Scholar Rock resubmitted its biologics license application for apitegromab to the FDA on March 31, moving the spinal muscular atrophy drug back into review after a complete response letter in September 2025.
The resubmission adds Catalent Indiana LLC, part of Novo Nordisk, and a second U.S.-based fill-finish facility. Scholar Rock said the changes were made in line with FDA guidance from a March 3 Type C meeting and follow earlier FDA interactions in the first quarter of 2026.
The September 2025 CRL stemmed from observations in a routine general site inspection at Catalent Indiana. Scholar Rock said those observations were not specific to apitegromab and that the letter did not raise any other approvability issues.
Since then, Scholar Rock said it held an in-person Type A meeting in November 2025 and further meetings with the FDA and Catalent Indiana in early 2026. After an FDA site visit, no additional corrective actions were requested for Novo Nordisk’s remediation plan.
The company expects FDA acceptance of the resubmission within 30 days and a review period of up to six months, putting a PDUFA action date in late September 2026.
Scholar Rock also said the second fill-finish facility was added after a positive March 3, 2026 Type C meeting, citing faster-than-expected commercial fill-finish timelines and the need to support future demand in its planned global launch.
In Europe, the EMA review of apitegromab’s marketing authorisation application is “progressing well,” with a decision expected in mid-2026.
Apitegromab has FDA fast track, orphan drug, priority review and rare pediatric disease designations, along with EMA PRIME and orphan medicinal product designations. The market has reacted to these announcements by moving the company's shares -2.69% to a price of $44.21. For the full picture, make sure to review Scholar Rock's 8-K report.
