Regeneron announces FDA accepted Priority Review for BLA for garetosmab

Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the Biologics License Application, BLA, for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva, FOP. Garetosmab is a monoclonal antibody that blocks Activin A, a protein that Regeneron scientists discovered to be critical in the development of heterotopic ossification lesions in people with FOP. The target action date for the FDA decision is August 2026.