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 and Forma Therapeutics have announced a worldwide licensing agreement for olutasidenib, a potential treatment for relapsed/refractory acute myeloid leukemia (R/R AML). The FDA has accepted Forma's New Drug Application with a PDUFA date set for February 15, 2023. Rigel will pay Forma an upfront fee of $2 million, with additional milestones potentially totaling $215.5 million. Olutasidenib showed a 33% complete remission rate in a Phase 2 trial, with an 18-month survival rate of 87% among responders. This agreement expands Rigel's oncology portfolio, enhancing its commercialization capabilities.
Rigel Pharmaceuticals (Nasdaq: RIGL) will announce its Q2 2022 financial results on August 2, 2022, after market close. Senior management will host a conference call at 4:30 PM ET to discuss results and provide a business update. Rigel specializes in developing small molecule drugs for hematologic disorders, cancer, and rare immune diseases. Its product TAVALISSE® is the only oral SYK inhibitor approved for chronic immune thrombocytopenia. Ongoing clinical trials include treatments for autoimmune hemolytic anemia and COVID-19.
Rigel Pharmaceuticals (RIGL) announced the FORWARD Phase 3 clinical trial results for fostamatinib in treating warm autoimmune hemolytic anemia (wAIHA). The trial failed to meet the primary efficacy endpoint of durable hemoglobin response across the overall study population, with a 35.6% response rate in the fostamatinib group versus 26.7% in placebo (P=0.398). However, a post-hoc analysis revealed a favorable response in U.S., Canada, and Western Europe (P=0.03). The safety profile was consistent, with no new safety concerns reported. Rigel plans further data analysis and discussions with the FDA.
Rigel Pharmaceuticals reported first-quarter 2022 financial results, highlighting TAVALISSE® net product sales of $16.2 million and total revenues of $16.7 million. This marks a 31% increase in TAVALISSE sales compared to Q1 2021. The company is awaiting pivotal Phase 3 clinical trial results for fostamatinib in warm autoimmune hemolytic anemia (wAIHA), with topline data expected in mid-2022. However, Rigel reported a net loss of $27.4 million, or $0.16 per share, and total costs increased to $43.0 million.
Rigel Pharmaceuticals (RIGL) will announce its Q1 2022 financial results on May 3, 2022, followed by an investor call at 4:30 PM ET. Dr. Caroline Piatek, a Key Opinion Leader and FORWARD trial investigator, will present insights on warm autoimmune hemolytic anemia (wAIHA) treatment and the potential role of fostamatinib. The ongoing Phase 3 trial evaluates fostamatinib against a placebo in 90 patients who have not responded to prior treatments. Topline data is expected mid-2022. Fostamatinib holds Orphan Drug and Fast Track designations from the FDA.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) granted stock options totaling 626,000 shares to 15 new employees. The options, approved by Rigel's Compensation Committee, were issued as part of the Inducement Plan and have an exercise price of $3.10 per share. Vesting will occur immediately upon achieving performance conditions or over four years, with one-fourth vesting annually. This announcement complies with NASDAQ Listing Rule 5635(c)(4), aiming to incentivize new hires.
Rigel Pharmaceuticals announced the publication of Phase 2 clinical study data on fostamatinib for treating warm antibody autoimmune hemolytic anemia (wAIHA) in the American Journal of Hematology. The study showed that 50% of treated patients achieved significant hemoglobin increases, indicating potential as a first approved therapy for wAIHA. Fostamatinib is also recognized with Orphan Drug and Fast Track designations by the FDA. The company aims for regulatory approval in 2023, as no targeted therapies currently exist for wAIHA patients.
Rigel Pharmaceuticals (RIGL) reported its fourth-quarter and full-year 2021 financial results, highlighting a net loss of $22.6 million for Q4 and $17.9 million for the year. Q4 revenues were $20.4 million, a slight decline in TAVALISSE sales. The company completed enrollment for two pivotal Phase 3 trials in autoimmune conditions and COVID-19, with results expected mid-2022. Rigel aims to expand TAVALISSE's market to include warm autoimmune hemolytic anemia (wAIHA) and COVID-19, potentially increasing its product offerings.
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) will report its fourth quarter and year-end 2021 financial results on March 1, 2022, after market close. A live conference call and webcast will follow at 4:30 PM ET for management to discuss the results and provide business updates. Rigel, known for its TAVALISSE product, focuses on developing drugs for hematologic disorders and rare diseases. The company is also conducting various clinical trials for treatments in autoimmune and COVID-19-related conditions.
Rigel Pharmaceuticals will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 10:30 a.m. ET. CEO Raul Rodriguez will provide a comprehensive overview of the company.
Interested parties can access the live webcast on Rigel's website. Rigel focuses on novel small molecule drugs for various diseases, with its FDA-approved product TAVALISSE for chronic immune thrombocytopenia.
The company is also progressing in clinical trials for multiple conditions, including COVID-19 and autoimmune diseases.
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