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FDA Grants Priority Review to Garetosmab for Rare Bone Disorder Fibrodysplasia Ossificans Progressiva

Feb 20, 2026

The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.

FDA Accepts Garetosmab BLA for Priority Review in Fibrodysplasia Ossificans Progressiva

Feb 19, 2026

The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.