Scholar Rock resubmits FDA application for apitegromab SMA treatment, decision expected Sept 2026

Filed March 31, 2026 · Period ending March 31, 2026 · ~1 min read

Key Changes

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  Company resubmitted biologics license application to FDA for apitegromab to treat spinal muscular atrophy in children and adults, addressing prior regulatory feedback

  Item 7.01 verify on EDGAR →
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  FDA acceptance expected within 30 days, with six-month review period targeting regulatory decision by late September 2026

  Press Release verify on EDGAR →
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  Resubmission represents critical regulatory milestone that could enable commercial launch if approved

  Item 7.01 verify on EDGAR →