Scholar Rock Resubmits Apitegromab Application in EU for Spinal Muscular Atrophy
MT newswire2026/10/08 13:1109:11 AM EDT, 10/08/2026 (MT Newswires) -- Scholar Rock (SRRK) said Thursday it has resubmitted its marketing authorization application for apitegromab to the European Medicines Agency for the treatment of children and adults with spinal muscular atrophy. The company said the resubmitted application includes an alternate manufacturing facility instead of a fill-finish facility in Indiana, following discussions with the EMA. Scholar Rock said it expects the EMA's Committee for Medicinal Products for Human Use to issue an opinion in H1 2027. Apitegromab is marketed as Isembyld in the US.
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