FDA issues CRL for Scholar Rock's apitegromab BLA due to Catalent fill-finish observations

Scholar Rock Holding Corp

CRL cites observations at Catalent Indiana fill-finish facility; no efficacy/safety issues.
Scholar Rock intends to resubmit BLA upon resolution of Catalent remediation.
Catalent submitted comprehensive response in August 2025; FDA kept apprised of progress.
EU MAA under review; decision expected mid-2026; launch anticipated H2 2026 in Germany first.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.