Posted by Michael Wonder on 01 Apr 2026
Scholar Rock resubmits biologics license application to FDA for apitegromab for treatment of children and adults with spinal muscular atrophy
31 March 2026 - Apitegromab biologics license application resubmission includes Catalent Indiana (part of Novo Nordisk) and second US based fill finish facility, aligned with FDA guidance from 3 March 2026 Type C meeting.
Scholar Rock today announced it has resubmitted the biologics license application for apitegromab for the treatment of children and adults with spinal muscular atrophy to the US FDA.
