FDA Approves Regeneron's (REGN) Pasatru for Ultra-Rare FOP in August 2026; Shares Up 5.4%

English summary

In August 2026, Regeneron Pharmaceuticals announced that the US FDA approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification lesions and flare-ups in adults with fibrodysplasia ossificans progressiva, based on positive Phase 3 OPTIMA trial results. This approval adds a rare-disease monoclonal antibody to Regeneron's portfolio, reinforcing its focus on specialized, high-complexity immunology therapies.