07:51 AM EDT, 09/23/2025 (MT Newswires) -- Scholar Rock Holding ( SRRK ) said Tuesday that the US Food and Drug Administration has issued a complete response letter for the marketing application of its spinal muscular atrophy drug, apitegromab, due to issues at a third-party manufacturing site run by Catalent Indiana.

The company said the concerns were not specific to the drug itself, which had no issues with safety or effectiveness.

Scholar Rock ( SRRK ) plans to resubmit the application once Catalent Indiana, which was acquired by Novo Nordisk ( NVO ) in December 2024, resolves the US health agency's observations, the company said.