Scholar Rock advances apitegromab FDA review
- Scholar Rock removed Catalent Indiana as a commercial fill-finish facility from its apitegromab BLA for spinal muscular atrophy.
- The FDA review is continuing with an alternate fill-finish facility ahead of the September 30, 2026 PDUFA date.
- Scholar Rock plans to resubmit its European application and submit a Japanese application by the end of 2026.
Scholar Rock (NASDAQ:SRRK) removed Catalent Indiana as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA), with FDA review continuing using an alternate facility.
The company said the FDA review is progressing with the alternate fill-finish facility and that an approval decision may come by the September 30, 2026 Prescription Drug User Fee Act (PDUFA) date.
Scholar Rock withdrew its apitegromab Marketing Authorisation Application (MAA) in Europe after Catalent Indiana received an Official Action Indicated classification from the FDA following an April 2026 inspection, and plans to resubmit with the alternate fill-finish facility.
Following the announcement, Scholar Rock's share price was unchanged at $39.20 in premarket trading.
Scholar Rock said it has commercial supply of apitegromab vials from the alternate fill-finish facility available to support a potential U.S. launch following regulatory approval.
The company also said Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) agreed that no additional clinical studies in Japanese patients are required for an apitegromab New Drug Application.
Scholar Rock plans to submit a Japanese New Drug Application for apitegromab for children and adults with SMA by the end of 2026.
