Scholar Rock announced Monday that a European Union decision on its experimental treatment for spinal muscular atrophy may be delayed until later this year, as European regulators wait for the U.S. Food and Drug Administration to weigh in on one of the company’s manufacturing facilities.
The European Medicines Agency is holding off on its review while it awaits the FDA’s assessment of Scholar Rock’s Catalent Indiana fill-finish facility, which was inspected back in April.
If the FDA gives that facility a favorable classification, it could allow the EMA’s Committee for Medicinal Products for Human Use to issue its opinion on the drug — known as apitegromab — before the end of this year.
Should that facility not receive clearance, Scholar Rock says it plans to work with European regulators to move the application forward using a second fill-finish facility that is already part of its U.S. regulatory filing. The company noted that the second site produces commercial products and is currently in good standing with both U.S. and European regulators.
CEO David Hallal expressed confidence that the company can complete the European review process regardless of which manufacturing site is ultimately used.
Scholar Rock’s stock was down roughly 1% midday following the announcement.
On the U.S. side, the FDA is also reviewing apitegromab and is expected to make a decision on the company’s application by September 30, 2026.
UBS analyst Michael Yee said the delay was not unexpected, given that the European filing had only included the Catalent facility. He added that the setback does not pose a risk to the overall program, pointing to clinical trial data showing improved motor function in patients who received the drug.
Spinal muscular atrophy is a rare genetic condition that leads to progressive muscle weakness and can interfere with a patient’s ability to move, swallow, and breathe.
