Regeneron Garetosmab Biologics License Application Accepted for FDA Priority Review

Regeneron (NASDAQ: REGN) announced the FDA has accepted the Biologics License Application for garetosmab for adults with fibrodysplasia ossificans progressiva (FOP) and granted Priority Review with a target action date in August 2026.

The BLA is supported by positive Phase 3 OPTIMA results showing large reductions in new heterotopic bone lesions and volume versus placebo, and a safety profile with common adverse reactions including epistaxis and increased hair growth.

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