols's experience with treatments for hematological disorders make them the ideal collaborative partner for our product."

    Spain-based Grifols S.A. ((MCE: GRF, MCE: GRF.P, NASDAQ:GRFS) is a global healthcare company and a leading producer of plasma-derived medicines for the treatment of rare and chronic diseases, including intravenous immunoglobulin (IVIG) which is used in the treatment of ITP.

    About ITP

    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include IVIG, steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About TAVLESSE

    Indication

    TAVLESSE® (Fostamatinib Disodium Hexahydrate) is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

    TAVLESSE Dosage

    Fostamatinib dosing requirements must be individualized based on the patient's platelet counts. The lowest dose of fostamatinib to achieve and maintain a platelet count of at least 50,000/µL should be used. Dose adjustments are based upon the platelet count response and tolerability.

    The recommended starting dose of fostamatinib is 100 mg twice daily.  After initiating fostamatinib, the dose can be increased to 150 mg twice daily after 4 weeks based on platelet count and tolerability. A daily dose of 300 mg daily must not be exceeded. Management of some adverse reactions may require dose interruption, reduction, or discontinuation.

    Discontinuation: Treatment with fostamatinib should be discontinued after 12 weeks of fostamatinib therapy if the platelet count does not increase to a level sufficient to avoid clinically important bleeding. For Monitoring and dose modifications please refer to SmPC.

    Special populations: No dose adjustment is necessary in patients with renal impairment or the elderly. Fostamatinib should not be used in patients with severe hepatic impairment or children and adolescents less than 18 years of age because of adverse reactions on actively growing bones observed in nonclinical studies.

    Administration:  Fostamatinib is for oral use. The tablets should be taken twice daily, whole with or without food. In the event of gastric upset, tablets may be taken with food.

    Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (see SmPC)

    Special warnings and precautions for use (for more information see the SmPC):  Information is based on ITP placebo-controlled population unless specified.

    Excipients:

    TAVLESSE 100 mg film-coated tablets contains 23 mg sodium per tablet, equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

    TAVLESSE 150 mg film-coated tablets contains 34 mg sodium per tablet, equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

    Hypertension

    In the ITP placebo-controlled population, increased blood pressure, including the development of hypertension, was reported in patients treated with fostamatinib. Hypertensive crisis occurred in 1 (1%) patient. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects of fostamatinib.

    The patient's blood pressure should be monitored every two weeks until stable, then monthly, and adjust or initiate antihypertensive therapy to ensure maintenance of blood pressure control during fostamatinib therapy. If increased blood pressure persists despite appropriate therapy, the physician should consider fostamatinib dose interruption, reduction or discontinuation.

    Liver function test abnormalities and risk of hepatotoxicity

    In the placebo-controlled studies, laboratory testing showed maximum ALT/AST levels more than 3 x the upper limit of normal (ULN) in 9% of patients receiving fostamatinib and no patients receiving placebo.

    Sparse data suggest an increased risk of hyperbilirubinemia in patients with genetic polymorphisms of UGT1A1, e.g. Gilbert, the physician should monitor these patients frequently.

    For all patients, transaminases recovered generally to baseline levels within 2 to 6 weeks of dose-modification. The physician should monitor liver function tests monthly during treatment. If ALT or AST increase more than 3 x ULN, the physician should manage hepatotoxicity by treatment interruption, reduction or discontinuation. Concomitant total bilirubin increases greater than 2 X ULN should lead to treatment discontinuation.

    Complete blood counts (CBCs)

    The physician should monitor CBCs, including platelet counts, monthly until a stable platelet count (of at least 50,000/µL) is achieved. Thereafter, the physician should continue to monitor CBCs, including neutrophils, regularly.

    Diarrhea

    Diarrhea is the most common adverse reaction with fostamatinib treatment, but severe diarrhea occurred in 1% of patients. Patients should be monitored for the development of diarrhea and managed by using supportive care measures (e.g., dietary changes, hydration and/or antidiarrheal medication) early after the onset of symptoms. If diarrhea becomes severe (Grade 3 or above), administration of fostamatinib should be interrupted, reduced, or discontinued.

    Neutropenia

    Neutropenia occurred in 7% of patients treated with fostamatinib; febrile neutropenia occurred in 1% of patients. Patients with neutropenia may be more susceptible to infections. The physician should monitor the absolute neutrophil count monthly. The physician should manage toxicity with fostamatinib interruption, reduction or discontinuation.

    Infections

    Infections, including pneumonia and respiratory tract infections, have been reported during clinical trials. The patient should be monitored for infection during treatment. The benefit risk of continuing therapy during an infection should be evaluated by the physician.

    Bone remodeling

    Since fostamatinib was shown in vitro to not only target SYK but also other tyrosine kinases that are involved in the bone metabolism (e.g., VEGFR, RET), any potential untargeted effects on bone remodeling or formation remain undetermined, especially in patients with osteoporosis, patients with fractures or young adults where epiphyseal fusion has not yet occurred. Closer monitoring in these patients is therefore recommended. The benefit risk of continuing therapy during the healing of a bone fracture should be thoroughly evaluated by the physician.

    (see SmPC for interactions with other medicinal products and other form of interactions)

    Women of childbearing potential must use effective contraception during treatment and at least one month after the last dose.

    Pregnancy: Based on findings from animal studies and its mechanism of action, fostamatinib can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised about the potential risk to a fetus. Pregnancies occurring during clinical trials resulted in healthy newborns as well as stillbirths/spontaneous abortions and miscarriages. If a patient becomes pregnant while taking fostamatinib, therapy should be discontinued. Fostamatinib is contraindicated during pregnancy.

    Breast-feeding: It is unknown whether fostamatinib/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of fostamatinib metabolites in milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with fostamatinib and for at least one month after the last dose.

    Fertility: There are no data on the effect of fostamatinib on human fertility. Based on the finding of reduced pregnancy rates in animal studies, fostamatinib may affect female fertility. Studies in animals have shown no adverse effect on male fertility. Given there is no evidence for mutagenic or clastogenic potential, there is no concern for male-mediated birth defects.

    Undesirable effects

    In the ITP placebo-controlled studies, serious adverse drug reactions were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which each occurred in 1% of patients receiving fostamatinib. In addition, severe adverse reactions observed in patients receiving fostamatinib included dyspnea and hypertension (both 2%); and neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope and hypoxia (all 1%).

    The most common reported adverse reactions associated with fostamatinib were: Upper respiratory tract infection, respiratory tract infection, bronchitis, lower respiratory tract infection, viral upper respiratory tract infection, Neutropenia, febrile neutropenia, Dizziness, Dysgeusia, Hypertension, Diarrhea, nausea, frequent bowel movement, upper abdominal pain, abdominal pain, rash, rash erythematous, rash macular, Chest pain, fatigue, influenza like illness, Alanine aminotransferase increased, aspartate aminotransferase increased, blood pressure (BP) increased, BP diastolic abnormal, BP diastolic increased, BP systolic increased, hepatic enzyme increased, liver function test abnormal, Neutrophil count decreased. For full details please refer to the SmPC.

    Reporting of suspected adverse reactions

    Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V (refer to SmPC).

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1This product candidate is investigational and has not been established safe or effective by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements relating to, among other things, Rigel's plans to make TAVLESSE available to ITP patients across Europe.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "aim," "believe," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE in the U.S. and TAVLESSE in Europe; risks that the FDA, European Medicines Agency (EMA) or other regulatory authorities may make adverse decisions regarding fostamatinib or any of Rigel's product candidates; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the ongoing COVID-19 pandemic may result in further delays in Rigel's studies and trials, or impact Rigel's sales and ability to obtain supply of fostamatinib. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  21. SOUTH SAN FRANCISCO, Calif., June 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference on Tuesday, June 23, 2020 at 10:30 a.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com) 
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering…

    SOUTH SAN FRANCISCO, Calif., June 17, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference on Tuesday, June 23, 2020 at 10:30 a.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com) 

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (wAIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1This product candidate is investigational and has not been established safe or effective by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

    Contact: David Burke

    Phone: 650.624.1232

    Email:

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  22. SOUTH SAN FRANCISCO, Calif., June 11, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be highlighted in a presentation at the Virtual Edition of the 25th EHA Annual Congress taking place June 11-21, 2020. The presentation will be made available on the event's website at www.ehaweb.org/congress/ on Friday, June 12 at 8:30 am CEST.

    In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.

    Fostamatinib disodium…

    SOUTH SAN FRANCISCO, Calif., June 11, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be highlighted in a presentation at the Virtual Edition of the 25th EHA Annual Congress taking place June 11-21, 2020. The presentation will be made available on the event's website at www.ehaweb.org/congress/ on Friday, June 12 at 8:30 am CEST.

    In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.

    Fostamatinib disodium hexahydrate is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the body's immune process that leads to platelet destruction in immune thrombocytopenia (ITP) and proposed red blood cell destruction in warm autoimmune hemolytic anemia (wAIHA). Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets and is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. TAVALISSE is currently being investigated in a Phase 3 trial for the treatment of wAIHA, a rare, serious blood disorder for which there are no approved therapies.

    Poster Presentation

    Abstract #EP1625

    Second-line Therapy for Immune Thrombocytopenia with the Spleen Tyrosine Kinase Inhibitor Fostamatinib

    Presenter: Dr. Nichola Cooper

    Session Topic: 32. Platelets Disorders  

    About ITP

    In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with this disease may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA 

    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.  Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. 

    About TAVALISSE

    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information

    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (wAIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements

    This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, the commercial success of TAVALISSE in the U.S.; Rigel's ability to broaden its pipeline of assets; future drug development plans; the potential for the results of ongoing clinical trials; and the market potential for Rigel's marketed products and product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  23. SOUTH SAN FRANCISCO, Calif., June 3, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to R835, the company's investigational IRAK1/4 inhibitor, will be presented in two oral and two poster presentations at the European League Against Rheumatism (EULAR) 2020 E-Congress taking place June 3-6, 2020. A fifth abstract highlighting R835 has been accepted for publication. The presentations will be made available on the event's website at https://congress.eular.org/ on Wednesday, June 3 at 1:00 AM CEST.

    The presentations will highlight the biological and pharmacological characterization of R835, a potent and selective inhibitor of both interleukin receptor associated kinase (IRAK)1 and IRAK4, and the results…

    SOUTH SAN FRANCISCO, Calif., June 3, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that data related to R835, the company's investigational IRAK1/4 inhibitor, will be presented in two oral and two poster presentations at the European League Against Rheumatism (EULAR) 2020 E-Congress taking place June 3-6, 2020. A fifth abstract highlighting R835 has been accepted for publication. The presentations will be made available on the event's website at https://congress.eular.org/ on Wednesday, June 3 at 1:00 AM CEST.

    The presentations will highlight the biological and pharmacological characterization of R835, a potent and selective inhibitor of both interleukin receptor associated kinase (IRAK)1 and IRAK4, and the results of the completed Phase 1 studies. In multiple pre-clinical rodent models of acute and chronic inflammation, R835 administration resulted in reduced inflammation, and in Phase 1 human studies it showed encouraging pharmacokinetic properties. In an intravenously administered lipopolysaccharide (LPS) challenge study, proof-of-mechanism for R835 was established by demonstrating the suppression of inflammatory cytokine (e.g. TNFa and IL-6) production in healthy volunteers. The results, including the LPS challenge study results, support the continued clinical development of R835 as a novel agent for the treatment of inflammatory and autoimmune diseases.

    Oral Presentations
    Abstract OP0133
    Preclinical efficacy of R835, a novel IRAK1/4 dual inhibitor, in rodent models of joint inflammation
    Presenting Author: Vanessa Taylor, PhD
    Session: Immunity in rheumatic disease
    Date:  Thursday, June 4
    Time: 10:45 AM CEST

    Abstract OP0046
    Targeting IRAK1 and 4 signaling with R835, a novel oral small molecule inhibitor: a potential new treatment for systemic lupus erythematosus
    Presenting Author: Chrystelle Lamagna, PhD
    Session: Pathogenic insights transforming the treatment of Sjögren's and SLE 2020 and beyond
    Date:  Wednesday, June 3
    Time: 4:20 PM CEST

    Poster Presentations
    Abstract THU0219
    First-inhuman Study of Safety, Pharmacokinetics and Pharmacodynamics of IRAK1/4 Inhibitor R835 in Healthy Subjects
    Presenting Author: Lucy Yan, MD, PhD
    Session: Rheumatoid arthritis - non biologic treatment and small molecules
    Date:  Thursday, June 4
    Time: 12:01 AM to 11:59 PM CEST

    Abstract FRI0016
    R835, a novel IRAK1/4 dual inhibitor in clinical development, blocks Toll-Like receptor 4 (TLR4) signaling in human and mouse
    Session: Innate immunity in rheumatic diseases
    Presenting Author: Vanessa Taylor, PhD
    Date:  Friday, June 5
    Time: 12:01 AM to 11:59 PM CEST

    Abstract Publication
    AB0058
    Cell-type specific regulation of IL-1R signaling by R835, a dual IRAK1/4 inhibitor
    Session: Innate immunity in rheumatic diseases

    About R8351
    The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response. Dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease, including psoriasis, arthritis, lupus, multiple sclerosis and gout.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements 
    This release contains forward-looking statements relating to, among other things, Rigel's belief that the results of the LPS challenge study support the progression of clinical development of R835 as a novel agent for the treatment of inflammatory and autoimmune diseases. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  24. SOUTH SAN FRANCISCO, Calif., May 26, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 1:30 p.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing…

    SOUTH SAN FRANCISCO, Calif., May 26, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 1:30 p.m. Eastern Time.

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1This product candidate is investigational and has not been established safe or effective by the U.S. Food and Drug Administration (FDA) or any regulatory authority.

    Contact: David Burke
    Phone: 650.624.1232
    Email:

     

     

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

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  25. SOUTH SAN FRANCISCO, Calif., May 5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the first quarter ended March 31, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "During these extraordinary times, we continue to execute on our business strategy while maintaining our commitment to the well-being of our employees, patients, customers, and community. As the COVID-19 pandemic evolves, we will continue to monitor the impact this will have on our business and operations going forward," said Raul Rodriguez, Rigel's president and…

    SOUTH SAN FRANCISCO, Calif., May 5, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the first quarter ended March 31, 2020, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "During these extraordinary times, we continue to execute on our business strategy while maintaining our commitment to the well-being of our employees, patients, customers, and community. As the COVID-19 pandemic evolves, we will continue to monitor the impact this will have on our business and operations going forward," said Raul Rodriguez, Rigel's president and CEO. "While we began to experience the impact of COVID-19 in the latter part of the first quarter, the performance of our commercial business and progress of enrollment in our warm autoimmune hemolytic anemia clinical trial give us confidence in our ability to regain momentum as the future begins to normalize. We are also exploring opportunities for our earlier stage programs and continue to believe that we can finalize a collaboration by year end.  Additionally, we added $30 million to our financial position through a combination of a milestone payment from Grifols and non-dilutive funding from MidCap Financial."

    Business Update
    In the first quarter of 2020, 1,398 bottles of TAVALISSE were shipped to patients and clinics with net product sales increasing 57% year over year to $12.7 million.  During the quarter, the company experienced typical first quarter reimbursement issues such as the resetting of co-pays and the Medicare donut hole, and was also impacted negatively by the COVID-19 pandemic in the latter part of the quarter. As of March 31, a total of 591 bottles remained in its distribution channels, a decrease of 5 bottles from the previous quarter.

    Resources have been deployed to enable Rigel's field-based employees to engage remotely with health care providers and their offices. These virtual engagements have enabled its field team to support existing prescribers, as well as partner with new prescribers to identify appropriate patients for TAVALISSE.

    Rigel is exploring opportunities to collaborate with research institutes to investigate the potential of TAVALISSE to treat COVID-19 pneumonia and related acute respiratory distress syndrome (ARDS). The SYK signaling pathway plays a known role in mediating the release of cytokines in response to the COVID-19 virus, providing scientific rationale for investigating the potential benefit of SYK-inhibition in these patients.

    The company's FORWARD study, a pivotal Phase 3 clinical trial in warm autoimmune hemolytic anemia (AIHA) has enrolled 41 patients to date. Currently, the FORWARD study has over 80 active clinical trial sites established across 22 countries. A vast majority of these sites have temporarily postponed new patient enrollment due to the ongoing COVID-19 pandemic. As such, Rigel is no longer able to provide guidance on the timing of enrollment completion. Enrollment is expected to regain momentum as conditions permit across its over 80 globally diverse clinical sites.

    Rigel currently does not anticipate disruption in supply of TAVALISSE tablets and drug substance to meet the needs of its U.S. ITP commercial business, as well as its collaborative partners and clinical trials worldwide.

    In February 2020, Rigel received a $20.0 million milestone payment from its collaborative partner Grifols, S.A. (Grifols). The payment was received upon the European Commission's (EC) approval of the marketing authorization application (MAA) for fostamatinib for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. In addition, as a result of the EC approval, $25.0 million of the $30.0 million upfront fee that Rigel previously received from Grifols will no longer be repayable by Rigel to Grifols. Fostamatinib will be marketed in Europe under the brand name TAVLESSE® (fostamatinib).

    In May 2020, Rigel accessed the second $10.0 million tranche from its $60.0 million term loan credit facility with MidCap Financial. The facility provides the company with access to an additional $40.0 million which is subject to the achievement of certain conditions.

    Financial Update 
    For the first quarter of 2020, Rigel reported net income of $21.2 million, or $0.13 per share, compared to a net loss of $17.6 million, $0.11 per share, in the same period of 2019.

    In the first quarter of 2020, total revenues were $55.8 million, consisting of $12.7 million in net product sales and $43.1 million in contract revenues from collaborations. Net product sales increased by 57% compared to $8.1 million in the first quarter of 2019.

    Contract revenues from collaborations of $43.1 million in the first quarter of 2020 relate to revenue from the upfront fee Rigel previously received from Grifols in the first quarter of 2019, as well as the milestone payment received from Grifols in the first quarter of 2020 upon EC approval of the MAA for fostamatinib in Europe. The Company will recognize the remaining $2.2 million deferred portion of the above payments upon performance of certain research and development services under the collaboration agreement with Grifols.

    Rigel reported total costs and expenses of $34.7 million in the first quarter of 2020, compared to $31.0 million for the same period in 2019.  The increase in total costs and expenses was primarily due to the increase in third-party costs related to Rigel's ongoing pivotal Phase 3 study in warm AIHA, research and development costs related to other clinical programs, and personnel-related costs, partially offset by stock-based compensation expense.

    Rigel will continue to undertake efforts to prevent or minimize disruptions to its business and operations while monitoring for new developments related to the evolving COVID-19 pandemic. Rigel does not yet know the full impact of such disruptions on its business, operations or financial condition.

    As of March 31, 2020, Rigel had cash, cash equivalents and short-term investments of $95.9 million, compared to $98.1 million as of December 31, 2019.

    Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
    Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.  Warm AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

    About TAVALISSE
    Indication
    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information
    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments, and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; the sufficiency of Rigel's supplies of TAVALISSE; the commercialization of TAVLESSE in Europe and the timing thereof; the utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA); the impact of the COVID-19 pandemic on Rigel's results and operations; Rigel's ability to complete enrollment in its phase 3 clinical trial for AIHA and the timing thereof; Rigel's ability to further develop its clinical stage products; the scientific rationale for exploring use of fostamatinib to treat COVID-19 and related conditions; and Rigel's partnering efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "may," "expects" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. In addition, the COVID-19 pandemic may result in further delays in Rigel's studies, trials and sales, or impact Rigel's ability to obtain supply of TAVALISSE. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)











    Three Months Ended March 31,



    2020

    2019



    (unaudited)





    Revenues:




    Product sales, net

    $         12,680

    $              8,054


    Contract revenues from collaborations 

    43,081

    4,570


    Total revenues

    55,761

    12,624





    Costs and expenses:




    Cost of product sales

    155

    107


    Research and development (see Note A)  

    16,149

    10,949


    Selling, general and administrative (see Note A)

    18,430

    19,946


         Total costs and expenses

    34,734

    31,002

    Loss from operations 

    21,027

    (18,378)

    Interest income 

    358

    780

    Interest expense

    (142)

    Net income (loss)

    $         21,243

    $          (17,598)





    Net income (loss) per share




    Basic

    $             0.13

    $              (0.11)


    Diluted

    $             0.13

    $              (0.11)





    Weighted-average shares used in computing net income (loss) per share



    Basic

    168,469

    167,173


    Diluted

    168,568

    167,173









    Note A







    Stock-based compensation expense included in:




    Selling, general and administrative

    $           1,330

    $              2,166


    Research and development

    694

    787



    $           2,024

    $              2,953










    SUMMARY BALANCE SHEET DATA


    (in thousands)







    March 31,

    December 31,



    2020

    2019 (1)



     (unaudited) 



    Cash, cash equivalents and short-term investments 

    $         95,926

    $            98,078


    Total assets 

    143,363

    147,569


    Stockholders' equity

    78,499

    53,815





    (1)

    Derived from audited financial statements







     

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  26. SOUTH SAN FRANCISCO, Calif., May 1, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that, due to public health and safety concerns related to the coronavirus ("COVID-19") pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees, and others, it will host its 2020 Annual Meeting of Stockholders ("Annual Meeting") as a virtual-only meeting that will be held via live audio webcast. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    The previously announced date and time of the Annual Meeting, Thursday, May 14, 2020

    SOUTH SAN FRANCISCO, Calif., May 1, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that, due to public health and safety concerns related to the coronavirus ("COVID-19") pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees, and others, it will host its 2020 Annual Meeting of Stockholders ("Annual Meeting") as a virtual-only meeting that will be held via live audio webcast. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    The previously announced date and time of the Annual Meeting, Thursday, May 14, 2020 at 9:00 a.m. Pacific Time, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive Proxy Statement (the "Notice and Proxy Statement"), has not changed. Online access to the Annual Meeting will begin at 8:45 a.m. Pacific Time. Stockholders will not be able to attend the Annual Meeting in person.

    Attending the Virtual Meeting as a Stockholder of Record
    Rigel's stockholders of record as of March 20, 2020 (the "Record Date") can attend the Annual Meeting by accessing the meeting center at www.virtualshareholdermeeting.com/RIGL2020 and entering the 16-digit control number on the proxy card or Notice of Internet Availability of Proxy Materials previously received. The webcast of the Annual Meeting will be archived for one year after the date of the Annual Meeting at www.virtualshareholdermeeting.com/RIGL2020. Instructions on how to connect to the Annual Meeting and participate via the Internet, including how to demonstrate proof of stock ownership, are also available at the meeting website.

    If you do not have your 16-digit control number, you will be able to access and listen to the Annual Meeting, but you will not be able to vote your shares or submit questions during the Annual Meeting. See caption below titled "Attending the Annual Meeting as a Guest." 

    Attending the Virtual Meeting as a Beneficial Owner
    Beneficial stockholders as of the Record Date (i.e. shares held in "street name" through an intermediary, such as a bank or broker), who want to attend the Annual Meeting can attend using the 16-digit control number found on the notice and instructions received from their broker or other nominee. 

    Asking Questions
    If you are attending the Annual Meeting as stockholder of record or beneficial owner, questions can be submitted by accessing the meeting center at www.virtualshareholdermeeting.com/RIGL2020 and entering your 16-digit control number. Instructions on how to participate in the Annual Meeting are available on the meeting website.

    Voting Shares
    Stockholders of record and beneficial owners will be able to vote their shares electronically during the Annual Meeting by entering the Annual Meeting using the 16-digit control number. Instructions on how to vote while participating in the Annual Meeting live via the Internet are posted at www.virtualshareholdermeeting.com/RIGL2020.

    Rigel encourages stockholders to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.
    The proxy materials, including the proxy card and Notice of Internet Availability of Proxy Materials, previously distributed along with the Notice and Proxy Statement, will not be updated to reflect the change in location and may continue to be used to vote shares in connection with the Annual Meeting.

    Attending the Annual Meeting as a Guest
    Guests may enter the Annual Meeting in "listen-only" mode by entering the Annual Meeting at www.virtualshareholdermeeting.com/RIGL2020 and entering the information requested in the "Guest Login" section. Guests will not have the ability to vote or ask questions during the Annual Meeting.

    List of Stockholders
    A list of stockholders entitled to vote at the Annual Meeting will be available for examination for any purpose germane to the Annual Meeting for ten days prior to the Annual Meeting. You may email Rigel at  to coordinate arrangements to view the stockholder list. The stockholder list will also be available during the Annual Meeting at www.virtualshareholdermeeting.com/RIGL2020. Instructions on how stockholders of records can view the stockholder list during the Annual Meeting are available on the meeting website. 

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments, and will be marketed in Europe under the name TAVLESSE™ (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  27. SOUTH SAN FRANCISCO, Calif., April 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its first quarter 2020 financial results after market close on Tuesday, May 5, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com.  The webcast will be archived…

    SOUTH SAN FRANCISCO, Calif., April 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its first quarter 2020 financial results after market close on Tuesday, May 5, 2020.  Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international).  The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com.  The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments, and will be marketed in Europe under the name TAVLESSE™ (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

    Please see www.TAVALISSE.com for the full Prescribing Information.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Contact: David Burke
    Phone: 650.624.1232
    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  28. SOUTH SAN FRANCISCO, Calif., Feb. 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the fourth quarter and full year ended December 31, 2019, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "We are entering 2020 with a clear plan to drive shareholder value for Rigel," said Raul Rodriguez, Rigel's president and CEO. "We see substantial opportunities for TAVALISSE to meet patient needs in the growing adult chronic ITP market, particularly as an early line therapy. Utilization in these less refractory patients continues to grow with…

    SOUTH SAN FRANCISCO, Calif., Feb. 27, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the fourth quarter and full year ended December 31, 2019, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "We are entering 2020 with a clear plan to drive shareholder value for Rigel," said Raul Rodriguez, Rigel's president and CEO. "We see substantial opportunities for TAVALISSE to meet patient needs in the growing adult chronic ITP market, particularly as an early line therapy. Utilization in these less refractory patients continues to grow with the support of ongoing physician education and data generation. To expand the range of TAVALISSE indications, we are conducting a Phase 3 trial in warm AIHA and expect to complete patient enrollment midyear. In addition, we are extremely excited about the potential of our early stage candidates and are currently exploring partnership opportunities that would enable Rigel to realize near-term value while also participating meaningfully in the upside of these programs."

    Business Update
    At the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in December 2019, the company presented post-hoc data analysis from its Phase 3 clinical program of TAVALISSE in adult patients with chronic ITP. In this analysis, 32 patients received fostamatinib as a second-line therapy, of which, 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib. These data highlight the potential benefit of using TAVALISSE in earlier lines of therapy.

    In February 2020, Rigel received a $20.0 million payment from its collaborative partner Grifols, S.A. (Grifols). The payment is comprised of $17.5 million for the European Commission's approval of the marketing authorization application for fostamatinib for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments and a $2.5 million creditable advance royalty payment based on the terms of the collaboration agreement. Fostamatinib will be marketed in Europe under the brand name TAVLESSE™ (fostamatinib). Grifols is planning to launch the product in the second quarter of 2020.

    Enrollment is ongoing in Rigel's Phase 3 pivotal trial in warm AIHA, FORWARD (Fostamatinib Research in Warm Antibody AIHA Disease). A total of 34 patients have been randomized to date. The trial remains on track to complete enrollment in mid-2020.

    In February 2020, Rigel's partner Kissei Pharmaceuticals Co., Ltd. (Kissei) was granted orphan drug designation from the Japanese Ministry of Health, Labour and Welfare for R788 (fostamatinib) in chronic idiopathic thrombocytopenic purpura.

    Financial Update 
    For the fourth quarter of 2019, Rigel reported a net loss of $17.2 million, or $0.10 per share, compared to net income of $3.2 million, or $0.02 per share, in the same period of 2018.

    In the fourth quarter of 2019, total revenues were $15.4 million, consisting of $13.8 million in net product sales and $1.6 million in contract revenues from collaborations. Net product sales of $13.8 million increased by 90% compared to $7.3 million in the fourth quarter of 2018. This increase reflects the expanding patient and prescriber base for TAVALISSE and the growing persistency rate for refills at month 4, which is approximately 54%.

    Contract revenues from collaborations of $1.6 million for the fourth quarter ended December 31, 2019 consists of a $1.5 million fee earned pursuant to an amendment of the license and collaboration agreement with Aclaris Therapeutics, Inc. (Aclaris) in October 2019, as well as deferred revenue from Rigel's collaboration with Grifols related to the performance of certain research and development services.

    Rigel reported total costs and expenses of $32.7 million in the fourth quarter of 2019, compared to $35.3 million for the same period in 2018. The decrease in costs and expenses was primarily due to decreases in personnel-related expenses and various third-party costs.

    For the full year ended December 31, 2019, Rigel reported a net loss of $66.9 million, or $0.40 per share, compared to a net loss of $70.5 million, or $0.44 per share, for the same period of 2018.

    Rigel reported total revenues of $59.3 million for the year ended December 31, 2019, consisting of $43.8 million in net product sales and $15.5 million in revenues related to Rigel's collaboration agreements with Grifols, Kissei, Aclaris, and Impact Biomedicines, Inc.

    Total costs and expenses for the year ended December 31, 2019, were $128.4 million, compared to $117.2 million, for the same period of 2018. The increase in total costs and expenses was primarily due to the increases in third party costs related to Rigel's ongoing pivotal Phase 3 study in warm AIHA, personnel-related costs, on-going commercialization of TAVALISSE in adult chronic ITP, and research and development costs related to its Phase 1 study in RIP.

    As of December 31, 2019, Rigel had cash, cash equivalents and short-term investments of $98.1 million, compared to $128.5 million as of December 31, 2018. Rigel previously announced that in September 2019, we entered into a $60.0 million term loan credit facility with MidCap Financial. At closing, $10.0 million was funded to Rigel in an initial tranche. The facility also gives Rigel the ability to access an additional $50.0 million, of which $40.0 million is subject to the achievement of certain customary conditions.

    Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
    Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

    About R8351
    The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response, and dysregulation of these pathways can lead to a variety of inflammatory pathological conditions. R835 treatment demonstrates amelioration of clinical symptoms in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.

    About R5521
    The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting protein kinase (RIP1). RIP1 is believed to play a critical role in necroptosis. Necroptosis is a form of regulated cell death where the rupturing of cells leads to the dispersion of their inner contents, which induces immune responses and enhances inflammation. In preclinical studies, R552 prevented joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage. The safety and efficacy of R552 has not been established by the FDA or any healthcare authority.

    About TAVALISSE
    Indication

    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information
    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments, and will be marketed in Europe under the name TAVLESSE™ (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; the commercialization of TAVLESSE in Europe and the timing thereof; Rigel's ability to grow utilization of TAVALISSE in early line therapy; the utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA); Rigel's ability to complete enrollment in its phase 3 clinical trial for AIHA and the timing thereof; Rigel's ability to further develop its clinical stage product candidates; and Rigel's partnering efforts. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential", "may", "expects", and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)



















    Three Months Ended December 31,


    Year Ended December 31,




    2019

    2018


    2019

    2018




    (unaudited)













    Revenues:








    Product sales, net

    $  13,829

    $     7,295


    $  43,772

    $  13,947



    Contract revenues from collaborations 

    1,571

    30,562


    15,516

    30,562



    Total revenues

    15,400

    37,857


    59,288

    44,509










    Costs and expenses:








    Cost of product sales

    178

    188


    906

    287



    Research and development (see Note A) 

    14,247

    13,767


    52,885

    46,903



    Selling, general and administrative (see Note A)

    18,312

    21,370


    74,588

    70,002



         Total costs and expenses

    32,737

    35,325


    128,379

    117,192










    Income (loss) from operations 

    (17,337)

    2,532


    (69,091)

    (72,683)


    Interest income 

    464

    696


    2,532

    2,203


    Interest expense

    (327)

    -


    (335)

    -










    Net income (loss)

    $ (17,200)

    $     3,228


    $ (66,894)

    $ (70,480)










    Net income (loss) per share, basic and diluted

    $     (0.10)

    $       0.02


    $     (0.40)

    $     (0.44)










    Weighted-average shares used in computing net income (loss) per share








    Basic

    167,619

    166,680


    167,400

    160,529



    Diluted

    167,619

    167,617


    167,400

    160,529


















    Note A















    Stock-based compensation expense included in:








    Selling, general and administrative

    $       934

    $     1,470


    $    6,453

    $    5,383



    Research and development

    477

    587


    2,662

    2,321




    $    1,411

    $     2,057


    $    9,115

    $    7,704



















    SUMMARY BALANCE SHEET DATA






    (in thousands)















    December 31,







    2019

    2018














    Cash, cash equivalents and short-term investments 

    $  98,078

    $ 128,537






    Total assets 

    147,569

    139,109






    Stockholders' equity

    53,815

    109,877





     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-reports-fourth-quarter-and-full-year-2019-financial-results-and-provides-business-update-301012875.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  29. SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its fourth quarter and year end 2019 financial results after market close on Thursday, February 27, 2020. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for…

    SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its fourth quarter and year end 2019 financial results after market close on Thursday, February 27, 2020. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results.

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product has been approved by the European Commission for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments, and will be marketed in Europe under the name TAVLESSE® (fostamatinib).

    Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Please see www.TAVALISSE.com for the full Prescribing Information.

    Contact: David Burke
    Phone: 650.624.1232
    Email: m

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-announces-conference-call-and-webcast-to-report-fourth-quarter-and-year-end-financial-results-301008142.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  30. SOUTH SAN FRANCISCO, Calif., Jan. 13, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today provided a business update, including preliminary product revenue and total TAVALISSE® (fostamatinib disodium hexahydrate) bottles for the quarter; the European Commision's (EC) approval of fostamatinib disodium hexahydrate (fostamatinib) for adult patients with chronic immune thrombocytopenia (ITP); and enrollment progress in its Phase 3 pivotal trial for warm autoimmune hemolytic anemia (AIHA). The company's president and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 16 at 7:30am PT at the 38th Annual J.P. Morgan Healthcare Conference.

    "Rigel has built a solid…

    SOUTH SAN FRANCISCO, Calif., Jan. 13, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today provided a business update, including preliminary product revenue and total TAVALISSE® (fostamatinib disodium hexahydrate) bottles for the quarter; the European Commision's (EC) approval of fostamatinib disodium hexahydrate (fostamatinib) for adult patients with chronic immune thrombocytopenia (ITP); and enrollment progress in its Phase 3 pivotal trial for warm autoimmune hemolytic anemia (AIHA). The company's president and CEO, Raul Rodriguez, will provide a more detailed company overview during his presentation taking place on Thursday, January 16 at 7:30am PT at the 38th Annual J.P. Morgan Healthcare Conference.

    "Rigel has built a solid foundation for continued growth, anchored by increased revenues from our U.S. commercial business. With European approval of fostamatinib, we expect to generate revenue from royalty payments beginning in the second half of the year, and importantly, we will receive a $20 million milestone from our partner, Grifols, S.A.," stated Mr. Rodriguez, Rigel's president and CEO. "Enrollment of our Phase 3 clinical trial in warm AIHA is accelerating with the ongoing activation of trial sites. This is an extremely attractive market for Rigel given the lack of an FDA-approved therapy and the synergies with our ITP commercial business. Additionally, we are making meaningful progress with our novel IRAK 1/4 and RIP1 inhibitor programs and are excited about their potential value."

    Preliminary Financial Update
    While Rigel is still in the process of determining final results for the fourth quarter of 2019, the company expects to report net product sales of approximately $13.8 million, compared to $7.3 million in the same period of 2018, an increase of 90%.

    Contract revenues from collaborations for the quarter ended December 31, 2019, are expected to be approximately $1.6 million, which consists of a $1.5 million fee earned pursuant to an amendment in October 2019 of the license and collaboration agreement with Aclaris dated August 27, 2015, as well as deferred revenue from its collaboration with Grifols related to the performance of certain research and development services.

    For the fourth quarter 2019, Rigel expects to report total revenues of approximately $15.4 million.

    The company expects to report cash, cash equivalents and short-term investments as of December 31, 2019 of approximately $98.0 million, compared to $128.5 million as of December 31, 2018.

    The above information is preliminary, has not been audited and is subject to change upon completion of the audit of the company's financial statements as of and for the year ended December 31, 2019.

    Commercial Update
    Growing TAVALISSE in the U.S. Market
    During the fourth quarter of 2019, a total of 1,518 bottles of TAVALISSE were sold in the U.S. of which 1,422 were shipped directly to patients and clinics. The refill rate at month 4 increased to approximately 54%, reflecting the benefit patients are experiencing as TAVALISSE is used more frequently in earlier line treatment and physicians become more experienced with its use.

    Heading into 2020, Rigel is poised for further growth with plans to expand its salesforce by six people in key markets. In addition, the company intends to continue its ongoing data initiatives and leverage recently presented post-hoc data showing a 78% response rate in ITP patients who received TAVALISSE in second line use.

    EC Approval of Fostamatinib and Product Launch
    Rigel today announced that it has received EC approval of its marketing authorization application (MAA) for fostamatinib for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. With this approval, the company will receive a milestone payment of $20 million based on terms of its collaboration with Grifols, S.A. During the regulatory review process, Grifols began preparing to launch the product in the major European markets and is now able to begin the regulatory processes for marketing in the individual countries. The company expects to generate incremental revenue from European sales of fostamatinib in the second half of this year in the form of royalty payments.

    Portfolio Update
    Phase 3 Trial in Warm AIHA
    Since the launch of FORWARD (Fostamatinib Research in Warm Antibody AIHA Disease), Rigel's Phase 3 pivotal trial in warm AIHA, the company has been working with clinics and regulatory authorities and has established a vast majority of the more than 100 clinical trial sites planned across 22 countries. With the number of opened sites growing rapidly, over 45 in the last three months, enrollment of the trial has accelerated as planned with 15 of 20 total patients enrolled in the last two months. The trial remains on track to complete enrollment in mid-2020.

    Clinical Development Pipeline
    In the fourth quarter of 2019, Rigel announced results from its Phase 1 clinical trial of R8351, its interleukin-1 receptor-associated kinase 1/4 (IRAK1/4) inhibitor. This novel molecule is the only asset in clinical development that is a dual inhibitor of IRAK1 and IRAK4 and has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. The Phase 1 trial established proof-of-mechanism by demonstrating the inhibition of inflammatory cytokine production in an LPS (lipopolysaccharide) challenge.

    In addition, Rigel recently initiated a Phase 1 trial of its receptor-interacting protein kinase (RIP1) inhibitor, R5521. RIP1 is believed to play a critical role in necroptosis, a form of regulated cell death implicated in inflammatory and neurodegenerative diseases. Initial data from Rigel's ongoing Phase 1 suggests R552 has an attractive pharmacokinetic (PK) and safety profile with a half-life of approximately 15 hours. In earlier preclinical studies, the molecule was shown to prevent joint and skin inflammation in a RIP1 kinase-mediated murine model.

    Both assets target pathways that are of high interest in the biopharma industry and are widely thought to have significant potential in the treatment of inflammatory and immune-mediated diseases.

    38th Annual J.P. Morgan Webcast Presentation Details
    Rigel's presentation will be webcast and is scheduled to take place Thursday, January 16 at 7:30am PT. To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to the website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.  Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

    About R8351
    The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response, and dysregulation of these pathways can lead to a variety of inflammatory pathological conditions. R835 treatment demonstrates amelioration of clinical symptoms in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.

    About R5521
    The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting protein kinase (RIP1). RIP1 is believed to play a critical role in necroptosis. Necroptosis is a form of regulated cell death where the rupturing of cells leads to the dispersion of their inner contents, which induces immune responses and enhances inflammation. In preclinical studies, R552 prevented joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage. The safety and efficacy of R552 has not been established by the FDA or any healthcare authority.

    About TAVALISSE
    Indication
    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information
    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's clinical programs include a Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; Rigel's ability to broaden its pipeline of assets targeting immune-mediated diseases; Rigel's efforts to expand fostamatinib in Europe and to expand its salesforce in key markets; Rigel's regulatory and collaborative efforts in Europe to make fostamatinib available to ITP patients more globally; the utility of fostamatinib in other indications, including warm autoimmune hemolytic anemia; Rigel's ability to achieve development and commercial milestones; Rigel's expected operating results for the quarter ending and as of December 31, 2019, including net sales and cash, cash equivalents and short-term investments; expectations related to the market opportunity for ITP in the European market, and the design, timing, enrollment and results of Rigel's clinical trials.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "goals", "potential", "preliminary", "may", "expects", and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  31. SOUTH SAN FRANCISCO, Calif., Jan. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and CEO, is scheduled to present a company overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30am PT in San Francisco, CA. 

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and…

    SOUTH SAN FRANCISCO, Calif., Jan. 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and CEO, is scheduled to present a company overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30am PT in San Francisco, CA. 

    To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Please see www.TAVALISSE.com for full Prescribing Information.

    IR Contact: David Burke
    Phone: 650.624.1232
    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  32. SOUTH SAN FRANCISCO, Calif., Dec. 17, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that Eldon Mayer has resigned from his position as chief commercial officer effective December 23, 2019, to pursue an opportunity with an emerging company.

    "We would like to thank Eldon for his efforts to successfully bring Rigel's first product to market," said Raul Rodriguez, president and CEO. "Our highly experienced and motivated commercial team with proven senior leadership has grown U.S. TAVALISSE sales on a quarterly basis since launch and we are well positioned to maintain this upward momentum. Our goal is to continue to increase U.S. ITP market share for TAVALISSE while also focusing on the potential of this product…

    SOUTH SAN FRANCISCO, Calif., Dec. 17, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that Eldon Mayer has resigned from his position as chief commercial officer effective December 23, 2019, to pursue an opportunity with an emerging company.

    "We would like to thank Eldon for his efforts to successfully bring Rigel's first product to market," said Raul Rodriguez, president and CEO. "Our highly experienced and motivated commercial team with proven senior leadership has grown U.S. TAVALISSE sales on a quarterly basis since launch and we are well positioned to maintain this upward momentum. Our goal is to continue to increase U.S. ITP market share for TAVALISSE while also focusing on the potential of this product in warm AIHA, for which we remain on track to complete enrollment in mid-2020."

    Rigel's senior commercial leadership team, all of whom have been with Rigel since prior to the launch of TAVALISSE® (fostamatinib disodium hexahydrate) tablets and played significant roles in establishing the current commercial infrastructure, will report directly to Mr. Rodriguez during this interim period. Rigel has commenced a search for a new chief commercial officer focusing on an experienced leader with a track record of driving market share growth and managing a product in multiple indications.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.  Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R8351, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R5521, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Please see www.TAVALISSE.com for full Prescribing Information. 

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, Rigel's efforts to identify a chief commercial officer, the commercial goals of TAVALISSE sales in the U.S. and the potential of fostamatinib in AIHA.  Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "goals", "potential", "may", "expects", and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-announces-chief-commercial-officer-transition-300976447.html

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  33. SOUTH SAN FRANCISCO, Calif., Nov. 15, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion for Rigel's Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.

    The CHMP reviews medical product applications and provides their opinion to the European Commission (EC), which has the authority to approve medicines for use in Europe. The positive opinion will now be reviewed by the EC, which will issue a decision on the approval…

    SOUTH SAN FRANCISCO, Calif., Nov. 15, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion for Rigel's Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.

    The CHMP reviews medical product applications and provides their opinion to the European Commission (EC), which has the authority to approve medicines for use in Europe. The positive opinion will now be reviewed by the EC, which will issue a decision on the approval of fostamatinib in Europe within approximately 70 days.

    "We are extremely encouraged by the CHMP's positive opinion and look forward to the final decision on our MAA from the European Commission," said Raul Rodriguez, Rigel's president and CEO. "We are excited by the potential to provide adult chronic ITP patients in Europe with a new treatment option that addresses the primary cause of their disease. Our European partner, Grifols, is preparing diligently for a prospective commercial launch in 2020."

    The CHMP based its opinion on data provided from the FIT Phase 3 clinical program, which included two randomized placebo-controlled trials (FIT1 and FIT2) and an open-label extension trial (FIT3). The MAA included data from 163 ITP patients and was supported by a safety database of more than 4,600 subjects across all other indications in which fostamatinib has been evaluated.

    Fostamatinib is commercially available in the U.S. and is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in U.S. adult patients with chronic ITP who have had an insufficient response to a previous treatment. Europe is the second largest market for adult chronic ITP treatments after the United States.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About Rigel (www.rigel.com
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the CHMP opinion  and the potential approval and subsequent 2020 commercial launch in Europe of fostamatinib for the treatment of chronic ITP, and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "potential," "will," "may," "expect," "prospective," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Contact: David Burke
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  34. SOUTH SAN FRANCISCO, Calif., Nov. 13, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 4:40pm GMT

    To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that…

    SOUTH SAN FRANCISCO, Calif., Nov. 13, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Dean Schorno, the company's chief financial officer, is scheduled to present a company overview at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 4:40pm GMT

    To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of TAVALISSE in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) inhibitor program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for full Prescribing Information.

    IR Contact: David Burke
    Phone: 650.624.1232
    Email:

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-to-present-at-jefferies-2019-london-healthcare-conference-300957055.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  35. SOUTH SAN FRANCISCO, Calif., Nov. 7, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets has been accepted for two poster presentations at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition to be held December 7-10, 2019, in Orlando, FL.

    Rigel conducted a post-hoc data analysis from a Phase 3 clinical program of TAVALISSE in adult patients with immune thrombocytopenia (ITP). In this analysis, 32 patients received fostamatinib as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib…

    SOUTH SAN FRANCISCO, Calif., Nov. 7, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that data related to TAVALISSE® (fostamatinib disodium hexahydrate) tablets has been accepted for two poster presentations at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition to be held December 7-10, 2019, in Orlando, FL.

    Rigel conducted a post-hoc data analysis from a Phase 3 clinical program of TAVALISSE in adult patients with immune thrombocytopenia (ITP). In this analysis, 32 patients received fostamatinib as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.

    "These data show a high response rate in the early-line treatment of adult ITP," said Raul Rodriguez, Rigel's President and CEO. "We believe that these data, coupled with TAVALISSE's differentiated and targeted mechanism of action, provide an attractive treatment approach for early-line patients. These patients represent the vast majority of the adult ITP population."

    Additionally, in a Phase 2 open-label study of fostamatinib in patients with warm antibody autoimmune hemolytic anemia (wAIHA), data showed that 44% (11/25) of evaluable patients met the primary efficacy endpoint of a hemoglobin (Hgb) level >10 g/dL with an increase of ≥2 g/dL from baseline by week 24. Including one late responder at week 30, the overall response rate was 48% (12/25). Adverse events were manageable and consistent with those previously reported with fostamatinib.

    Fostamatinib disodium hexahydrate is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the body's immune process that leads to platelet destruction in ITP and proposed red blood cell destruction in AIHA. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets and is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. TAVALISSE is currently being investigated in a Phase 3 trial for wAIHA, a rare, serious blood disorder for which there are no approved therapies.

    Poster Presentations
    Abstract #1069
    Enhanced Responses to Fostamatinib as Second-Line Therapy and in Persistent Immune Thrombocytopenia (ITP) Patients
    Session Name: 311. Disorders of Platelet Number or Function: Poster I
    Presenter: Ralph Boccia
    Date: Saturday, December 7, 2019
    Presentation Time: 5:30 PM-7:30 PM EST
    Location:  Hall B (Orange County Convention Center)

    Abstract #3518
    Fostamatinib1, a Spleen Tyrosine Kinase (SYK) Inhibitor, for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Final Results of the Phase 2, Multicenter, Open-Label Study
    Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
    Presenter: Kerry Rogers
    Date: Monday, December 9, 2019
    Presentation Time: 6:00 PM - 8:00 PM EST
    Location: Hall B (Orange County Convention Center)

    The conference abstracts can be accessed here.

    To learn more about Rigel Pharmaceuticals and TAVALISSE® visit booth #415 during ASH 2019.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.  Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

    About TAVALISSE
    Indication 
    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information
    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)
    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1 The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the safety, tolerability, design, timing and results of Rigel's products, product candidates and clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned", "will", "may", "expects", "anticipates", "estimates", "hopes", "believes" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke
    Phone: 650.624.1232
    Email: 

    Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

     

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  36. SOUTH SAN FRANCISCO, Calif., Nov. 5, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the third quarter ended September 30, 2019, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "We continue to demonstrate progress in all of the key value drivers for Rigel," said Raul Rodriguez, Rigel's president and CEO. "Our commercial business continues to expand with U.S. sales increasing 15% quarter over quarter. We are moving forward with regulatory and collaborative efforts in Europe, Japan, and Canada to potentially make fostamatinib available…

    SOUTH SAN FRANCISCO, Calif., Nov. 5, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the third quarter ended September 30, 2019, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    "We continue to demonstrate progress in all of the key value drivers for Rigel," said Raul Rodriguez, Rigel's president and CEO. "Our commercial business continues to expand with U.S. sales increasing 15% quarter over quarter. We are moving forward with regulatory and collaborative efforts in Europe, Japan, and Canada to potentially make fostamatinib available to ITP patients globally; our Phase 3 trial for fostamatinib in warm autoimmune hemolytic anemia is enrolling; and we have strengthened our pipeline with progress in our IRAK1/4 and RIP1 programs.  All of these achievements create valuable opportunities for Rigel both in the near and long term."

    Financial Update

    For the third quarter of 2019, Rigel reported a net loss of $11.5 million, or $0.07 per share, compared to a net loss of $23.8 million, or $0.14 per share, in the same period of 2018.

    For the third quarter of 2019, Rigel reported net product sales from TAVALISSE of $11.7 million, compared to $4.9 million in the same period of 2018. The increase in net product sales reflects the continued expansion of TAVALISSE use since its commercial launch in May 2018.

    Contract revenues from collaborations were $9.1 million for the three months ended September 30, 2019, of which $4.0 million related to a development milestone from Aclaris Therapeutics, Inc., $3.8 million related to a commercial launch milestone from Impact Biomedicines, Inc., which was subsequently acquired by Celgene Corp., and $1.3 million from its collaboration agreements with Grifols, S.A. and Kissei Pharmaceutical Co., Ltd. related to performance of certain research and development services. There were no contract revenues from collaborations during the three months ended September 30, 2018.

    Rigel reported total costs and expenses of $32.9 million in the third quarter of 2019, compared to $29.2 million for the same period in 2018. The increase in costs and expenses was primarily due to increased research and development costs related to its ongoing Phase 3 study in warm autoimmune hemolytic anemia (AIHA).

    For the nine months ended September 30, 2019, Rigel reported a net loss of $49.7 million, or $0.30 per share, compared to a net loss of $73.7 million, or $0.47 per share, for the same period of 2018.

    Rigel reported total revenues of $43.9 million for the nine months ended September 30, 2019, compared to $6.7 million for the same period in 2018. Total revenues for the nine months ended September 30, 2019, consisted of $29.9 million in net product sales and $14.0 million in revenues related to Rigel's collaboration agreements with Grifols, S.A., Kissei Pharmaceutical Co., Ltd., Aclaris Therapeutics, Inc., and Impact Biomedicines, Inc. Total revenues for the nine months ended September 30, 2018 consisted of $6.7 million in net product sales.

    Total costs and expenses for the nine months ended September 30, 2019, were $95.6 million, compared to $81.9 million, for the same period of 2018. The increase in total costs and expenses was primarily related to the increase in personnel costs for Rigel's customer-facing team, as well as third party costs related to Rigel's ongoing commercialization of TAVALISSE in adult chronic ITP, and research and development costs related to its ongoing Phase 3 study in warm AIHA.

    As of September 30, 2019, Rigel had cash, cash equivalents and short-term investments of $107.5 million, compared to $128.5 million as of December 31, 2018.

    Business Update

    • Increased net product sales by 15% to $11.7 million from $10.2 million in the second quarter of 2019.
    • Received positive trend vote from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on the Marketing Authorization Application (MAA) for fostamatinib indicated for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.
    • Entered into exclusive license agreements with Medison Pharma to commercialize fostamatinib in Canada and Israel. Rigel received an upfront payment of $5 million, which included an advanced royalty payment, with the potential for approximately $35 million in regulatory and commercial milestones. In addition, Rigel will receive royalty payments beginning at 30% of net sales after credit for the advanced royalty payment is fulfilled.
    • Began enrollment of a Phase 3 clinical trial of TAVALISSE in patients with warm antibody AIHA. Enrollment is expected to complete in mid-2020 with topline results in mid-2021.
    • Completed a Phase 1 clinical trial of its IRAK1/4 inhibitor, R835, which showed inhibition of cytokine production in a proof-of-mechanism study done in humans. R835 showed tolerability and a positive PK profile, supporting continued development of the molecule.
    • Initiated a Phase 1 clinical trial of R552, a receptor-interacting protein kinase (RIP1) inhibitor. RIP1 is a key driver of necroptosis, a form of cell death that is implicated in a broad range of inflammatory processes.
    • Appointed Wolfgang Dummer, MD, PhD to the role of Chief Medical Officer. Dr. Dummer has more than 20 years of clinical and drug development experience with companies such as Genentech, Inc., Biomarin Pharmaceuticals, Inc., and Aridis Pharmaceuticals, Inc., as well as an extensive academic history.

    About ITP
    In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing.  Common symptoms of ITP are excessive bruising and bleeding.  People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death.  Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

    About AIHA
    AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

    About R8351
    The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.

    About R5521
    The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting protein kinase (RIP1). RIP1 is believed to play a critical role in necroptosis. Necroptosis is a form of regulated cell death where the rupturing of cells leads to the dispersion of their inner contents, which induces immune responses and enhances inflammation. In preclinical studies, R552 prevented joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage. The safety and efficacy of R552 has not been established by the FDA or any healthcare authority.

    Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
    Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

    Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

    About TAVALISSE
    Indication 
    TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

    Important Safety Information
    Warnings and Precautions

    • Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
    • Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
    • Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
    • Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
    • TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

    Drug Interactions

    • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
    • It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
    • Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
    • Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

    Adverse Reactions

    • Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
    • Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

    Please see www.TAVALISSE.com for full Prescribing Information.

    To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

    TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc. 

    About Rigel (www.rigel.com)

    Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

    Forward Looking Statements
    This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; Rigel's ability to broaden its pipeline of assets targeting immune-mediated diseases; Rigel's regulatory and collaborative efforts in Europe, Japan, and Canada to make fostamatinib available to ITP patients globally; the utility of fostamatinib in other indications, including warm autoimmune hemolytic anemia and other indications; Rigel's ability to achieve development and commercial milestones; the sufficiency of Rigel's cash, cash equivalents and short-term investments and the timing of its current cash runway; and the design, timing and results of Rigel's clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned", "will", "may", "expects", "anticipates", "estimates", "hopes", "believes" and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended June 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email:  

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

















    Three Months Ended September 30,


    Nine Months Ended September 30,



    2019

    2018


    2019

    2018



    (unaudited)








    Revenues:








    Product sales, net

    $

    11,716

    $

    4,865


    $

    29,943

    $

    6,652


    Contract revenues from collaborations 

    9,141


    13,945


    Total revenues

    20,857

    4,865


    43,888

    6,652








    Costs and expenses:







    Cost of product sales

    310

    69


    728

    99


    Research and development (see Note A)  

    14,463

    11,097


    38,638

    33,136


    Selling, general and administrative (see Note A)

    18,121

    18,069


    56,276

    48,632


         Total costs and expenses

    32,894

    29,235


    95,642

    81,867

    Loss from operations 

    (12,037)

    (24,370)


    (51,754)

    (75,215)

    Interest income 

    555

    604


    2,068

    1,507

    Interest expense

    (8)

    -


    (8)

    -

    Net loss


    $

    (11,490)

    $

    (23,766)


    $

    (49,694)

    $

    (73,708)








    Net loss per share, basic and diluted

    $

    (0.07)

    $

    (0.14)


    $

    (0.30)

    $

    (0.47)








    Weighted-average shares used in computing net loss per share, basic and diluted

    167,609

    166,464


    167,326

    158,456















    Note A














    Stock-based compensation expense included in:







    Selling, general and administrative

    $

    1,611

    $

    2,194


    $

    5,519

    $

    3,913


    Research and development

    487

    801


    2,185

    1,734



    $

    2,098

    $

    2,995


    $

    7,704

    $

    5,647
















    SUMMARY BALANCE SHEET DATA





    (in thousands)













    September 30,

    December 31,






    2019

    2018 (1)






     (unaudited) 






    Cash, cash equivalents and short-term investments 

    $

    107,480

    $

    128,537





    Total assets 

    156,061

    139,109





    Stockholders' equity

    68,911

    109,877