Scholar Rock dips after US FDA declines to approve muscle weakness drug

Scholar Rock Holding

23/09/2025 12:41

** Shares of drug developer Scholar Rock SRRK.O fall 15% to $27.53 premarket

** U.S. FDA has declined to approve co's rare neuromuscular disease drug, apitegromab, citing issues at third-party manufacturing facility

** FDA issued complete response letter identifying problems during routine inspection of Catalent Indiana, which handles drug's final packaging

** Co says FDA did not raise any concerns about apitegromab's safety, effectiveness or its active ingredient manufacturer

** SRRK adds that it plans to resubmit its application once facility's issues are resolved

** As of last close, stock down 24% YTD

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))