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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) reported positive topline results from a Phase 2 clinical trial of fostamatinib, its SYK inhibitor, for hospitalized COVID-19 patients. The trial met its primary safety endpoint, halving the incidence of Serious Adverse Events (SAEs) compared to placebo. Key findings include zero deaths in the fostamatinib group versus three in placebo, and a four-day reduction in ICU stay. Rigel plans to pursue emergency use authorization (EUA) from the FDA based on these results, highlighting fostamatinib's potential to improve outcomes in severe COVID-19 cases.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced the closing of a global exclusive license agreement with Eli Lilly on April 7, 2021. This strategic collaboration aims to co-develop Rigel's RIPK1 inhibitor, R552, for various autoimmune and inflammatory diseases. Effective March 27, 2021, Rigel received a $125 million upfront payment from Lilly. Lilly will oversee clinical development for CNS diseases. Rigel is also advancing its investigational product, fostamatinib, currently in multiple clinical trials for conditions including COVID-19 and autoimmune diseases.
Rigel Pharmaceuticals (Nasdaq: RIGL) has completed patient enrollment in a Phase 2 clinical trial evaluating fostamatinib, an oral spleen tyrosine kinase inhibitor, for hospitalized COVID-19 patients. This NIH-sponsored study, conducted at major clinical centers, involves 58 patients and aims to assess safety and efficacy through various endpoints over 60 days. Results are expected in April 2021. Fostamatinib is already approved for chronic immune thrombocytopenia treatment and may address complications from COVID-19, including thromboinflammation.
Rigel Pharmaceuticals (RIGL) reported its financial results for Q4 and the full year 2020, showing total revenues of $108.6 million, a significant increase from $59.3 million in 2019. TAVALISSE net sales reached $61.7 million, up 41% year-over-year. Despite the revenue growth, Rigel faced a net loss of $29.7 million for the year. Key developments included a $125 million collaboration with Eli Lilly for RIP1 inhibitors and ongoing clinical trials for fostamatinib, including for COVID-19 and warm autoimmune hemolytic anemia. The company ended the year with $57.3 million in cash and equivalents.
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) will disclose its fourth quarter and year-end 2020 financial results on March 2, 2021, after market close. A conference call will follow at 4:30 PM ET, with live access provided via phone or webcast on the company’s website. Rigel focuses on developing small molecule drugs for hematologic disorders, cancer, and rare immune diseases, including its FDA-approved product TAVALISSE. Ongoing clinical trials include studies for conditions like warm autoimmune hemolytic anemia and COVID-19.
Eli Lilly and Rigel Pharmaceuticals have announced a global exclusive license agreement to co-develop Rigel's RIPK1 inhibitor, R552, targeting autoimmune and inflammatory diseases. Lilly will make an upfront payment of $125 million and could pay up to $835 million in milestone payments, plus royalties. R552 has completed Phase 1 trials and will enter Phase 2 trials in 2021. Lilly will lead clinical development and commercialization efforts, while Rigel retains co-commercialization rights in the U.S. This partnership seeks to advance treatments in both immune and CNS disease areas.
Rigel Pharmaceuticals has received $16.5 million from the U.S. Department of Defense to support a Phase 3 clinical trial for fostamatinib in hospitalized COVID-19 patients. This funding is aimed at evaluating the drug's safety and efficacy, following data from a Phase 2 trial expected in April 2021. The trial will enroll over 300 patients and could lead to an Emergency Use Authorization for this treatment. Fostamatinib is already approved for chronic immune thrombocytopenia, indicating a repurposing of an existing drug to expedite treatment options for COVID-19.
Rigel Pharmaceuticals (Nasdaq: RIGL) announced a business update on January 11, 2021, highlighting key metrics from 2020. TAVALISSE sales increased by 41% year-over-year, reaching approximately $17.7 million in Q4 2020. The FDA granted Fast Track designation for wAIHA, and ongoing clinical trials for COVID-19 are progressing, with results expected in April. However, cash reserves decreased to $57.3 million from $98 million the previous year, raising concerns about long-term financial stability.
Rigel Pharmaceuticals (Nasdaq: RIGL) announced that CEO Raul Rodriguez will present a company overview at the 39th Annual J.P. Morgan Virtual Healthcare Conference on January 14, 2021, at 10:00 a.m. Eastern Time. The presentation will be accessible via Rigel's website. Rigel focuses on developing small molecule drugs for hematologic disorders, cancer, and rare immune diseases, with its first FDA-approved product being TAVALISSE. The company is also conducting multiple clinical trials, including studies on fostamatinib for treating COVID-19.
Rigel Pharmaceuticals (RIGL) announced that data on TAVALISSE (fostamatinib) will be showcased at the 62nd American Society of Hematology Annual Meeting from December 5-8, 2020. Key presentations include long-term safety data from over 3,500 patients with immune thrombocytopenia (ITP) and rheumatoid arthritis, showing no new safety signals. Additionally, the company will discuss results from a Phase 3 trial for warm autoimmune hemolytic anemia, where 44% of patients exhibited improved hemoglobin levels. Fostamatinib is the first SYK inhibitor approved for chronic ITP treatment.
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