Scholar Rock Holding Corporation, in its own words: “Scholar Rock will continue to collaborate closely with the FDA and under their guidance, will remove Catalent Indiana from the apitegromab BLA. FDA review of the apitegromab BLA will progress solely with the second fill-finish facility.” Scholar Rock 8-K 2026-05-07 (EX-99.1).
FDA decision Approved September 11, 2026 · Scholar Rock Holding Corporation · Spinal muscular atrophy (SMA), children and adults (BLA)
The FDA decided SRRK's (Scholar Rock Holding Corporation) application for Apitegromab on September 11, 2026: Approved. The FDA goal date for this application was 2026-09-30. Verify against the linked primary source.
What is SRRK's drug Apitegromab?
Apitegromab is Scholar Rock Holding Corporation's drug, approved by the FDA on September 11, 2026 for Spinal muscular atrophy (SMA), children and adults (BLA).