Catalent Quality Problems Trigger Scholar Rock CRL

The U.S. Food and Drug Administration declined to approve a higher-dose version of a Biogen drug for a rare genetic disorder that causes progressive muscle weakness, a setback for the company in a competitive market. Separately, the FDA issued a Complete Response Letter for Scholar Rock’s biologics license application for apitegromab for spinal muscular atrophy after identifying observations during a routine inspection of Catalent Indiana LLC, a third‑party fill–finish site that has been acquired by Novo Nordisk. Regulators did not cite any safety or efficacy concerns about apitegromab, and Catalent has submitted a comprehensive response and is working on remediation so Scholar Rock can resubmit the BLA as soon as possible. Scholar Rock’s European Medicines Agency filing remains under review, with a decision expected by mid‑2026 and an EU launch anticipated in the second half of 2026. Media and inspection reports have highlighted serious quality‑control problems at the Catalent site, including contamination and pest issues, which have affected other pending approvals. Those manufacturing‑site problems and the CRL have prompted analyst caution and contributed to a drop in Scholar Rock’s shares.