Scholar Rock Holding (SRRK) said the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.

The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.

Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.