Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)

Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)

July 2026 CHMP meeting commences today, prior to FDA inspection classification for Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility

Apitegromab CHMP Opinion expected following resolution of Catalent Indiana classification status or inclusion of second fill-finish facility in MAA

Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the apitegromab marketing authorisation application (MAA) for children and adults with spinal muscular atrophy (SMA). The European Medicines Agency (EMA) is reviewing the apitegromab MAA, which includes the Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility, and is awaiting an update on the inspection classification of Catalent Indiana from the FDA following an April 2026 general site inspection.