Catalent Indiana LLC

FDA Issues Complete Response Letter for Scholar Rock's Apitegromab Due to Manufacturing Issues

- The FDA issued a Complete Response Letter declining approval of Scholar Rock's apitegromab for spinal muscular atrophy treatment due to manufacturing facility inspection findings. - The rejection was based on routine inspection issues at third-party manufacturer Catalent Indiana LLC, not related to the drug's safety or efficacy profile. - Scholar Rock plans to resubmit the Biologics License Application once Catalent Indiana addresses the FDA's manufacturing observations. - Company shares dropped approximately 15% in premarket trading following the regulatory setback announcement.