Rigel Pharmaceuticals Inc Stock Price, News & Analysis

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.

Rigel Pharmaceuticals (Nasdaq: RIGL) announced updated data from its Phase 2 study of olutasidenib for relapsed/refractory mIDH1 acute myeloid leukemia (AML). The interim analysis revealed a 35% complete remission (CR) plus complete remission with partial hematological recovery (CRh) rate and a median duration of 25.9 months. The NDA for olutasidenib is under FDA review, with a target action date of February 15, 2023. Rigel plans to present five posters at the 64th ASH Annual Meeting, highlighting its hematology-oncology portfolio.

Rigel Pharmaceuticals (Nasdaq: RIGL) announced top-line results from the FOCUS Phase 3 trial evaluating fostamatinib in high-risk COVID-19 patients. The trial did not meet the primary endpoint for statistical significance (p=0.0603) in days on oxygen by Day 29, though secondary endpoints favored fostamatinib, such as a 50% reduction in mortality (4 vs. 8 deaths). The safety profile matched prior results with no new issues. Rigel is considering next steps in collaboration with the U.S. Department of Defense.

Rigel Pharmaceuticals will release its third quarter 2022 financial results after market close on November 3, 2022. A conference call will follow at 4:30 PM ET to discuss the results and business updates. Investors can join the call by dialing 877-407-3088 or 201-389-0927, and a live webcast will be available on Rigel's Investor Relations website. The event will be archived for 90 days. Rigel focuses on developing small molecule drugs for hematologic disorders, cancer, and rare immune diseases.