Welcome to our dedicated page for Rigel Pharmaceuticals (New) news (Ticker: RIGL), a resource for investors and traders seeking the latest updates and insights on Rigel Pharmaceuticals (New) stock.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a leading biotechnology company based in South San Francisco, California, dedicated to discovering, developing, and providing novel therapies that significantly improve the lives of patients with immune and hematologic disorders, cancer, and rare diseases. Established in 1996, Rigel has built a solid reputation in the pharmaceutical industry by focusing on the development of small-molecule drugs.
The company's flagship product, TAVALISSE (fostamatinib disodium hexahydrate) tablets, is the only oral spleen tyrosine kinase (SYK) inhibitor approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
REZLIDHIA (olutasidenib), another key product, is an oral small-molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1), indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible IDH1 mutation.
Rigel's pipeline includes a variety of promising candidates such as R289, an IRAK1/4 dual inhibitor for the treatment of lower-risk myelodysplastic syndrome (LR-MDS), R552, R835, THF-beta Inhibitors, and AZD0449 - an inhaled JAK inhibitor. The company is also exploring the potential of olutasidenib in high-grade glioma (HGG) through a collaboration with CONNECT, an international network of pediatric cancer centers.
Recent financial highlights include a reported net product sales of $104.3 million in 2023, showcasing a significant growth of 36% over the previous year. Rigel's partnership with major pharmaceutical companies like AstraZeneca for their rheumatoid arthritis drug and Grifols S.A. for delivery of drug supplies reinforces their strong market position.
In 2024, Rigel announced the acquisition of U.S. rights to GAVRETO (pralsetinib), a kinase inhibitor approved for treating metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic RET fusion-positive thyroid cancer. This acquisition aligns with Rigel's strategy to expand its hematology and oncology portfolio, leveraging its existing commercial infrastructure.
Rigel continues to focus on commercial execution, strategic collaborations, and advancing its robust pipeline to reach financial breakeven and deliver transformative treatments to underserved patient populations.
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.
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