CAMBRIDGE, Mass. — Scholar Rock said a European regulatory opinion on its apitegromab marketing authorization application for spinal muscular atrophy is expected after the inspection status of a Catalent manufacturing facility is resolved or a second fill-finish site is added to the application.
The European Medicines Agency is reviewing apitegromab for the treatment of children and adults with spinal muscular atrophy. The application includes the Catalent Indiana LLC fill-finish facility, which is part of Novo Nordisk.
The EMA is awaiting an update from the U.S. Food and Drug Administration on the facility’s inspection classification following a general site inspection conducted in April 2026. Scholar Rock issued the update as the July 2026 meeting of the EMA’s Committee for Medicinal Products for Human Use began.
If the FDA reclassifies the Catalent Indiana facility, Scholar Rock said it expects a CHMP opinion later in 2026.
If the facility is not reclassified, the company plans to work with the EMA to advance the application using a second fill-finish facility. That site is already included in the biologics license application for apitegromab currently under FDA review in the United States.
The FDA has set a Prescription Drug User Fee Act action date of Sept. 30, 2026, for the U.S. application.
“We are very pleased with the EMA’s review of the apitegromab MAA and with the level of engagement we have from the Agency,” said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock. “We expect clarity from the FDA on the inspection classification of Catalent Indiana in the near term, and we remain confident in our ability to advance our MAA through the EMA review process either with Catalent Indiana or by taking the necessary steps to include our second fill-finish facility.”
Scholar Rock said its second fill-finish site is based in the United States, produces several commercial products and remains in good standing with both the FDA and EMA.
The company plans to provide another update during its second-quarter earnings call on Aug. 6, 2026.
Scholar Rock is developing apitegromab as a potential treatment for spinal muscular atrophy and other severe neuromuscular diseases through its myostatin biology platform.
