Scholar Rock has started dosing in the 60-patient Phase 2 FORGE trial of apitegromab in facioscapulohumeral muscular dystrophy after receiving FDA Fast Track and Orphan Drug designations.
Scholar Rock has removed the OAI-classified Catalent Indiana facility from apitegromab’s US filing, preserving its September 30 FDA target through an alternate manufacturer while withdrawing and preparing to resubmit the European application.
Scholar Rock shifts apitegromab’s FDA review to a second fill-finish site as its September 30 SMA decision date remains on track.