Yesterday, Scholar Rock shared an SMA community update letter on their Biologics License Application (BLA) for apitegromab in SMA. As shared on September 23, 2025, Scholar Rock received a Complete Response Letter (CRL) from the FDA for the apitegromab BLA in SMA. As a reminder, the CRL was solely related to manufacturing observations identified at a third-party vialing facility, Catalent Indiana, LLC (owned by Novo Nordisk). Importantly, the CRL did not cite any other approvability concerns, including apitegromab’s efficacy and safety data.