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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 (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.
Rigel Pharmaceuticals announced a workforce reduction of 16%, equating to 30 positions, primarily affecting development and administration. This decision follows the FDA's guidance regarding Rigel's wAIHA program, resulting in a delay in filing a supplemental New Drug Application. The workforce reduction is expected to incur a one-time severance charge of approximately $1.5 million in Q4 2022 but will reduce operating expenses by $7-$8 million annually starting in 2023. Despite these challenges, Rigel continues to pursue opportunities in its ongoing programs.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that CFO Dean Schorno will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 2:00 p.m. ET in New York City. Investors can access a live and archived webcast on Rigel's website. Rigel focuses on developing innovative small molecule drugs for hematologic disorders, cancer, and rare immune diseases, with FDA-approved TAVALISSE for immune thrombocytopenia and olutasidenib for relapsed acute myeloid leukemia among its key products. For more details, visit www.rigel.com.
Rigel Pharmaceuticals reported Q2 2022 financial results, highlighting net product sales of $18.6 million for TAVALISSE, a 9% increase year-over-year. Total revenues reached $29.8 million. The company entered a license agreement with Forma Therapeutics for olutasidenib, targeting a 2023 launch, while completing enrollment in a pivotal Phase 3 trial for COVID-19. Rigel reported a net loss of $13.5 million, with total costs rising to $42.8 million. The cash position was $89.2 million as of June 30, 2022, down from $125 million at 2021 year-end.
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.
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