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.

Should the FDA reclassify Catalent Indiana, a CHMP opinion would be expected later in 2026.