SOUTH SAN FRANCISCO, Calif., Oct. 10, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has received guidance from the U.S. Food and Drug Administration (FDA)'s review of the Company's re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA). Based on this guidance, Rigel does not expect to file a supplemental New Drug Application (sNDA) for this indication at this time. Rigel will continue to explore its options for the wAIHA program in relation to its complete portfolio of development opportunities.
SOUTH SAN FRANCISCO, Calif., June 8, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced top-line efficacy and safety data from the FORWARD Phase 3 clinical trial, a global, multi-center, randomized, double-blind, placebo-controlled trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. In a post-hoc regional analysis of U.S., Canadian, Australian, and Western European trial sites, patients treated with fostamatinib had a favorable durable hemoglobin response compared to placebo, whereas in the Eastern European trial sites patients did not. Rigel plans to continue analyzing the data to understand the geographical differences in patient disease characteristics and outcomes and discuss these findings with the U.S. Food and Drug Administration (FDA).
SOUTH SAN FRANCISCO, Calif., Nov. 15, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced plans to exit early-stage research and focus resources on its mid to late-stage development programs and its commercial efforts. The strategy will strengthen Rigel's ability to build value for shareholders by executing on the company's near-term value drivers: growing ITP sales, expanding the addressable market for TAVALISSE® (fostamatinib) with warm autoimmune hemolytic anemia (wAIHA) and COVID-19, advancing its wholly-owned IRAK1/4 program in hematology and immunology, and exploring other opportunities that will complement Rigel's hematology/oncology-focused commercial offerings.
Rigel Pharmaceuticals have announced the publication of results from a Phase II clinical trial evaluating the safety of fostamatinib for the treatment of hospitalised patients with COVID-19.
SOUTH SAN FRANCISCO, Calif., Sept. 1, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced the publication of results from a Phase 2 clinical trial evaluating the safety of fostamatinib for the treatment of hospitalized patients with COVID-19, in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America. The study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System.
Four months after Rigel announced possible Phase II results for its Covid-19 treatment, the FDA has deemed the sample size too small and insufficient for an emergency use authorization, the company announced Friday.
SOUTH SAN FRANCISCO, Calif., June 29, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that fostamatinib, the Company's novel oral spleen tyrosine kinase (SYK) inhibitor, has been selected for a National Institutes of Health (NIH) ACTIV-4 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in hospitalized patients with COVID-19.
SOUTH SAN FRANCISCO, Calif., March 11, 2021 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the completion of patient enrollment in a multi-center Phase 2 clinical trial to evaluate the safety of fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System. Fostamatinib is marketed in the U.S. as TAVALISSE® (fostamatinib disodium hexahydrate) tablets, and is approved in the U.S., Europe, and Canada as a treatment for adult chronic immune thrombocytopenia (ITP).
Rigel Pharmaceuticals (NASDAQ:RIGL) has enrolled the first patient in a Phase 2 trial evaluating fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of hospitalized COVID-19 patients. The study is sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH), in collaboration with Inova Health System.