1. SOUTH SAN FRANCISCO, Calif., Sept. 2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, and Dean Schorno, the company's chief financial officer, will participate in the following virtual investor conferences in September:

    Citi's 16th Annual Biopharma Conference (September 8-10, 2021)

    • Raul Rodriguez will participate in a panel discussion entitled: "Sickle Cell, Beta-Thal, ITP & PKD - Measuring Industry Progress in Benign Hematology" on Friday, September 10th at 12:30 p.m. ET.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    • Dean Schorno will present a company overview, which will be available for on-demand viewing…

    SOUTH SAN FRANCISCO, Calif., Sept. 2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that Raul Rodriguez, the company's president and chief executive officer, and Dean Schorno, the company's chief financial officer, will participate in the following virtual investor conferences in September:

    Citi's 16th Annual Biopharma Conference (September 8-10, 2021)

    • Raul Rodriguez will participate in a panel discussion entitled: "Sickle Cell, Beta-Thal, ITP & PKD - Measuring Industry Progress in Benign Hematology" on Friday, September 10th at 12:30 p.m. ET.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    • Dean Schorno will present a company overview, which will be available for on-demand viewing for conference attendees starting on Monday, September 13th at 7:00 a.m. ET.

    Cantor Fitzgerald Global Healthcare Conference (September 27-30, 2021)

    • Raul Rodriguez will present a company overview on Tuesday, September 28th at 4:40 p.m. ET.

    To access the live webcast of the Citi Annual Biopharma Conference panel and the Cantor Fitzgerald Global Healthcare Conference presentation, 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. 

    Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with COVID-191; an NIH/NHLBI-sponsored Phase 3 ACTIV-4 Host Tissue Study for the treatment of COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn

    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 Contact:

    Jodi Sievers

    Rigel Pharmaceuticals, Inc.

    Phone: 650.624.1232

    Email: ir@rigel.com

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  2. SOUTH SAN FRANCISCO, Calif., Sept. 1, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced the publication of results from a Phase 2 clinical trial evaluating the safety of fostamatinib for the treatment of hospitalized patients with COVID-19, in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America. The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System.

    "As cases of COVID continue to surge across the world, improved therapies for patients hospitalized with COVID-19 are urgently needed," said Richard Childs, M.D., Clinical Director of the NHLBI at the…

    SOUTH SAN FRANCISCO, Calif., Sept. 1, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced the publication of results from a Phase 2 clinical trial evaluating the safety of fostamatinib for the treatment of hospitalized patients with COVID-19, in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America. The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System.

    "As cases of COVID continue to surge across the world, improved therapies for patients hospitalized with COVID-19 are urgently needed," said Richard Childs, M.D., Clinical Director of the NHLBI at the NIH. "We are encouraged to see that for COVID-19 patients requiring hospitalization, fostamatinib in combination with the standard of care was shown to be well tolerated in the study. Patients treated with fostamatinib not only had less severe adverse events, but were observed to have improved clinical outcomes compared to those receiving placebo and standard of care."

    The results from the 59 patient Phase 2 trial demonstrated that the addition of fostamatinib to standard of care (SOC), which included the antiviral remdesivir and the steroid dexamethasone, was well tolerated and associated with clinically meaningful improvement in clinical outcomes in hospitalized COVID-19 patients who required supplemental oxygen. While the study was not powered to test clinical efficacy, numerous prespecified secondary endpoints consistently favored fostamatinib, including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU, suggesting that fostamatinib may provide an additional therapeutic benefit compared to current SOC alone.

    "It's reassuring to see that fostamatinib demonstrated a consistently well-tolerated safety profile for hospitalized patients with COVID-19 in this trial," said Jeffrey R. Strich, M.D., principal investigator of the study and a physician at the NIH Clinical Center. "Additional studies are needed to confirm the efficacy findings and show how fostamatinib may address the dysregulated immune response observed in COVID-19 patients."

    Results were published online in a manuscript titled "Fostamatinib for the treatment of hospitalized adults with COVD-19, A randomized trial" and can be accessed here: https://doi.org/10.1093/cid/ciab732.

    Key findings within the fostamatinib Phase 2 trial include:

    • The study met the primary endpoint showing fostamatinib did not increase the incidence of serious adverse events (SAEs) compared with placebo.
    • The overall incidence of SAEs by Day 29 was approximately 50% less in the fostamatinib group (10.5%) compared with the placebo group (22.0%) (p=0.2) . The most frequent SAE reported by Day 29 was hypoxia, occurring in 1 patient receiving fostamatinib and 3 patients receiving placebo.
    • At Day 29, in the overall population there were zero deaths in the fostamatinib group compared to 3 in the placebo group (p=0.07). In more severe patients (ordinal scale 6 or 7), the difference was 0/19 patients in the fostamatinib group compared to 3/17 patients in the placebo group (p=0.049).
    • There were 4 intubated patients in the trial on mechanical ventilation (ordinal scale 7) upon enrollment with 2 patients randomized to each treatment group. Both patients in the fostamatinib group were extubated and discharged from the hospital, while both patients in the placebo group deceased.
    • The median number of days in the ICU was reduced by 4 days, from 7 days (IQR* 2-10) in the placebo group to 3 days (IQR 2-5) in the fostamatinib group (p=0.07).
    • The median number of days on oxygen was 8 (IQR 5-10) in the fostamatinib group compared to 20 (IQR 14-27) in the placebo group (p=0.2). The difference was even greater in more severe patients with the fostamatinib group at 10 days compared to placebo at 28 days (p=0.027).
    • At Day 15, 65.5% of patients were free of supplemental oxygen in the fostamatinib group compared to 39.9% in the placebo group (p=0.08). In more severe patients, the difference was 57.9% compared to 20% (p=0.016).
    • Fostamatinib was superior to placebo in accelerating improvement in clinical status from baseline by Day 15 (mean change -3.6 + 0.3 vs. -2.6 + 0.4; p=0.035) using ordinal scale assessments.
    • The median time to recovery was 8 days in both groups. The greatest benefits were observed in more severe patients where the median time to recovery was reduced from 13 days (IQR 11-19) in the placebo group to 10 days (IQR 6-13) in the fostamatinib group.
    • Despite general SOC use of both steroids and remdesivir in all 59 patients, there was a consistently greater reduction in NETosis and other inflammatory biomarkers (CRP, Ferritin, D-Dimer, Fibrinogen) in the fostamatinib group compared to the placebo group.

    *IQR = Interquartile Range, is the range of the first and third quartiles of the range as a measure of spread.

    "With the need remaining so great, we are very pleased with the growing body of evidence that suggests fostamatinib may provide clinical benefit for those patients hospitalized with COVID-19," said Raul Rodriguez, president and CEO of Rigel. "Our larger Phase 3 clinical trial in COVID-19, which we expect to complete later this year, will provide us with further understanding of the safety and efficacy of fostamatinib and its potential as a new therapy for these patients."

    Phase 2 Clinical Trial Design

    The Phase 2 double-blind, placebo-controlled clinical trial sponsored by the NHLBI, part of the NIH, in collaboration with Inova Health System, enrolled fifty-nine hospitalized patients with COVID-19 who were a 5 to 7 on the 8-point ordinal scale (requiring supplemental oxygen via nasal cannula or non-invasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation). Patients were randomly assigned to one of two cohorts: fostamatinib plus SOC and matched placebo plus SOC (1:1). Treatment was administered orally twice daily for 14 days, with a follow-up period through day 60. The primary outcome was the cumulative incidence of SAEs by Day 29. Notably, all patients received dexamethasone (or other steroid) and remdesivir.

    About Clinical Infectious Diseases  

    Clinical Infectious Diseases is a leading journal in the field of infectious diseases with a broad international readership. The journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America. Learn more at https://academic.oup.com/cid.

    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. 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 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase 3 ACTIV-4 Host Tissue Study for the treatment of COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn.

    Please see www.TAVALISSEUSPI.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 press release and other publicly available documents, including the documents incorporated herein by reference, contain " forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include statements relating to, among other things, the continuing need for therapies to treat the health impacts and complications from COVID-19; the plans of Rigel and other parties to complete further confirmatory studies of fostamatinib's safety and efficacy in COVID-19 patients; and Rigel's plans to seek regulatory and marketing approvals of fostamatinib's use for treating COVID-19 patients. Forward-looking statements can be identified by words such as "plan", "potential", "may", "expects", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions, and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. 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 whether there is an ongoing need for COVID-19 therapies; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that fostamatinib clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib 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 June 30, 2021. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

    Contacts:

    For Investors

    Jodi Sievers – Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

    For Media

    Emily Correia – Syneos Health

    Phone: 508.314.3157

    Email: emily.correia@syneoshealth.com

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  3. SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

    "With new virus variants spreading and vaccination rates plateauing…

    SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

    "With new virus variants spreading and vaccination rates plateauing, there remains a need for therapies that can improve outcomes for hospitalized patients, particularly patients suffering from hyperinflammatory COVID-19-related complications," said Raul Rodriguez, president and CEO of Rigel. "The Rigel team continues to focus on enrolling our Phase 3 clinical trial, which we anticipate completing later this year, and we look forward to providing further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, we plan to resubmit our EUA application with this additional data."

    Fostamatinib Clinical Development Program in COVID-19

    The broader clinical development program for fostamatinib is comprised of three ongoing studies and a recently completed Phase 2 study. These studies are evaluating a wide range of hospitalized patients, including those not on oxygen therapy, who are experiencing mild to severe COVID-19-related complications:

    • Rigel-led Phase 3 Trial. This ongoing 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 study will enroll ~308 evaluable patients to either fostamatinib plus SOC or matched placebo plus SOC (1:1). The primary endpoint of this study is the proportion of patients who progress to severe/critical disease within 29 days. The study has enrolled ~176 patients as of August 12, 2021, and enrollment is expected to be complete by year-end. More detail on the study can be found on clinicaltrials.gov: NCT04629703.
    • ACTIV-4 Host Tissue Phase 3 Trial. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) study, initiated and funded by the National Heart Lung and Blood Institute (NHLBI), part of the National Institutes of Health, is a multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. The Master Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Each active arm will include approximately 300 patients. Eligible participants will include patients hospitalized for COVID-19 with laboratory-confirmed SARS-CoV-2 infection on oxygen therapy. The primary outcome is oxygen-free days through day 28. Secondary outcomes include hospital mortality, use of mechanical ventilation, and WHO scale scores. The study enrolled its first patient on July 22, 2021. More detail on the study can be found on clinicaltrials.gov: NCT04924660.
    • Imperial College of London IST. The Imperial College London Investigator-Sponsored Trial (IST) is a two-stage, open-label, controlled clinical trial of patients randomized (1:1:1) to fostamatinib, ruxolitinib, or SOC. The primary objective will be to determine the efficacy of fostamatinib and the efficacy of ruxolitinib compared to SOC to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia. Rigel is providing support for this trial along with Novartis.  More detail on the study can be found on clinicaltrials.gov: NCT04581954.
    • NIH/NHLBI-sponsored Phase 2 Trial. This randomized, double-blind, placebo-controlled study, which has been completed, evaluated the safety of fostamatinib plus SOC and matched placebo plus SOC (1:1) in hospitalized patients with COVID-19 requiring supplemental oxygen. The primary endpoint was the cumulative incidence of serious adverse events (SAEs) by Day 29. As previously announced, the study met its primary endpoint of safety and provided evidence of broad and consistent improvement in numerous secondary endpoints including mortality, time to sustained recovery, change in ordinal scale assessment, number of days on oxygen, and number of days in the ICU. Results from this study have been submitted for publication in a peer-reviewed medical journal. More details on the study can be found on clinicaltrials.gov: NCT04579393.

    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

    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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    For more information on Rigel's comprehensive clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19

    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. 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 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)7; a Phase 3 clinical trial for the treatment of hospitalized high-risk patients with COVID-197; an NIH/NHLBI-sponsored Phase 3 clinical trial (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn.

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

    1. Berlin DA, Gulick RM, and Martinez FJ. Severe Covid-19. N Engl J Med 2020.  DOI: https://doi.org/10.1056/NEJMcp2009575

    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. High titers and low fucosylation of early human anti–SARS-CoV-2 IgG promote inflammation by alveolar macrophages. Science Translational Medicine 02 Jun 2021. DOI: https://www.doi.org/10.1126/scitranslmed.abf8654

    4. Sung P-S and Hsieh S-L. CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Frontiers in Immunology December 6, 2019. DOI: https://doi.org/10.3389/fimmu.2019.02867

    5. Bye AP et al. Aberrant glycosylation of anti-SARS-CoV-2 IgG is a pro-thrombotic stimulus for platelets. BioRxiv March 26, 2021. DOI: https://doi.org/10.1101/2021.03.26.437014

    6. Strich J et al. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. Journal of Infectious Disease March 15, 2021. DOI: https://doi.org/10.1093/infdis/jiaa789

    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 COVID-19 clinical program, including its use of fostamatinib to treat hospitalized patients suffering from COVID-19; the clinical development program for fostamatinib, including the Rigel-led Phase 3 Trial, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) study and the Imperial College of London Investigator-Sponsored Trial; and Rigel's recently completed Phase 2 study on fostamatinib. 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 quarter ended June 30, 2021. 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.

    Contact for Investors & Media

    Jodi Sievers – Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

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  4. SOUTH SAN FRANCISCO, Calif., Aug. 3, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the second quarter ended June 30, 2021, 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.

    "As we begin the second half of 2021, Rigel is well-positioned to execute on several key milestones that have the potential to be important inflection points for the company," said Raul Rodriguez, Rigel's president and CEO. "TAVALISSE sales are growing as we are able to access more clinicians in-person, and we are expanding our commercial team to allow us to have…

    SOUTH SAN FRANCISCO, Calif., Aug. 3, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the second quarter ended June 30, 2021, 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.

    "As we begin the second half of 2021, Rigel is well-positioned to execute on several key milestones that have the potential to be important inflection points for the company," said Raul Rodriguez, Rigel's president and CEO. "TAVALISSE sales are growing as we are able to access more clinicians in-person, and we are expanding our commercial team to allow us to have a greater impact as physicians and patients continue to return to the clinic. Our pipeline programs continue to advance as we wait for a decision on our EUA, with our own Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients rapidly enrolling and our Phase 3 clinical trial of fostamatinib in wAIHA nearing its enrollment goal," continued Mr. Rodriguez.

    Business Update

    In July, Rigel initiated expansion of its sales force from 39 to 55 territories. Recruiting is underway and it is expected that the team will be fully trained and in the field by the end of September.

    In June, Rigel announced that fostamatinib had been selected as part of the National Institutes of Health (NIH) sponsored ACTIV-4 Host Tissue trial. Recruiting is underway and the first patient has been enrolled in the multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients.

    In late-May, Rigel submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for fostamatinib in hospitalized patients diagnosed with COVID-19. The request included data from a NHLBI/NIH-sponsored Phase 2 study, which reported positive topline results in April.

    Rigel's Phase 3 clinical trial evaluating fostamatinib in high-risk patients hospitalized with COVID-19 has enrolled ~150 of the targeted 308 patients, and expects to complete enrollment by year-end 2021.

    Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in patients with warm autoimmune hemolytic anemia (wAIHA), has enrolled 80 of the targeted 90 patients. If approved, TAVALISSE has the potential to be the first to market therapy for patients with wAIHA.

    During the quarter, Rigel received feedback from the FDA supporting its proposed clinical program to evaluate R289, a pro-drug formulation of R835, in low-risk myelodysplastic syndromes (MDS). Planning is now underway on the Phase 1/2 clinical trial.

    In June, Rigel entered into a research collaboration with MD Anderson Cancer Center to evaluate Rigel's novel IRAK1/4 inhibitors in a series of preclinical studies of MDS and chronic myelomonocytic leukemia (CMML). The translational research generated from these studies will add to the body of data generated to date on R835 and R289 and further elucidate the therapeutic potential of targeting deregulated innate immune signaling in MDS and CMML.

    Financial Update

    For the second quarter of 2021, Rigel reported net loss of $13.8 million, or $0.08 per basic and diluted share, compared to a net loss of $17.6 million, or $0.10 per basic and diluted share, for the same period of 2020.

    In the second quarter of 2021, total revenues were $26.3 million, consisting of $17.1 million in TAVALISSE net product sales, $3.7 million in contract revenues from collaborations, and $5.5 million in government contract revenue. TAVALISSE net product sales of $17.1 million in the second quarter of 2021 increased by 14% from $15.0 million for the same period of 2020.

    Contract revenues from collaborations of $3.7 million for the second quarter of 2021 consisted of $3.3 million in revenue related to Rigel's license agreement with Lilly, and $0.4 million in revenue related to the performance of certain research and development services pursuant to its collaboration agreement with Grifols. Government contract revenue was related to the income recognized pursuant to the agreement Rigel entered in January 2021 with the U.S. Department of Defense (DOD) to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.

    Rigel reported total costs and expenses of $39.3 million in the second quarter of 2021, compared to $33.4 million for the same period in 2020. The increase in costs and expenses was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to Rigel's various on-going clinical studies.

    For the six months ended June 30, 2021, Rigel reported net income of $25.7 million, or $0.15 per basic and diluted share, compared to a net income of $3.7 million, or $0.02 per basic and diluted share, for the same period of 2020.

    Rigel reported total revenues of $107.3 million for the six months ended June 30, 2021, consisting of $29.4 million in TAVALISSE net product sales, $69.4 million in contract revenues from collaborations, and $8.5 million in government contract revenues. TAVALISSE net product sales of $29.4 million increased by 6% from $27.7 million for the same period of 2020. Contract revenues from collaborations of $69.4 million for the six months ended June 30, 2021, consisted of $63.9 million in revenue related to Rigel's license agreement with Lilly, $4.0 million in revenue related to the grant of a non-exclusive license of a certain patent to an unrelated third-party company, and $1.4 million in revenue for the delivery of drug supply, as well as performance of certain research and development services pursuant to its collaboration agreement with Grifols. Government contract revenue of $8.5 million for the six months ended June 30, 2021, was related to the income recognized pursuant to the agreement Rigel entered in January 2021 with the DOD to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.

    Total costs and expenses for the six months ended June 30, 2021, were $78.6 million, compared to $68.1 million for the same period in 2020. The increase in costs and expenses was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to Rigel's various on-going clinical studies.

    As of June 30, 2021, Rigel had cash, cash equivalents, and short-term investments of $153.4 million, compared to $57.3 million as of December 31, 2020.

    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 destroy 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 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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    For more information on Rigel's comprehensive clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19

    About RIP1 Inhibitor, R552

    Investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting serine/threonine-protein kinase 1 (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 IRAK1/4 Inhibitor R835/R289

    Investigational candidates, R835 and its pro-drug, R289 are orally available, potent and selective inhibitors of both IRAK1 and IRAK4. In clinical and preclinical studies, R835 has been shown 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 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 or its pro-drug, R289, have 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.TAVALISSEUSPI.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.  

    Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)7; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with COVID-197; an NIH/NHLBI-sponsored Phase 3 clinical trial (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed. 

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn

    1. Berlin DA, Gulick RM, and Martinez FJ. Severe Covid-19. N Engl J Med 2020.  DOI: https://doi.org/10.1056/NEJMcp2009575 

    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. High titers and low fucosylation of early human anti–SARS-CoV-2 IgG promote inflammation by alveolar macrophages. Science Translational Medicine 02 Jun 2021. DOI: https://www.doi.org/10.1126/scitranslmed.abf8654 

    4. Sung P-S and Hsieh S-L. CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Frontiers in Immunology December 6, 2019. DOI: https://doi.org/10.3389/fimmu.2019.02867  

    5. Strich J et al. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. Journal of Infectious Disease March 15, 2021. DOI: https://doi.org/10.1093/infdis/jiaa789 

    6. Bye AP et al. Aberrant glycosylation of anti-SARS-CoV-2 IgG is a pro-thrombotic stimulus for platelets. BioRxiv March 26, 2021. DOI: https://doi.org/10.1101/2021.03.26.437014 

    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. and TAVLESSE in Europe, including its ability to expand its sales force; expectations related to the potential and market opportunity for fostamatinib as a COVID-19 therapeutic; Rigel's ability to further develop its clinical stage and early-stage product candidates and programs; 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 quarter ended March 31, 2021. 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 for Investors & Media:

    Jodi Sievers - Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

    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,





    2021



    2020



    2021



    2020





    (unaudited)

    Revenues:

















    Product sales, net

    $             17,053



    $             14,974



    $             29,429



    $             27,654



    Contract revenues from collaborations 

    3,713



    1,047



    69,355



    44,128



    Government contract

    5,500



    -



    8,500



    -



    Total revenues

    26,266



    16,021



    107,284



    71,782

    Costs and expenses:

















    Cost of product sales

    129



    279



    445



    434



    Research and development (see Note A)  

    16,807



    14,214



    33,633



    30,363



    Selling, general and administrative (see Note A)

    22,378



    18,920



    44,499



    37,350



         Total costs and expenses

    39,314



    33,413



    78,577



    68,147

    Income from operations 

    (13,048)



    (17,392)



    28,707



    3,635



    Interest income 

    16



    169



    17



    527



    Interest expense

    (1,759)



    (353)



    (2,244)



    (495)

    Income before income taxes

    (14,791)



    (17,576)



    26,480



    3,667

    Provision for (Benefit from) income taxes

    (970)



    -



    801



    -

    Net income

    $           (13,821)



    $           (17,576)



    $             25,679



    $               3,667



















    Net loss per share, basic and diluted

















    Basic

    $               (0.08)



    $               (0.10)



    $                 0.15



    $                 0.02



    Diluted

    $               (0.08)



    $               (0.10)



    $                 0.15



    $                 0.02



















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















    Basic

    170,192



    168,570



    169,997



    168,519



    Diluted

    170,192



    168,570



    175,912



    168,525





































    Note A















    Stock-based compensation expense included in:

















    Selling, general and administrative

    $               1,772



    $               1,299



    $               3,825



    $               2,629



    Research and development

    534



    458



    1,120



    1,152





    $               2,306



    $               1,757



    $               4,945



    $               3,781







































    SUMMARY BALANCE SHEET DATA











    (in thousands)































    June 30,



    December 31,













    2021



    2020 (1)













     (unaudited) 













    Cash, cash equivalents and short-term investments 

    $           153,387



    $             57,327









    Total assets 

    201,598



    110,378









    Stockholders' equity

    68,110



    34,026









    (1)

    Derived from audited financial statements

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-reports-second-quarter-2021-financial-results-and-provides-business-update-301347451.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  5. SOUTH SAN FRANCISCO, Calif., July 27, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 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…

    SOUTH SAN FRANCISCO, Calif., July 27, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its second quarter 2021 financial results after market close on Tuesday, August 3, 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 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial for the treatment of COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn

    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 Contact:

    Jodi Sievers

    Rigel Pharmaceuticals, Inc.

    Phone: 650.624.1232

    Email: ir@rigel.com

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  6. SOUTH SAN FRANCISCO, Calif., July 14, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that data from its clinical development program for TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be highlighted in two presentations at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, taking place online from July 17 – 21, 2021.

    "For patients who remain on TAVALISSE for a year or more, we found that their initial response was not the final response and platelet counts continued to increase over time," said Wolfgang Dummer, MD, PhD, chief medical officer for Rigel. "This is due to TAVALISSE's mechanism of action, SYK inhibition, which blocks the autoimmune response that…

    SOUTH SAN FRANCISCO, Calif., July 14, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that data from its clinical development program for TAVALISSE® (fostamatinib disodium hexahydrate) tablets will be highlighted in two presentations at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, taking place online from July 17 – 21, 2021.

    "For patients who remain on TAVALISSE for a year or more, we found that their initial response was not the final response and platelet counts continued to increase over time," said Wolfgang Dummer, MD, PhD, chief medical officer for Rigel. "This is due to TAVALISSE's mechanism of action, SYK inhibition, which blocks the autoimmune response that leads to platelet destruction, allowing the patient's platelet count to build in a natural and gradual way."

    "The post-hoc analyses that will be presented at ISTH show that treatment with TAVALISSE results in continuously increasing platelet counts over the first year of treatment, highlighting the potential benefit for ITP patients of longer-term treatment," said Raul Rodriguez, Rigel's president and CEO. "By evaluating these patient groups, we are able to provide clinicians with further insight into how duration of therapy and treatment in earlier lines of therapy can potentially impact clinical outcomes."

    Fostamatinib is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the autoimmune process that leads to platelet destruction in immune thrombocytopenia (ITP). 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.

    All ePosters will be made available online during the Poster Networking Session on the conference website on Saturday, July 17, 2021, at 4:00 p.m. Eastern Time.

    Abstract Presentation Number: PB0815

    Title
    : Time Course of Response to Fostamatinib, an Oral Spleen Tyrosine Kinase (SYK) Inhibitor for the Treatment of Immune Thrombocytopenia (ITP)

    Presenting Author: Michelle Sholzberg, MDCM, Division Head of Hematology-Oncology and the Medical Director of the Coagulation Laboratory at St. Michael's Hospital, Toronto

    In a post-hoc analysis of the Rigel FIT Phase 3 program, for the 58 patients treated for ≥1 year, clinical endpoints were assessed in 3-month increments over the first year:

    • Patients treated for ≥1 year, had a response rate (achieved a platelet count ≥50,000/µL) of 91% (53/58), 71% (41/58) within 12 weeks, with median platelet counts continuing to increase in each 3-month period of the first year of treatment.
    • Incidence of bleeding events and use of rescue therapy continually decreased in these 58 patients over the first year of treatment with fostamatinib.

    Abstract Presentation Number: PB0833

    Title:
     Treatment of Immune Thrombocytopenia (ITP) in the COVID-19 Era: Fostamatinib, an Oral Spleen Tyrosine Kinase (SYK) Inhibitor

    Presenting Authors: Nichola Cooper, Asad Charania, Alice Hart, Christine Ademokun, and Robert Numerof

    A review of safety and efficacy data from the fostamatinib Phase 3 program evaluated dosing and titration, incidence of infections, thrombocytosis and thrombosis, and the immune response to pathogens to assess the potential benefits of TAVALISSE for the unique challenges of treating ITP during the pandemic. Findings include:

    • A reduced need for office visits due to oral administration, easy titration, and low incidence of thrombocytosis.
    • Fostamatinib's unique mechanism of action provide increased hemostasis and may reduce the risk of thrombosis.
    • Fostamatinib is not an immunosuppressant drug.

    In addition to the poster presentations, Rigel is participating in a virtual symposium:

    Title: Role of Spleen Tyrosine Kinase (SYK) and SYK Inhibition in Disease Pathways

    Date and Time:
     Sunday, July 18, 2021, 12:30 - 1:30 p.m. ET

    Presenters:

    • Dr. Vadim Markovtsov – SYK in Human Biology and Disease Pathways
    • Dr. Nichola Cooper – Clinical Trials with SYK Inhibitors
    • Dr. Craig Kessler, Moderator

    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 about 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

    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 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial for the treatment of COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn.

    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 for ITP patients of longer-term treatment with TAVALISSE. 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 quarter ended March 31, 2021. 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.

    Contact for Investors & Media:

    Jodi Sievers - Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

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

     

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  7. SOUTH SAN FRANCISCO, Calif., June 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that fostamatinib, the Company's novel oral spleen tyrosine kinase (SYK) inhibitor, has been selected for a National Institutes of Health (NIH) ACTIV-4 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in hospitalized patients with COVID-19.

    The ACTIV-4 Host Tissue trial is a large, multi-site trial funded by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH and coordinated by Vanderbilt University Medical Center (VUMC). The trial is evaluating treatments, including fostamatinib, that aim to protect and heal host tissues in hospitalized patients with COVID-19.

    This study follows a recently completed…

    SOUTH SAN FRANCISCO, Calif., June 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that fostamatinib, the Company's novel oral spleen tyrosine kinase (SYK) inhibitor, has been selected for a National Institutes of Health (NIH) ACTIV-4 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in hospitalized patients with COVID-19.

    The ACTIV-4 Host Tissue trial is a large, multi-site trial funded by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH and coordinated by Vanderbilt University Medical Center (VUMC). The trial is evaluating treatments, including fostamatinib, that aim to protect and heal host tissues in hospitalized patients with COVID-19.

    This study follows a recently completed NHLBI/NIH-sponsored Phase 2 study (NCT04579393), with positive topline results, that evaluated fostamatinib in hospitalized adults with COVID-19. The study met its primary endpoint of safety and showed broad and consistent improvement in numerous efficacy endpoints including mortality, ordinal scale assessment, and number of days in the ICU. These data were submitted as part of a request for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for fostamatinib in hospitalized patients diagnosed with COVID-19. These data have also been submitted for publication in a peer-reviewed medical journal.

    "Despite welcome advances in some areas, COVID-19 and its variants will remain a real public health threat for the foreseeable future, particularly for those with pre-existing conditions," said Raul Rodriguez, Rigel's president and CEO. "The teams at the NIH and VUMC are ideally positioned to continue to advance clinical efforts for COVID-19 related lung injuries, including the study of fostamatinib's potential to treat and prevent conditions caused by an overactive immune system in COVID-19 patients," he added.

    "Fostamatinib will be the fourth arm of our ACTIV-4 Host Tissue trial. The drugs tested on this platform offer an opportunity to better understand both the central pathways of disease progression and better ways to protect and heal the host tissues damaged by COVID-19," said Dr. Sean P. Collins, MD, MSc, ACTIV-4 Host Tissue Principal Investigator and Professor of Emergency Medicine at VUMC.

    ACTIV-4 Host Tissue Phase 3 Clinical Study Design

    The Collaborative Network of Networks for Evaluating COVID-19 Therapeutic Strategies (CONNECTS) Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue) is a multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. The Master Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Each active arm will include approximately 300 patients. Eligible participants will include patients hospitalized for COVID-19 with laboratory confirmed SARS-CoV-2 infection on oxygen therapy. The primary outcome is oxygen free days through day 28. Secondary outcomes include hospital mortality, use of mechanical ventilation, and WHO scale scores. More detail on the study can be found on clinicaltrials.gov: NCT04924660.

    The study is part of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), initiated and funded by the NHLBI, part of the NIH. ACTIV is a public-private partnership that unites partners from government, industry, academic and non-profit organizations to prioritize and speed development of the most promising COVID-19 treatments.

    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 pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

    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. 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 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)7; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with mild-to-moderate COVID-197; and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System, was recently completed.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    For further information, visit www.rigel.com or follow us on Twitter or LinkedIn.

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

    1. Berlin DA, Gulick RM, and Martinez FJ. Severe Covid-19. N Engl J Med 2020.  DOI: https://doi.org/10.1056/NEJMcp2009575
    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 Hoepel W et al. High titers and low fucosylation of early human anti–SARS-CoV-2 IgG promote inflammation by alveolar macrophages. Science Translational Medicine 02 Jun 2021. DOI: https://www.doi.org/10.1126/scitranslmed.abf8654
    3. Sung P-S and Hsieh S-L. CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral Infections. Frontiers in Immunology December 6, 2019. DOI: https://doi.org/10.3389/fimmu.2019.02867  Strich J et al. Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic. Journal of Infectious Disease March 15, 2021. DOI: https://doi.org/10.1093/infdis/jiaa789
    4. Bye AP et al. Aberrant glycosylation of anti-SARS-CoV-2 IgG is a pro-thrombotic stimulus for platelets. BioRxiv March 26, 2021. DOI: https://doi.org/10.1101/2021.03.26.437014
    5. 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 further develop its clinical stage product candidates and fostamatinib's potential to treat and prevent conditions caused by COVID-19. 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 quarter ended March 31, 2021. 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.

    Contact for Investors & Media:

    Jodi Sievers - Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

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

     

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  8. SOUTH SAN FRANCISCO, Calif., May 26, 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 Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 1:00 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…

    SOUTH SAN FRANCISCO, Calif., May 26, 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 Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 1:00 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 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 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-191; an NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System; and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London.  

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo. 

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

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

    Rigel Contact: 

    Jodi Sievers  

    Phone: +1 (650)624-1232 

    Email: ir@rigel.com 

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

     

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  9. SOUTH SAN FRANCISCO, Calif., May 14, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it has appointed Alison L. Hannah, M.D. to its Board of Directors. Dr. Hannah brings over three decades of pharmaceutical industry experience to Rigel, including a deep knowledge of clinical development strategy in hematology and oncology with a focus on molecularly targeted therapies.

    "We are delighted to have Alison join our Board," said Raul Rodriguez, Rigel's president and CEO. "With her extensive expertise in areas of key focus for Rigel, including clinical development strategy and successful regulatory filings, she will provide valuable insights to our Board as we continue to advance and expand our hematology, immunology…

    SOUTH SAN FRANCISCO, Calif., May 14, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it has appointed Alison L. Hannah, M.D. to its Board of Directors. Dr. Hannah brings over three decades of pharmaceutical industry experience to Rigel, including a deep knowledge of clinical development strategy in hematology and oncology with a focus on molecularly targeted therapies.

    "We are delighted to have Alison join our Board," said Raul Rodriguez, Rigel's president and CEO. "With her extensive expertise in areas of key focus for Rigel, including clinical development strategy and successful regulatory filings, she will provide valuable insights to our Board as we continue to advance and expand our hematology, immunology, and oncology programs."

    Alison L. Hannah, M.D. currently serves as Chief Medical Officer for CytomX Therapeutics, a clinical-stage biopharmaceutical company developing conditionally activated therapies to treat cancer. Prior to joining CytomX, Dr. Hannah served as a consultant to nearly 30 pharmaceutical and biotechnology companies directing the development of investigational cancer therapies. In this capacity, Dr. Hannah has successfully filed over 40 regulatory applications for First-in-Human clinical testing and has played significant roles in the broad marketing approval of multiple anticancer therapeutics (including talazoparib, enzalutamide, defibrotide, carfilzomib, as well as tyrosine kinase inhibitors sunitinib and toceranib), including extensive experience interacting with global health and regulatory authorities. Earlier in her career, Dr. Hannah held the role of Senior Medical Director at SUGEN, Inc. (acquired by Pharmacia & Upjohn, now Pfizer) where she had oversight of clinical development, clinical operations, and pharmacovigilance, specializing in the development of tyrosine kinase inhibitors, including sunitinib (SUTENT) approved for the treatment of kidney cancer and imatinib-refractory gastrointestinal stromal tumors. Dr. Hannah began her career at Quintiles, a global contract research organization, where she specialized in overseeing early to registrational-stage oncology clinical trials. Dr. Hannah currently serves on the board of NeoGenomics, a publicly traded cancer diagnostic company. Dr. Hannah received her B.A. in biochemistry and immunology from Harvard University and her M.D. from the University of Saint Andrews.

    "I have been very impressed by Rigel's scientific approach and its ability to discover and develop a portfolio of unique therapies for patients suffering from hematologic diseases, cancer and autoimmune disorders," said Dr. Hannah. "I'm looking forward to collaborating with Rigel's management team and other members of its Board to provide strategic guidance as the company continues to advance its innovative product candidates through clinical trials with the goal of delivering them to patients in need." 

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

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

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

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

    Rigel Contact:

    Jodi Sievers

    Phone: +1 (650)624-1232

    Email: ir@rigel.com

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

     

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  10. SOUTH SAN FRANCISCO, Calif., May 5, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the first quarter ended March 31, 2021, 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 continued to make significant progress in achieving important corporate and clinical milestones in the first quarter, which is a true testament to the dedication of our team to bring meaningful treatment options to those patients who need them the most," said Raul Rodriguez, Rigel's president and CEO. "Following our recent announcement of positive topline data…

    SOUTH SAN FRANCISCO, Calif., May 5, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the first quarter ended March 31, 2021, 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 continued to make significant progress in achieving important corporate and clinical milestones in the first quarter, which is a true testament to the dedication of our team to bring meaningful treatment options to those patients who need them the most," said Raul Rodriguez, Rigel's president and CEO. "Following our recent announcement of positive topline data from the Phase 2 trial of fostamatinib in hospitalized patients with COVID-19 and our partnership with Eli Lilly for our RIP1 inhibitor program, we are excited by the prospects that the rest of 2021 holds for Rigel."

    Business Update

    In April 2021, Rigel reported positive topline data from the multi-center, Phase 2 clinical trial evaluating the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19. The trial met its primary endpoint of safety, and showed broad and consistent improvement in numerous efficacy endpoints including mortality, ordinal scale assessment, and number of days in the ICU. The trial was conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System. The NHLBI is expected to publish a full analysis of the trial data in a peer-reviewed journal. Rigel is discussing these results with health authorities, including the U.S. Food and Drug Administration (FDA), and intends to apply for Emergency Use Authorization (EUA) for fostamatinib for the treatment of hospitalized COVID-19 patients.

    Rigel's Phase 3 clinical trial to further evaluate fostamatinib in hospitalized patients with COVID-19 is currently enrolling. Rigel was awarded $16.5 million from the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to support this Phase 3 clinical trial. The study is designed to evaluate fostamatinib for prevention of progression to severe disease in hospitalized patients with COVID-19 without respiratory failure that have certain high-risk prognostic factors. This multi-center, double-blind, placebo-controlled study will randomly assign patients 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.  In addition, Rigel's COVID-19 program includes an investigator-sponsored trial currently being conducted by Imperial College London.

    Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in patients with warm autoimmune hemolytic anemia (wAIHA), has enrolled 72 of 90 patients as of May 5, 2021. If approved, TAVALISSE has the potential to be the first to market therapy for patients with wAIHA. The FDA has granted Fast Track designation as well as Orphan Drug designation to TAVALISSE for the treatment of wAIHA.

    In the first quarter of 2021, 1,599 bottles of TAVALISSE were shipped to patients and clinics, an increase of 14% year over year. Net product sales for the first quarter decreased 2% year over year to $12.4 million.  During the quarter, the company experienced typical first quarter reimbursement issues such as the resetting of co-pays and the Medicare donut hole, along with physician and patient access issues created by the COVID-19 pandemic. Incrementally, the company's net product sales were negatively impacted by a significant 235 bottle decrease in bottles remaining in its distribution channels compared to Q4 2020.

    In April 2021, Rigel received a $125 million upfront cash payment from its collaboration with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976. In February 2021, Rigel and Lilly entered into a global exclusive license agreement and strategic collaboration to develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIP1) inhibitor, for all indications including autoimmune and inflammatory diseases.  Rigel and Lilly are currently focused on the planning for the initiation of a Phase 2 clinical trial. Pursuant to the collaboration, Lilly will also lead all clinical development of central nervous system (CNS) penetrating RIP1 inhibitors. Rigel is eligible to receive up to an additional $835 million in potential development, regulatory and commercial milestone payments, as well as tiered royalties that will vary depending upon Rigel's clinical development investment.

    Rigel is also advancing the development of its IRAK1/4 program, where it intends to pursue both hematology/oncology and rare immune disease opportunities. Rigel has begun discussions with the FDA regarding initiating a Phase 2 clinical trial in low-risk myelodysplastic syndrome (MDS) and is also in discussions regarding academic medical collaborations in this indication. In rare immune diseases, the company is exploring opportunities including palmoplantar pustulosis (PPP), hidradenitis suppurativa (HS), and others.  

    Rigel's partner Kissei Pharmaceutical Co., Ltd. (Kissei) has completed enrollment of its Phase 3 clinical trial of fostamatinib in adult Japanese patients with chronic ITP. In October 2018, Rigel and Kissei entered into an exclusive agreement to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan, and the Republic of Korea.

    Financial Update

    For the first quarter of 2021, Rigel reported net income of $39.5 million, or $0.23 per basic share and $0.22 per diluted share, compared to net income of $21.2 million, or $0.13 per basic and diluted share, for the same period of 2020.

    In the first quarter of 2021, total revenues were $81.0 million, consisting of $12.4 million in TAVALISSE net product sales, $65.6 million in contract revenues from collaborations and $3.0 million in government contract revenue.

    Contract revenues from collaborations of $65.6 million for the first quarter of 2021 consisted of $60.6 million in revenue related to Rigel's license agreement with Lilly, $4.0 million in revenue related to the grant of non-exclusive license of a certain patent to an unrelated third-party company, and $1.0 million in revenue for the delivery of drug supply under its collaboration agreement with Grifols. Government contract revenue was related to the income that Rigel recognized pursuant to the agreement it entered into in January 2021 with the DOD to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.

    Rigel reported total costs and expenses of $39.3 million in the first quarter of 2021, compared to $34.7 million for the same period in 2020. The increase in costs and expenses was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to its ongoing Phase 3 clinical trial in hospitalized patients with COVID-19 and development of its IRAK 1/4 inhibitor program, partially offset by the decrease in research and development costs due to the completion of a Phase 1 clinical trial for its RIP1 inhibitor program.

    As of March 31, 2021, Rigel had cash, cash equivalents and short-term investments of $39.3 million, compared to $57.3 million as of December 31, 2020.  Cash, cash equivalents and short-term investments as of March 31, 2021, does not include the $125.0 million upfront payment received from Lilly in April 2021.

    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 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.

    For more information on Rigel's comprehensive clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19

    About R552

    The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting serine/threonine-protein kinase 1 (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 R835

    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 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. 

    Fostamatinib is currently being studied in a Phase 3 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)6; a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-196; an NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-19, in collaboration with Inova Health System; and a Phase 2 clinical trial for the treatment of COVID-19 being conducted by Imperial College London.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in 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, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's intention to apply for EUA for fostamatinib for the treatment of hospitalized COVID-19 patients; Rigel's ability to achieve development, regulatory and commercial milestone payments, as well as tiered royalties; expectations related to the market opportunity for fostamatinib as a COVID-19 therapeutic; Rigel's ability to further develop its clinical stage and early stage product candidates and programs; 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, 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.

    Investor Contact:

    Jodi Sievers - Rigel Pharmaceuticals

    Phone: 650.624.1232

    Email: ir@rigel.com

    Media Contact:

    Emily Correia - Syneos Health

    Phone: 508-314-3157

    Email: emily.correia@syneoshealth.com

     

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

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)





















    Three Months Ended March 31,





    2021

    2020





    (unaudited)









    Revenues:







    Product sales, net

    $     12,376

    $           12,680



    Contract revenues from collaborations 

    65,642

    43,081



    Government contract

    3,000



    Total revenues

    81,018

    55,761









    Costs and expenses:







    Cost of product sales

    316

    155



    Research and development (see Note A)  

    16,826

    16,149



    Selling, general and administrative (see Note A)

    22,121

    18,430



         Total costs and expenses

    39,263

    34,734









    Income from operations 

    41,755

    21,027



    Interest income 

    1

    358



    Interest expense

    (485)

    (142)

    Income before income taxes

    41,271

    21,243

    Provision for income taxes

    1,771

    -

    Net income

    $     39,500

    $           21,243









    Net loss per share, basic and diluted







    Basic

    $         0.23

    $               0.13



    Diluted

    $         0.22

    $               0.13









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







    Basic

    169,800

    168,469



    Diluted

    176,069

    168,568

















    Note A













    Stock-based compensation expense included in:







    Selling, general and administrative

    $       2,053

    $             1,330



    Research and development

    586

    694





    $       2,639

    $             2,024



















    SUMMARY BALANCE SHEET DATA



    (in thousands)













    March 31,

    December 31,





    2021

    2020 (1)











    Cash, cash equivalents and short-term investments 

    $     39,345

    $           57,327



    Total assets 

    215,993

    110,378



    Stockholders' equity

    78,298

    34,026









    (1)

    Derived from audited financial statements





     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-reports-first-quarter-2021-financial-results-and-provides-business-update-301284724.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  11. SOUTH SAN FRANCISCO, Calif., April 28, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its first quarter 2021 financial results after market close on Wednesday, May 5, 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…

    SOUTH SAN FRANCISCO, Calif., April 28, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it will report its first quarter 2021 financial results after market close on Wednesday, May 5, 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 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; an NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of hospitalized patients with COVID-191, in collaboration with Inova Health System; and a Phase 2 clinical 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 patients with COVID-19.

    Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in 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 Contact:

    Jodi Sievers

    Rigel Pharmaceuticals, Inc.

    Phone: 650.624.1232

    Email: ir@rigel.com

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  12. SOUTH SAN FRANCISCO, Calif., April 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19.

    The trial, being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System, met its primary endpoint of safety. Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half.  By day 29, there were three SAEs in the fostamatinib plus standard of care (SOC) group of thirty patients compared to six SAEs…

    SOUTH SAN FRANCISCO, Calif., April 13, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced positive topline results from a multi-center, Phase 2 clinical trial to evaluate the safety of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized patients with COVID-19.

    The trial, being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System, met its primary endpoint of safety. Fostamatinib reduced the incidence of Serious Adverse Events (SAEs) by half.  By day 29, there were three SAEs in the fostamatinib plus standard of care (SOC) group of thirty patients compared to six SAEs in the placebo plus SOC group of twenty-nine patients (p=0.23). Of these, there was a reduction for the disease related SAE of hypoxia in the fostamatinib group compared to placebo (1 vs 3, respectively; p=0.29).

    "Despite the growing arsenal of vaccines gaining emergency use authorization, COVID-19 continues to spread and patients remain in need of effective therapies. We are extremely pleased with the outcome of this trial, which provides early indications of the potential positive impact of fostamatinib for patients with COVID-19," said Raul Rodriguez, president and CEO of Rigel. "These results are an important addition to the extensive accumulation of data evaluating fostamatinib in COVID-19, which also include the ongoing Phase 2 study with Imperial College London and our own Phase 3 clinical trial being conducted in the U.S. and Latin America."

    "Fostamatinib was shown to be well tolerated in hospitalized patients with COVID-19 on oxygen. Taken altogether, the results of this trial suggest fostamatinib may be a useful addition to improve the outcome of severe and critically ill COVID-19 patients who are at the highest risk of death despite treatment with the best conventional therapies under the current standard of care (including remdesivir and steroids)," said Wolfgang Dummer, M.D., Ph.D., Rigel's Chief Medical Officer. "Consistent with the observed clinical outcomes, we are encouraged to see that in patients receiving fostamatinib there was a more rapid decline in a number of inflammatory biomarkers, that have previously been shown to be associated with the course of COVID-19 disease, compared to those receiving placebo."

    Key findings from the Phase 2 clinical data readout include:

    • At Day 29, in the overall population there were zero deaths in the fostamatinib group of thirty patients compared to three deaths in the placebo group of twenty-nine patients (p=0.07). In more severe patients, those with an ordinal scale assessment of 6 or 7, the difference was zero of nineteen patients compared to three of seventeen patients (p=0.049), respectively.
    • There were four intubated patients in the trial on mechanical ventilation (ordinal scale 7) with two patients randomized to each treatment group. Both patients in the fostamatinib group improved within 7 days and came off the ventilator, while both patients in the placebo group deceased.
    • Fostamatinib was superior to placebo in accelerating improvement in clinical status by day 15 (mean change -3.6 compared to -2.6, p=0.035) and by day 29 (mean change -4.2 compared to -3.3, p=0.12) using ordinal scale assessments.
    • The median number of days in the ICU was reduced by 4 days, from 7 days in the placebo group to 3 days in the fostamatinib group (p=0.07).
    • Despite general SOC use of both steroids and remdesivir in all 59 patients, there was a consistently greater reduction in NETosis and other inflammatory biomarkers (CRP, Ferritin, D-Dimer, Fibrinogen) in the fostamatinib group as compared to the placebo group.

    Investigators will conduct full and detailed analyses in the coming weeks.

    Based on these data, Rigel plans to discuss the potential for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) of fostamatinib as a treatment for hospitalized patients with COVID-19.  Fostamatinib, marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).

    Phase 2 Clinical Trial Design

    This is a double-blind, placebo-controlled Phase 2 clinical trial sponsored by the NHLBI, part of the NIH, in collaboration with Inova Health System. Fifty-nine hospitalized patients with COVID-19 who were 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) were randomly assigned to one of two cohorts: fostamatinib plus SOC or matched placebo plus SOC (1:1). Treatment was administered orally twice daily for 14 days, with a follow-up period through day 60. Notably, all patients received dexamethasone as well as remdesivir.

    For more information on Rigel's comprehensive clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19

    Conference Call and Webcast with Slides Today at 8:00 am Eastern Time 

    Rigel will hold a live conference call and webcast today to discuss the Phase 2 trial results at 8:00 am Eastern Time (5:00 am 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 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 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)6; an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-196 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 its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.

    Please see www.TAVALISSE.com for 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 ability to improve the outcome of all COVID-19 patients by the use of fostamatinib; the continuing need for effective therapies for COVID-19 patients; Rigel's plans for the further investigation of fostamatinib in COVID-19 patients; as well as Rigel's plans to seek emergency use authorization for fostamatinib for the treatment of COVID-19. 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 that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib 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, 2020 and subsequent filings. 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: ir@rigel.com

    Rigel Media Contact:

    Phone: 508-314-3157

    Email: emily.correia@syneoshealth.com

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  13. SOUTH SAN FRANCISCO, Calif., April 7, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the successful closing of its license agreement with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976. Rigel and Lilly entered 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 penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

    The agreement…

    SOUTH SAN FRANCISCO, Calif., April 7, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the successful closing of its license agreement with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976. Rigel and Lilly entered 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 penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

    The agreement is effective as of March 27, 2021 and Rigel has received the $125 million upfront cash payment due under the terms of the agreement from Lilly. Additional details about the collaboration can be found in Rigel's Form 8-K filed with the Securities and Exchange Commission on February 18, 2021.

    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 its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in 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.

    Rigel Investor Contact: 

    Phone: 650.624.1232

    Email: ir@rigel.com

    Rigel Media Contact:

    Phone: 508-314-3157

    Email: emily.correia@syneoshealth.com

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  14. SOUTH SAN FRANCISCO, Calif., March 11, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the completion of patient enrollment in a multi-center Phase 2 clinical 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 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).

    The Phase 2 clinical trial is…

    SOUTH SAN FRANCISCO, Calif., March 11, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced the completion of patient enrollment in a multi-center Phase 2 clinical 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 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).

    The Phase 2 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. 

    This is a double-blind, placebo-controlled Phase 2 clinical trial that randomly assigned fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1) to 58 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 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. The NHLBI and Rigel expect to report topline data from this clinical trial in April 2021.

    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.

    Fostamatinib is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)6; an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-196 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 its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in 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 expectations on timing to report topline data from the Phase 2 trial, and the potential clinical benefit of fostamatinib for the treatment of hospitalized COVID-19 patients and the role of SYK inhibition in potentially improving outcomes for 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," "could," "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, unforeseen and foreseen delays in Rigel's ongoing clinical trials; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib or any other of Rigel's products and product candidates; risks that 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 misuse; 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, 2020 . In addition, the ongoing 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: ir@rigel.com

    Rigel Media Contact:

    Phone: 508-314-3157

    Email: emily.correia@syneoshealth.com

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  15. SOUTH SAN FRANCISCO, Calif., March 2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the fourth quarter and full year ended December 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.

    "Our team has shown its resilience as we continue to execute on our mission to serve patients who have diseases where few or no approved treatment options exist," said Raul Rodriguez, Rigel's president and CEO. "Despite the challenges brought on by 2020, we successfully expanded our global ITP reach and positioned ourselves for potential success…

    SOUTH SAN FRANCISCO, Calif., March 2, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today reported financial results for the fourth quarter and full year ended December 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.

    "Our team has shown its resilience as we continue to execute on our mission to serve patients who have diseases where few or no approved treatment options exist," said Raul Rodriguez, Rigel's president and CEO. "Despite the challenges brought on by 2020, we successfully expanded our global ITP reach and positioned ourselves for potential success in wAIHA, announced a major collaboration with Lilly to develop RIP1 inhibitors, and launched a comprehensive COVID-19 clinical program which has gained the support from the NIH, DOD, and several universities. Importantly, we also continued to explore opportunities in immunology, and more recently heme-onc, with our IRAK 1/4 inhibitor program." 

    Business Update

    In February 2021, Rigel and Eli Lilly (Lilly) announced a global strategic collaboration to co-develop and commercialize R552, Rigel's receptor-interacting serine/threonine-protein kinase 1 (RIP1) inhibitor, for all indications, including autoimmune and inflammatory diseases. In addition, Lilly will lead the development and commercialization of all RIP1 inhibitors in central nervous system (CNS) indications. Under the terms of the agreement, Lilly will pay an upfront cash payment to Rigel of $125 million and is eligible to receive up to $835 million in potential development, regulatory and commercial milestone payments, as well as tiered royalties that will vary depending upon Rigel's clinical development investment.

    Rigel launched a Phase 3 clinical trial to evaluate fostamatinib for the treatment of hospitalized COVID-19 patients. The Phase 3 trial is designed 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. 

    Rigel was awarded $16.5 million from 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 Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients.

    The Phase 2 clinical trial of fostamatinib in hospitalized COVID-19 patients sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System has currently enrolled 57 patients. This is a double-blind, placebo-controlled Phase 2 clinical trial that is randomly assigning fostamatinib plus standard of care (SOC) or matched placebo plus SOC (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). The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29. The NHLBI and Rigel expect to report topline data from this clinical trial in April 2021.

    Imperial College London's ongoing Phase 2 clinical trial of fostamatinib in hospitalized COVID-19 patients is a two-stage open label, controlled trial with patients randomized (1:1:1) to fostamatinib, ruxolitinib, or standard of care. The study has currently enrolled 106 patients. 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.

    Enrollment is progressing in Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia (wAIHA). The study has enrolled 66 of 90 patients targeted for enrollment. Rigel has reached agreement with the U.S. Food and Drug Administration (FDA) on the durable response measure for the primary efficacy endpoint of the study as well as the inclusion of additional secondary endpoints. The company recently announced that the FDA had granted Fast Track designation to TAVALISSE for the treatment of wAIHA. The FDA previously granted TAVALISSE Orphan Drug designation for this indication. If approved, TAVALISSE may be the first-to-market therapy for patients with wAIHA.

    Rigel continues to advance the development of its IRAK1/4 program, which includes R835, an orally available, potent and selective inhibitor that inhibits both IRAK1 and IRAK4. The company is currently identifying therapeutic opportunities in the areas of hematology/oncology and rare immunology diseases.

    In November 2020, Rigel and its partner Medison Pharma announced that Health Canada approved the new drug submission (NDS) for TAVALISSE for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to other treatments. Medison is also anticipating a decision on a New Drug Application (NDA) in Israel in Q2 2021. In July 2020, Rigel and its partner Grifols S.A. announced the launch of TAVLESSE in Germany and the United Kingdom following approval by the European Commission in January 2020. Currently, TAVALISSE is in a Phase 3b clinical trial in Japan with Rigel's partner Kissei. This trial is required for approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

    Financial Update

    For the fourth quarter of 2020, Rigel reported a net loss of $19.2 million, or $0.11 per share, compared to net loss of $17.2 million, or $0.10 per share, in the same period of 2019.

    In the fourth quarter of 2020, total revenues were $18.5 million, consisting of $17.8 million in TAVALISSE net product sales and $697,000 in contract revenues from collaborations. TAVALISSE net product sales of $17.8 million increased by 28% from $13.8 million in the fourth quarter of 2019. Contract revenues from collaborations of $697,000 for the fourth quarter of 2020 consisted 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.

    Rigel reported total costs and expenses of $37.3 million in the fourth quarter of 2020, compared to $32.7 million for the same period in 2019. The increase in costs and expenses was due to the increase in research and development costs primarily related to the continued work on Rigel's Phase 1 clinical trial in IRAK 1/4 inhibitor program, as well as its recently launched Phase 3 clinical trial for hospitalized COVID-19 patients, partially offset by the decrease in costs on Rigel's ongoing Phase 3 clinical trial in wAIHA.

    For the full year ended December 31, 2020, Rigel reported a net loss of $29.7 million, or $0.18 per share, compared to a net loss of $66.9 million, or $0.40 per share, for the same period of 2019.

    Rigel reported total revenues of $108.6 million for the year ended December 31, 2020, compared to $59.3 million in the same period of 2019.  Total revenues for the year ended December 31, 2020 consisted of $61.7 million in TAVALISSE net product sales and $46.9 million in contract revenues from collaborations. TAVALISSE net product sales of $61.7 million increased by 41% from $43.8 million in 2019. 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 the 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 year ended December 31, 2020, were $137.6 million, compared to $128.4 million, for the same period of 2019. The increase in total costs and expenses was primarily related to the increases in research and development costs due to the completion of Rigel's Phase 1 clinical trial in RIP1 inhibitor program, ongoing work on recently launched Phase 3 clinical trial for hospitalized COVID-19 patients, continued work on Rigel's Phase 1 clinical trial in IRAK 1/4 inhibitor program and ongoing Phase 3 clinical trials in wAIHA, as well as increases in personnel-related costs, partially offset by decreases in various third-party costs due to the COVID-19 pandemic.

    As of December 31, 2020, Rigel had cash, cash equivalents and short-term investments of $57.3 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 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 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 R5526

    The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting serine/threonine-protein kinase 1 (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 R8356

    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 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. 

    Fostamatinib is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)6; an NIH/NHLBI-sponsored Phase 2 trial for the treatment of hospitalized COVID-196 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 its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in 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, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's ability to achieve development, regulatory and commercial milestone payments, as well as tiered royalties; Rigel's expected operating results for the year 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 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, 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: ir@rigel.com

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

































    Three Months Ended December 31,



    Year Ended December 31,





    2020

    2019



    2020

    2019





    (unaudited)



















    Revenues:













    Product sales, net

    $             17,753

    $             13,829



    61,696

    $             43,772



    Contract revenues from collaborations 

    697

    1,571



    46,925

    15,516



    Total revenues

    18,450

    15,400



    108,621

    59,288















    Costs and expenses:













    Cost of product sales

    321

    178



    895

    906



    Research and development (see Note A)  

    15,138

    14,247



    60,101

    52,885



    Selling, general and administrative (see Note A)

    21,818

    18,312



    76,598

    74,588



         Total costs and expenses

    37,277

    32,737



    137,594

    128,379















    Loss from operations 

    (18,827)

    (17,337)



    (28,973)

    (69,091)

    Interest income 

    19

    464



    582

    2,532

    Interest expense

    (429)

    (327)



    (1,353)

    (335)















    Net loss

    $           (19,237)

    $           (17,200)



    $           (29,744)

    $           (66,894)















    Net loss per share, basic and diluted

    $               (0.11)

    $               (0.10)



    $               (0.18)

    $               (0.40)















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

    169,039

    167,619



    168,754

    167,400





























    Note A

























    Stock-based compensation expense included in:













    Selling, general and administrative

    $              1,242

    $                 934



    $              5,223

    $              6,453



    Research and development

    388

    477



    2,072

    2,662





    $              1,630

    $              1,411



    $              7,295

    $              9,115































    SUMMARY BALANCE SHEET DATA









    (in thousands)

























    December 31,











    2020

    2019























    Cash, cash equivalents and short-term investments 

    $            57,327

    $            98,078









    Total assets 

    110,378

    147,569









    Stockholders' equity

    34,026

    53,815



























































































     

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  16. 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: ir@rigel.com

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  17. 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; mark.taylor@lilly.com; (317) 276-5795 (Lilly Media)



    Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Lilly Investors)



    Rigel Investor Contact - (650) 624-1232; ir@rigel.com



    Rigel Media Contact – (508) 314-3157; emily.correia@syneoshealth.com

     

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  18. 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: ir@rigel.com

    Rigel Media Contact:

    Phone: 315-409-9783

    Email: heather.swift@syneoshealth.com

     

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  19. 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: ir@rigel.com

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

     

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  20. 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: dburke@rigel.com

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  21. 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: dburke@rigel.com

     

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  22. 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: mayan@medison.co.il

    Rigel IR Contact: David Burke

    Phone: 650.624.1232

    Email: dburke@rigel.com

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

     

     

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    SOURCE Rigel Pharmaceuticals, Inc.; Medison Pharma

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  23. 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: dburke@rigel.com

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  24. 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: dburke@rigel.com

     

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  25. 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: dburke@rigel.com

     

    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

     

     

     

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-reports-third-quarter-2020-financial-results-and-provides-business-update-301167435.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  26. 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: dburke@rigel.com

    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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  27. 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: dburke@rigel.com

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

     

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  28. 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: dburke@rigel.com

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

     

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  29. 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: dburke@rigel.com

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

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  30. 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: dburke@rigel.com

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

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  31. 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: dburke@rigel.com

    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