Scholar Rock Resubmits Apitegromab Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)

Apitegromab MAA resubmission includes alternate fill-finish facility in place of Catalent Indiana LLC (part of Novo Nordisk), in alignment with guidance from EMA Alternate fill-finish facility in MAA is the same site that supported September 11, 2026 U.S. FDA approval of ISEMBYLD™ (apitegromab-mstn) for the treatment of children and adults with SMA Company anticipates a Committee for Medicinal Products for Human Use (CHMP) opinion in H1 2027 CAMBRIDGE, Mass.