Regeneron Pharmaceuticals Announces Data From Its Phase 3 OPTIMA Study Of Pasatru To Treat Fibrodysplasia Ossificans Progressiva Shows Efficacy In Stopping New Bone Growth; Trial Meets Primary Endpoint By Reducing 90% New Heterotopic Ossification Lesions

10/12/2026
Impact: 85
Healthcare

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive results from its Phase 3 OPTIMA trial of Pasatru (garetosmab-grts) for treating fibrodysplasia ossificans progressiva (FOP), showing a 90% reduction in new heterotopic ossification lesions over 84 weeks. The trial met its primary endpoint by demonstrating sustained efficacy in halting new bone growth and reducing disease flare-ups. Pasatru was previously approved by the FDA based on a 56-week placebo-controlled trial.

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