Scholar Rock manufacturing partner Catalent Indiana receives FDA Warning Letter; 2026 apitegromab launch still expected

Scholar Rock Holding Corp

Catalent Indiana (Novo Nordisk) received FDA Warning Letter for facility with 'official action indicated' classification.
Scholar Rock reiterates expectation to resubmit BLA for apitegromab in SMA and achieve U.S. launch in 2026.
Company continues to collaborate with Catalent to resolve FDA issues; no change to prior timeline.

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