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.

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