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

ReutersSep 23, 2025 11:41 AM

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

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