Welcome to our dedicated page for Rigel Pharmaceuticals news (Ticker: RIGL), a resource for investors and traders seeking the latest updates and insights on Rigel Pharmaceuticals stock.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a commercial stage biotechnology company based in South San Francisco, California, focused on therapies for hematologic disorders and cancer. This news page aggregates company announcements, financial updates and clinical data disclosures so readers can follow Rigel’s progress across its marketed products and development pipeline.
Rigel’s news flow frequently covers net product sales and total revenue from its hematology and oncology portfolio, including TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib). Press releases detail quarterly and preliminary annual revenue, contract revenues from collaborations and government contracts, and commentary from management on commercial execution and financial performance.
Clinical and regulatory milestones are another major focus of Rigel’s news. Updates describe Phase 1b data for the investigational IRAK1/4 dual inhibitor prodrug R289 in relapsed or refractory lower-risk myelodysplastic syndrome, including safety, tolerability, pharmacokinetics and measures such as red blood cell transfusion independence. The company also reports on long-term and real-world data for REZLIDHIA in mIDH1 acute myeloid leukemia, and on presentations of pralsetinib data in RET fusion-positive solid tumors at oncology conferences.
Rigel’s releases highlight participation in scientific and investor meetings, such as the American Society of Hematology Annual Meeting and Exposition, the American Society of Clinical Oncology – Gastrointestinal Cancers Symposium, and major healthcare investment conferences. Corporate news can also include collaboration updates, such as developments in the ocadusertib program with Eli Lilly and Company, and stock-based inducement grants under Nasdaq Listing Rule 5635(c)(4).
Investors, clinicians and researchers can use this RIGL news feed to monitor earnings announcements, pipeline readouts, regulatory designations and conference presentations that shape the company’s trajectory in hematology and oncology.
Rigel Pharmaceuticals (NASDAQ: RIGL) announced positive results from its Phase 2 study of REZLIDHIA (olutasidenib) for treating mutant isocitrate dehydrogenase 1 (mIDH1) relapsed or refractory acute myeloid leukemia (R/R AML). The study, published in Blood Advances, included 153 adult patients, revealing a 35% complete remission plus complete remission with partial hematologic recovery (CR+CRh) rate. Notably, patients achieving CR+CRh had a median overall survival (OS) not yet reached, with 78% survival at 18 months. REZLIDHIA shows promise as a differentiated therapy, particularly following its recent FDA approval.
Rigel Pharmaceuticals (Nasdaq: RIGL) announced that REZLIDHIA (olutasidenib) has been included in the NCCN Clinical Practice Guidelines for acute myeloid leukemia (AML) as a recommended therapy for adult patients with relapsed/refractory AML carrying an IDH1 mutation. This recognition comes shortly after the FDA approved REZLIDHIA for adults with R/R AML in December 2022. The NCCN Guidelines are widely regarded as the standard for cancer care. CEO Raul Rodriguez expressed satisfaction with this prompt inclusion, underscoring the strength of REZLIDHIA's safety and efficacy data.
Rigel Pharmaceuticals (RIGL) announced FDA approval and commercial launch of REZLIDHIA for treating adult patients with relapsed or refractory AML with IDH1 mutations. Preliminary Q4 2022 revenue is expected to be approximately $51.3 million, driven by TAVALISSE sales of about $21.9 million. The company also recognized a $20 million milestone from Kissei for TAVALISSE’s approval in Japan. Rigel's cash position is $58.2 million, down from $125 million in 2021. Upcoming catalysts include ongoing clinical trials for R289 and R552, aimed at expanding their hematology-oncology portfolio.
Rigel Pharmaceuticals (Nasdaq: RIGL) has launched REZLIDHIA™ (olutasidenib) capsules in the U.S. for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) with a particular IDH1 mutation. Approved by the FDA on December 1, 2022, REZLIDHIA offers a new oral treatment option designed to improve patient outcomes. The wholesale acquisition cost is $32,200 monthly. The company also provides support through RIGEL ONECARE® to assist with insurance and financial needs.
Rigel Pharmaceuticals announced the commencement of a Phase 1b study for R289, an investigational IRAK1/4 dual inhibitor aimed at treating lower-risk myelodysplastic syndromes (MDS). The first patient has been dosed as part of this open-label study, which will enroll around 22 refractory or resistant MDS patients. The primary objective focuses on safety, with additional goals to assess preliminary efficacy and pharmacokinetic profiles. This study is vital for determining the recommended Phase 2 dose for future development of R289, highlighting Rigel's commitment to innovative treatments in hematology-oncology.
Optime Care has partnered with Rigel Pharmaceuticals to provide comprehensive patient support services for Rezlidhia™ (olutasidenib), an FDA-approved treatment for acute myeloid leukemia in patients with IDH1 mutations. This collaboration will enable enhanced patient management through services including medication fulfillment and prior authorization support. Rigel Pharmaceuticals emphasizes the importance of Optime Care's expertise in rare diseases to improve therapeutic outcomes for Rezlidhia patients. The partnership reflects a commitment to advancing treatment journeys for those affected by acute myeloid leukemia.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced the granting of 375,000 stock options to new employee Ray Furey, consisting of 187,500 options vesting over four years and another 187,500 options contingent on future performance conditions. This incentive aligns with NASDAQ's Listing Rule 5635(c)(4), which allows inducement awards for new hires. Rigel focuses on developing novel small molecule drugs for hematologic disorders, cancer, and rare immune diseases, enhancing its workforce to support these initiatives.
Rigel Pharmaceuticals announced the FDA approval of REZLIDHIA (olutasidenib) for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying an IDH1 mutation. This oral mIDH1 inhibitor yielded a 35% complete remission (CR) rate in a Phase 2 trial, with a median duration of response of 25.9 months. The approval is a significant development for R/R AML patients, improving treatment options. The company plans to commercialize REZLIDHIA in the U.S., enhancing their hematology-oncology portfolio.
Rigel Pharmaceuticals announced positive early clinical data for olutasidenib, an investigational treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), published in The Lancet Haematology. The Phase 1/2 study demonstrated a 77% overall response rate for treatment-naïve AML patients receiving combination therapy and noted significant improvements in clinical efficacy endpoints. The PDUFA target action date for olutasidenib is set for February 15, 2023, with expectations for regulatory approval, enhancing its potential market impact.
Rigel Pharmaceuticals (RIGL) reported its third-quarter 2022 financial results, highlighting net product sales of TAVALISSE® at $19.2 million, a 20% increase year-over-year. Total revenues reached $22.4 million, with a net loss of $19 million, or $0.11 per share, showing improvement from a $21 million loss in Q3 2021. The FDA is reviewing the NDA for olutasidenib, with a target action date set for February 15, 2023. The company also presented promising data on olutasidenib's efficacy in AML at ASH and reported a 16% reduction in workforce, affecting 30 positions.