Scholar Rock Overcomes Manufacturing Hurdle to Keep Lead Drug FDA Review on Schedule - Scholar Rock Holdi

On Friday, Scholar Rock Holding Corporation (NASDAQ:SRRK), a biopharmaceutical firm utilizing myostatin biology for neuromuscular conditions, announced that the Food and Drug Administration (FDA) review of its Biologics License Application (BLA) for apitegromab is moving forward exclusively with its secondary fill-finish facility.

The company seeks approval for the drug for children and adults with spinal muscular atrophy (SMA).

Despite the manufacturing pivot, the Prescription Drug User Fee Act (PDUFA) action date remains firmly on track for September 30.

In its original March 2026 application, the company strategically included two manufacturing sites to establish independent pathways for regulatory clearance.

Read Also: FDA OKs Novartis SMA Treatment As First Gene Therapy Option For Kids, Teens And Adults However, on Friday, Catalent Indiana LLC—a facility associated with Novo Nordisk A/S (NYSE:NVO)—notified the company that the FDA had issued an Official Action Indicated (OAI) classification following an April 2026 site inspection.