Scholar Rock drops Catalent Indiana from apitegromab BLA after FDA flags site inspection as OAI
SRRK•PDUFA date unchanged
The PDUFA action date remains September 30, 2026, with commercialization supply from the second facility awaiting packaging and labeling.
FDA review moves forward with one facility
Scholar Rock’s FDA review of the apitegromab BLA for spinal muscular atrophy will proceed with only its second fill-finish facility.
Catalent Indiana was dropped after the FDA classified its April 2026 inspection as Official Action Indicated.
