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Rigel Pharmaceuticals, Inc. RIGL recently announced that the FDA has declined to issue an emergency use authorization (EUA) to fostamatinib for COVID-19.
The agency has informed the company that clinical data submitted in late May from a phase II study (n=59) on fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an EUA at this time.
Rigel Pharmaceuticals is currently conducting a larger phase III study evaluating fostamatinib in hospitalized patients with COVID-19. The primary endpoint of this study is the proportion of patients who progress to severe/critical disease within 29 days. The study has enrolled approximately 176 patients as of Aug 12, 2021, and the process is expected to be complete by this year-end. The company expects to provide further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients.
Rigel plans to resubmit its EUA application with this additional data if the study is successful.
We note that the development program for fostamatinib in COVID 19 comprises three ongoing studies and a recently completed phase II study. These studies are evaluating a wide range of hospitalized patients, including those not on oxygen therapy and are experiencing mild to severe COVID-19-related complications.
Fostamatinib is also currently being evaluated in a phase III study for the treatment of warm autoimmune hemolytic anemia (wAIHA). The company’s first FDA approved product is Tavalisse (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia who had an insufficient response to a previous treatment. Its other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIP1) inhibitor program in clinical development with partner Eli Lilly and Company LLY.
Shares of Rigel Pharmaceuticals have gained 5.7% so far this year against the industry’s decline of 12.8%.
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Despite the increasing rates of vaccination, the pandemic continues to wreak havoc, giving rise to the need for treatments of those infected particularly against the variants of concern.
The FDA has granted an EUA to Regeneron’s REGN antibody cocktail casirivimab and imdevimab (REGEN-COV) to treat mild-to-moderate COVID-19 in adults and pediatric patients.
The FDA also granted an EUA to GlaxoSmithKline plc GSK and Vir Biotechnology, Inc.’s sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg).
Rigel Pharmaceuticals currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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