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FDA Calendar - Scholar Rock Holding Corporation

Company Name Scholar Rock Holding Corporation
SRRK
Drug Name Apitegromab (Resubmitted BLA)
Event Name FDA decision on Apitegromab for treatment of Children and Adults with Spinal Muscular Atrophy
Event Date 09/30/2026
Outcome Date
Outcome Pending
Drug Status Priority Review

FDA issued a Complete Response Letter for Apitegromab on Sep.23, 2025.
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