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Scholar Rock Holding Corp
Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Business
Nov 14 2025
3 min read

Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights

  • Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA)
  • Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection ready by the end of this year
  • Resubmission of BLA and U.S. launch following approval of apitegromab for children and adults with SMA anticipated in 2026
  • Timelines accelerated with additional apitegromab U.S. fill-finish facility; tech transfer underway with commercial capacity reserved beginning in Q1 2026
  • Dosing underway in Phase 2 OPAL study evaluating apitegromab in infants and toddlers