RIGL Rigel Pharmaceuticals Inc.

4
-0.09  -2%
Previous Close 4.09
Open 4.09
52 Week Low 2.14
52 Week High 5.5
Market Cap $680,657,332
Shares 170,164,333
Float 130,882,625
Enterprise Value $693,684,121
Volume 1,325,654
Av. Daily Volume 1,617,975
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Drug Pipeline

Drug Stage Notes
TAVALISSE (Fostamatinib)
Warm Autoimmune hemolytic anemia (WAIHA)
Phase 3
Phase 3
Phase 3 enrollment sites are back open following pause due to COVID-19.
Fostamatinib (NIH ACTIV-4)
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 trial planned.
TAVALISSE (Fostamatinib)
IgA nephropathy
Phase 2
Phase 2
Phase 2 data released April 3, 2018. Primary endpoint not met.
TAVALISSE - Fostamatinib
COVID-19
Phase 3
Phase 3
Phase 2 trial met primary endpoint of safety - April 13, 2021. Phase 3 trial is enrolling.
TAVALISSE (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Approved
Approved
Approved April 17, 2018.
R835
Autoimmune and inflammatory diseases
Phase 1
Phase 1
Phase 1 trial has been completed - noted October 23, 2019.
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., 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:

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

     

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    SOURCE Rigel Pharmaceuticals, Inc.

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  2. 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: 

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

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/new-tavalisse-data-analyses-to-be-presented-at-international-society-on-thrombosis-and-haemostasis-isth-2021-congress-301333202.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  3. 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: 

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

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fostamatinib-selected-for-nih-activ-4-covid-19-clinical-trial-301321604.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  4. 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:  

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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-to-present-at-the-jefferies-virtual-healthcare-conference-301299452.html

    SOURCE Rigel Pharmaceuticals, Inc.

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  5. 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:

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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rigel-appoints-alison-l-hannah-md-to-board-of-directors-301291455.html

    SOURCE Rigel Pharmaceuticals, Inc.

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