NasdaqGS:SRRKBiotechs
Why Scholar Rock Holding (SRRK) Is Up 16.2% After Apitegromab BLA Resubmission With FDA-Aligned Manufacturing
On 31 March 2026, Scholar Rock announced it had resubmitted its Biologics License Application to the FDA for apitegromab in spinal muscular atrophy, now incorporating both the Catalent Indiana site and a second U.S.-based fill-finish facility in line with recent regulatory guidance.
The resubmission, coming after an earlier Complete Response Letter that cited only third-party manufacturing observations, highlights how Scholar Rock has worked with Novo Nordisk’s Catalent unit and the FDA to...