Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date

Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date

Today, August 7, 2026, Scholar Rock received customer notification from Catalent Indiana LLC (part of Novo Nordisk) that FDA classified the April 2026 site inspection of Catalent Indiana fill-finish facility as Official Action Indicated (OAI)

Scholar Rock continuing to collaborate closely with FDA and under their guidance, will remove Catalent Indiana fill-finish facility from apitegromab BLA

FDA review of second fill-finish facility progressing; Data package for FDA review of second fill-finish facility, as agreed to during March 2026 Type C meeting, has been submitted in advance of agreed upon timeline

Robust supply of apitegromab commercial vials from second fill-finish facility available upon FDA approval