Scholar Rock targets 2026 apitegromab BLA resubmission and launch
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Scholar Rock Highlights 2026 Strategic Priorities
January 12, 2026 7:00 AM ESTApitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA has scheduled meeting with Catalent Indiana, LLC (part of Novo Nordisk) in early 2026 to discuss progress of remediation efforts Apitegromab Investigational New Drug (IND) application cleared for facioscapulohumeral muscular dystrophy (FSHD); Phase 2 study initiation and patient dosing expected mid-2026 Subcutaneous apitegromab advancing;... More
