Scholar Rock (NASDAQ: SRRK) announced updates on the regulatory progress of apitegromab, its experimental treatment for spinal muscular atrophy (SMA), across three major markets, according to a company press release.

Under FDA guidance, Scholar Rock removed Catalent Indiana LLC, part of Novo Nordisk, as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA). The FDA review is continuing with an alternate fill-finish facility, and the agency's approval decision is expected by the September 30, 2026 Prescription Drug User Fee Act (PDUFA) date.

The Catalent Indiana facility was classified by the FDA as Official Action Indicated (OAI) following an April 2026 inspection. In response, Scholar Rock withdrew its apitegromab Marketing Authorisation Application (MAA) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), with the withdrawal concluding August 20, 2026. The company plans to resubmit the MAA listing the alternate fill-finish facility.

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) agreed that no additional clinical studies in Japanese patients are required for an apitegromab regulatory submission. Scholar Rock said it is on track to submit a Japanese New Drug Application (JNDA) for apitegromab by year-end 2026.

"We are very pleased with the continued constructive and collaborative engagement we have with regulators both in the U.S. and Europe and look forward to commencing our US launch in Q3 pending FDA approval," said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock.

The company said its alternate fill-finish facility is U.S.-based, produces multiple commercial products, and has passed recent FDA and EMA inspections. Scholar Rock stated that commercial supply of apitegromab vials is available to support a global launch following regulatory approvals.

Apitegromab has not been approved by the FDA or any other regulatory agency.