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 reports news on a commercial-stage biotechnology business focused on hematologic disorders and cancer. Company updates commonly cover sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), along with contract revenue from collaborations and quarterly operating results.
Recurring developments also include clinical and regulatory updates for Rigel's pipeline, including R289 in lower-risk MDS, published clinical data involving GAVRETO, licensing and collaboration activity, board appointments, equity inducement grants and other governance matters tied to its Nasdaq-listed common stock.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced it will release its fourth quarter and full year 2022 financial results on March 7, 2023, after market close. Following the report, Rigel's senior management will host a live conference call and webcast at 4:30 p.m. ET to discuss the results and provide a business update. Investors can access the call by dialing a provided number or through the company's website. Rigel focuses on developing novel small molecule drugs for hematologic disorders and cancer.
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.