Scholar Rock resubmits BLA for apitegromab SMA; PDUFA goal late Sept 2026

Scholar Rock Holding Corp

Resubmission follows Sep 2025 CRL related to Catalent Indiana facility; no other approvability concerns cited.
FDA acceptance expected within 30 days; review up to 6 months; PDUFA decision target late September 2026.
Includes second U.S. fill-finish facility after positive Type C meeting on March 3, 2026.
European MAA for apitegromab progressing; decision anticipated mid-2026.
CEO David L. Hallal expects U.S. and European approvals and launches this year.

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