News Related to Hole Lesions

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Regeneron's Garetosmab Receives FDA Priority Review for Rare Bone Disorder FOP

Mar 02, 2026

The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.

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.