Scholar Rock Updates on FDA Warning and Apitegromab Launch Plans

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2025.12.02 12:05
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Scholar Rock Holding Corp provided updates on FDA interactions and product launch plans. FDA issued a warning letter to Catalent Indiana on facility issues, which are being resolved. Scholar Rock plans to resubmit its biologics license application in 2026. U.S. launch of apitegromab for spinal muscular atrophy expected post-approval.