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FDA Approves Regeneron Pasatru for FOP — Aug 19, 2026Regeneron's garetosmab, marketed as Pasatru, received FDA approval to treat adults with fibrodysplasia ossificans progressiva, becoming the second FDA-cleared therapy for FOP and the first to reduce clinician-assessed flare-ups. Driven by OPTIMA/phase 3 data showing about 90% reduction in new bone lesions over 56 weeks and substantial decreases in flare-ups, Pasatru competes with Ipsen's Sohonos and awaits EMA/Japan submissions, with price not disclosed.

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