Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive 84-week results from the Phase 3 OPTIMA trial evaluating Pasatru™ (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva (FOP). These longer-term findings for Pasatru demonstrated sustained efficacy in halting new, rogue bone growth and in significantly reducing disease flare-ups, and were presented during a late-breaking oral session at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting. Pasatru was recently approved by the U.S. Food and Drug Administration (FDA) based on a 56-week, placebo-controlled trial to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with FOP. Pasatru is a VelocImmune®-derived, fully human monoclonal antibody that binds to and inhibits signaling by the Activin A protein, which Regeneron scientists discovered to be a critical protein involved in the development of HO lesions in people with FOP.

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