RIGL Rigel Pharmaceuticals Inc.

1.93
+0.02  (+1%)
Previous Close 1.91
Open 1.97
52 Week Low 1.23
52 Week High 3.1
Market Cap $325,339,183
Shares 168,569,525
Float 145,466,910
Enterprise Value $260,955,792
Volume 694,695
Av. Daily Volume 1,888,064
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Drug Pipeline

Drug Stage Notes
Fostamatinib
Autoimmune hemolytic anemia (AIHA)
Phase 3
Phase 3
Phase 3 (most) sites have temporarily postponed new patient enrollment due to COVID-19 - May 5, 2020.
R835
Autoimmune and inflammatory diseases
Phase 1
Phase 1
Phase 1 trial has been completed - noted October 23, 2019.
Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Approved
Approved
Approved April 17, 2018.
Fostamatinib
IgA nephropathy
Phase 2
Phase 2
Phase 2 data released April 3, 2018. Primary endpoint not met.
R348
Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD)
Phase 2
Phase 2
Phase 2 trial did not meet endpoints

Latest News

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

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

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

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

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

    About Rigel (www.rigel.com) 

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

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

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

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

    Contact: David Burke

    Phone: 650.624.1232

    Email:

     

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

     

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

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

    Fostamatinib disodium…

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

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

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

    Poster Presentation

    Abstract #EP1625

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

    Presenter: Dr. Nichola Cooper

    Session Topic: 32. Platelets Disorders  

    About ITP

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

    About AIHA 

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

    About TAVALISSE

    Indication

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

    Important Safety Information

    Warnings and Precautions

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

    Drug Interactions

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

    Adverse Reactions

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

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

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

    TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

    About Rigel (www.rigel.com)

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

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

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

    Forward Looking Statements

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

    IR Contact: David Burke 

    Phone: 650.624.1232

    Email: 

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

     

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

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

     

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

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

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

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

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

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

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

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

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

    Contact: David Burke
    Phone: 650.624.1232
    Email:

     

     

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Important Safety Information
    Warnings and Precautions

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

    Drug Interactions

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

    Adverse Reactions

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

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

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

    TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

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

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

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

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

    IR Contact: David Burke 
    Phone: 650.624.1232
    Email: 

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

     

    RIGEL PHARMACEUTICALS, INC.

    STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)











    Three Months Ended March 31,



    2020

    2019



    (unaudited)





    Revenues:




    Product sales, net

    $         12,680

    $              8,054


    Contract revenues from collaborations 

    43,081

    4,570


    Total revenues

    55,761

    12,624





    Costs and expenses:




    Cost of product sales

    155

    107


    Research and development (see Note A)  

    16,149

    10,949


    Selling, general and administrative (see Note A)

    18,430

    19,946


         Total costs and expenses

    34,734

    31,002

    Loss from operations 

    21,027

    (18,378)

    Interest income 

    358

    780

    Interest expense

    (142)

    Net income (loss)

    $         21,243

    $          (17,598)





    Net income (loss) per share




    Basic

    $             0.13

    $              (0.11)


    Diluted

    $             0.13

    $              (0.11)





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



    Basic

    168,469

    167,173


    Diluted

    168,568

    167,173









    Note A







    Stock-based compensation expense included in:




    Selling, general and administrative

    $           1,330

    $              2,166


    Research and development

    694

    787



    $           2,024

    $              2,953










    SUMMARY BALANCE SHEET DATA


    (in thousands)







    March 31,

    December 31,



    2020

    2019 (1)



     (unaudited) 



    Cash, cash equivalents and short-term investments 

    $         95,926

    $            98,078


    Total assets 

    143,363

    147,569


    Stockholders' equity

    78,499

    53,815





    (1)

    Derived from audited financial statements







     

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    SOURCE Rigel Pharmaceuticals, Inc.

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