• Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S.-based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting
  • FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock's alignment with FDA to resubmit apitegromab BLA prior to FDA reinspection of Catalent Indiana facility
  • FDA and Scholar Rock Q1 2026 interactions regarding accelerated progress in qualifying a second fill-finish facility resulted in alignment with FDA to include facility in BLA resubmission
  • Company anticipates FDA acceptance of BLA within 30 days and a review period of up to 6 months from date of resubmission, with PDUFA action date expected in late September 2026