Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: GlobeNewswire
FOP is an ultra-rare genetic disorder characterized by abnormal bone formation that infiltrates muscles, tendons, ligaments and other connective tissues, resulting in significant disability If approved, garetosmab would be the first and only available treatment shown to reduce the number and volume of new heterotopic bone lesions in adults with FOP TARRYTOWN, N.Y., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva (FOP). Garetosmab is a monoclonal antibody that blocks Activin A, a protein that Regeneron scientists discovered to be critical in the development of heterotopic ossification (HO) lesions in people with FOP. The target action date for the FDA decision is August 2026. FOP is a relentless, ultra-rare genetic disorder in
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- 1/30/26 - Beat
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- 2/23/26 - Form 4
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- REGN's page on the SEC website