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 (NASDAQ: RIGL) announced the enrollment of the first patient in a NIH/NHLBI-sponsored Phase 1 study evaluating fostamatinib in sickle cell disease (SCD) patients. The study will assess the safety and tolerability of escalating doses of fostamatinib, Rigel's oral SYK inhibitor, which is already approved as TAVALISSE® for chronic immune thrombocytopenia.
The open-label Phase 1 dose-escalation study aims to enroll approximately 20 patients with SCD. Patients will receive 100 mg twice daily for 14 days, potentially escalating to 150 mg twice daily for an additional 28 days if tolerated. The study will evaluate safety, tolerability, and investigate fostamatinib's mechanism of action in SCD, including its effects on red blood cell membrane integrity, sickling kinetics, and platelet activation.
The trial is being conducted at the NIH Clinical Center in Bethesda, Maryland, with study material provided by Rigel. SCD affects over 100,000 people in the United States and an estimated 7-8 million people worldwide.
Rigel Pharmaceuticals (RIGL) reported preliminary Q4 2024 total revenue of $57.6 million, including net product sales of TAVALISSE ($31.0M), REZLIDHIA ($7.4M), and GAVRETO ($8.1M). The company expects full-year 2024 total revenue of $179.3 million, with net product sales of $144.9 million.
Key developments include TAVALISSE surpassing $100 million in 2024 net product sales, R289 receiving FDA Orphan Drug designation for MDS treatment, and an exclusive license agreement with Dr. Reddy's for REZLIDHIA commercialization worth up to $40 million in total payments.
Looking ahead to 2025, Rigel anticipates total revenue of $200-210 million, including net product sales of $185-192 million and contract revenues of $15-18 million. The company expects to achieve positive net income while funding clinical development programs.
Rigel Pharmaceuticals (NASDAQ: RIGL) announced that its drug candidate R289 has received Orphan Drug designation from the FDA for treating myelodysplastic syndromes (MDS). R289, a dual inhibitor of IRAK1 and IRAK4, is currently in a Phase 1b study evaluating its safety, tolerability, and preliminary activity in patients with lower-risk MDS who haven't responded to previous treatments.
The Orphan Drug designation provides several benefits, including tax credits, FDA fee exemptions, and potential seven-year market exclusivity upon approval. R289 had previously received Fast Track designation for treating patients with previously-treated transfusion-dependent lower-risk MDS.
R289 is a prodrug of R835 that works by blocking inflammatory cytokine production in response to toll-like receptor and interleukin-1 receptor family signaling, which are thought to cause pro-inflammatory conditions in the bone marrow of lower-risk MDS patients.
Rigel Pharmaceuticals (Nasdaq: RIGL), a commercial stage biotechnology company specializing in hematologic disorders and cancer treatments, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's president and CEO, Raul Rodriguez, will deliver a company overview on Thursday, January 16, 2025, at 8:15 a.m. PT (11:15 a.m. ET) in San Francisco.
The presentation will be accessible via live webcast through the Investor Relations section of Rigel's website. Founded in 1996 and headquartered in South San Francisco, California, Rigel focuses on discovering, developing, and providing innovative therapies for patients with hematologic disorders and cancer.
Rigel Pharmaceuticals (Nasdaq: RIGL) has announced the granting of inducement awards under its Inducement Plan, as approved by the company's Compensation Committee. The grants, made in accordance with NASDAQ Listing Rule 5635(c)(4), consist of 46,131 stock options awarded to eight non-executive employees. These options will vest over a four-year period with a one-year cliff.
The awards were granted as material inducements for these employees entering into employment with Rigel. The company, founded in 1996 and based in South San Francisco, California, focuses on developing and providing novel therapies for patients with hematologic disorders and cancer.
Rigel Pharmaceuticals (NASDAQ: RIGL) announced initial data from its ongoing Phase 1b study of R289 in lower-risk myelodysplastic syndrome (LR-MDS) patients. The study showed promising results with 40% of evaluable transfusion-dependent patients receiving R289 doses ≥500 mg QD achieving red blood cell transfusion independence or hematologic improvement.
The trial enrolled 22 patients with a median age of 76 years. R289 was generally well-tolerated, with most common side effects being Grade 1/2 diarrhea and fatigue. Three patients achieved RBC transfusion independence ≥8 weeks, with two maintaining it for >24 weeks. The median duration of RBC transfusion independence was 29 weeks.
The FDA recently granted Fast Track designation for R289 in previously-treated transfusion-dependent LR-MDS patients.
Rigel Pharmaceuticals (Nasdaq: RIGL) announced that the FDA has granted Fast Track designation to R289 for treating patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS). R289, a dual inhibitor of IRAK1 and IRAK4, is currently being evaluated in a Phase 1b study. The Fast Track designation may provide benefits including more frequent FDA interactions and eligibility for Accelerated Approval and Priority Review. The drug works by blocking inflammatory cytokine production in response to toll-like receptor and interleukin-1 receptor family signaling, targeting the pro-inflammatory environment in bone marrow responsible for persistent cytopenias in lower-risk MDS patients.
Rigel Pharmaceuticals (Nasdaq: RIGL) has announced that CFO Dean Schorno will present a company overview at the Jefferies London Healthcare Conference on Tuesday, November 19, at 9:30 am GMT (4:30 am EST). The presentation will be accessible via live webcast through the Investor Relations section of Rigel's website.
Founded in 1996 and based in South San Francisco, Rigel is a commercial stage biotechnology company focusing on developing therapies for hematologic disorders and cancer. The company aims to discover, develop, and provide novel treatments that improve patients' lives.
Rigel Pharmaceuticals reported strong Q3 2024 financial results with total revenue of $55.3 million, including TAVALISSE net sales of $26.3 million (8% growth), REZLIDHIA net sales of $5.5 million (107% growth), and GAVRETO net sales of $7.1 million. The company secured a $10 million upfront payment from Kissei for REZLIDHIA development rights in Japan, Korea, and Taiwan. Rigel achieved Q3 net income of $12.4 million ($0.71 per share) compared to a net loss of $5.7 million in Q3 2023. Cash position strengthened to $61.1 million as of September 30, 2024.
Rigel Pharmaceuticals (RIGL) announced six poster presentations at the upcoming ASH Annual Meeting, featuring data from their hematology-oncology portfolio. Key highlights include initial results from a Phase 1b study of R289 in lower-risk MDS patients, showing 36% achieved RBC-transfusion independence at doses ≥500 mg QD. The presentations also include data on REZLIDHIA (olutasidenib) in mIDH1 AML patients, demonstrating durable responses when combined with azacitidine, and TAVALISSE (fostamatinib) real-world outcomes in ITP treatment.
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