Garetosmab biologics license application accepted for FDA priority review for the treatment of fibrodysplasia ossificans progressiva

Regeneron Pharmaceuticals

19 February 2026 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application for garetosmab for the treatment of adults with fibrodysplasia ossificans progressiva. 

The target action date for the FDA decision is August 2026.

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder