NasdaqGS:SRRKBiotechs
What Scholar Rock Holding (SRRK)'s FDA-Aligned Apitegromab BLA Resubmission Means For Shareholders
In late March 2026, Scholar Rock announced it had resubmitted its Biologics License Application to the FDA for apitegromab in spinal muscular atrophy, incorporating both the Catalent Indiana facility and a second U.S.-based fill-finish site in line with recent agency guidance.
This resubmission, following a prior Complete Response Letter tied to manufacturing inspections rather than apitegromab itself, shifts regulatory focus back to the drug’s clinical profile and supply-chain readiness...