Business Wire·Aug 21, 2026, 9:06 AM ET

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

Scholar Rock successfully removed Catalent Indiana LLC as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) under FDA guidance due to an Official Action Indicated (OAI) inspection classification.
FDA review of the BLA is progressing well with an alternate U.S.-based fill-finish facility, & the company expects an approval decision by the September 30, 2026 PDUFA date.
A robust supply of apitegromab commercial vials from the alternate facility is available to support an immediate U.S. launch upon FDA approval.
The company withdrew its European apitegromab Marketing Authorisation Application (MAA) & plans to resubmit with the alternate fill-finish facility to expedite the Committee for Medicinal Products for Human Use (CHMP) opinion.
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) agreed that no additional clinical studies are required, allowing Scholar Rock to submit a Japanese New Drug Application (JNDA) by year-end 2026.
Apitegromab is an investigational myostatin inhibitor that previously received Fast Track, Orphan Drug, & Rare Pediatric Disease designations from the FDA.