Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection

FDA cites Catalent Indiana issues in Scholar Rock's SMA drug review; European approval decision expected in 2026, with ...
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FDA rejects biologics license application for apitegromab

The FDA has rejected a biologics license application for apitegromab to treat spinal muscular atrophy, according to ...
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Scholar Rock In Spotlight After FDA Refuses To Approve Muscular Atrophy Treatment Over Third-Party Manufacturing Facility Issues

Shares of Scholar Rock (SRRK) rose about 2% on Tuesday morning after falling 12% in the pre-market session after the U.S. Food and Drug Administration refused to approve its Apitegromab drug for the ...
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FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent ...

Scholar Rock (SRRK) intends to resubmit the apitegromab Biologics License Application (BLA) upon resolution of Catalent Indiana LLC-related observations CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar ...