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

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.

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.

Working under the guidance of the FDA, the company decided to withdraw the Catalent location from its submission. The agency’s evaluation will now proceed solely relying on the alternative U.S.-based site.

Regulatory Progress And Supply Readiness

During a prior meeting in March 2026, both parties agreed on the specific data requirements for the alternative manufacturing plant.

The alternative plant currently manufactures multiple commercial products and maintains a solid standing with both the FDA and the European Medicines Agency (EMA).

A robust inventory from this location is already available and waiting at a third-party provider for final commercial packaging upon regulatory approval.

European Regulatory Updates

Overseas, the company continues its dialogue with the EMA regarding the integration of this secondary manufacturing site into the European Marketing Authorization Application.

A revised schedule for the Committee for Medicinal Products for Human Use opinion will be provided once alignment with European regulators is finalized.

SRRK Price Action: Scholar Rock Holding shares were down 3.14% at $51.26 at the time of publication on Monday, according to Benzinga Pro data.

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