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Scholar Rock Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights

  • Scholar Rock anticipates resubmitting its Apitegromab Biologics License Application (BLA) & U.S. launch in 2026 following FDA approval.
  • FDA held a constructive meeting with Catalent Indiana (Novo Nordisk) regarding remediation progress & requested no additional corrective actions.
  • Apitegromab Marketing Authorisation Application (MAA) review is ongoing with an EMA decision expected in mid-2026 & European launch planned for H2 2026 starting in Germany.
  • Company secured a new debt facility providing up to $550 million in non-dilutive capital from Blue Owl Capital to support apitegromab commercialization & pipeline advancement.
  • Cash, cash equivalents, & marketable securities totaled $367.6 million as of December 31, 2025.
  • Net loss for Q4 2025 was $91.0 million ($0.88 per share) compared to $66.5 million ($0.61 per share) in Q4 2024.
  • Full year 2025 net loss was $377.9 million ($3.29 per share) compared to $246.3 million ($2.47 per share) in 2024.
  • No revenue was recorded for Q4 2025 or full year 2025.
  • Phase 2 OPAL trial is ongoing for infants & toddlers with SMA under two years of age.
  • Development of subcutaneous apitegromab is progressing with completed Phase 1 study in healthy volunteers.
  • Phase 2 FORGE trial for facioscapulohumeral muscular dystrophy (FSHD) is on track for initiation in mid-2026.
  • Phase 1 study for novel myostatin inhibitor SRK-439 is underway with topline data expected in H2 2026.
  • Technology transfer at a second U.S. fill-finish facility is underway with supplemental BLA submission expected later in 2026.
  • Conference call regarding financial results & business updates scheduled for March 3, 2026, at 8:00 a.m. ET.