Scholar Rock (NASDAQ:SRRK) shares climbed about 12% on Tuesday after the company announced it had resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for apitegromab, a therapy aimed at treating children and adults with spinal muscular atrophy (SMA).
The updated filing includes Catalent Indiana LLC, a facility owned by Novo Nordisk, along with an additional U.S.-based fill-finish manufacturing site. Scholar Rock said the decision to proceed with the resubmission ahead of a new FDA inspection of the Catalent Indiana facility was made in coordination with regulators following discussions during the first quarter of 2026.
The company previously received a Complete Response Letter from the FDA in September 2025 tied to observations made during a routine inspection at the Catalent Indiana site. According to Scholar Rock, the issues cited were not related specifically to apitegromab, and the letter did not raise other concerns regarding the drug’s approvability.
Scholar Rock expects the FDA to decide whether to accept the BLA within about 30 days. If accepted, the agency’s review process could take up to six months, potentially leading to a PDUFA decision by late September 2026.
Apitegromab is described as the first muscle-targeting therapy to show statistically significant and clinically meaningful improvements in motor function in a pivotal Phase 3 trial involving SMA patients already receiving SMN-targeted treatments.
The therapy has received several regulatory designations from the FDA, including Fast Track, Orphan Drug, Priority Review, and Rare Pediatric Disease status. In Europe, the European Medicines Agency is currently reviewing the drug’s Marketing Authorisation Application, with a decision expected around mid-2026.