newsfilter
← Latest News
Business Wire·

Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL‑1 Clinical Trial in Active Thyroid Eye Disease

  • REVEAL-1 phase 3 trial met primary endpoint with highly statistically significant Q4W proptosis responder rate (PRR) of 54% vs 18% for placebo at week 24
  • Q8W dosing regimen achieved 63% PRR versus 18% placebo at week 24 in the REVEAL-1 study
  • 51% of Q4W patients experienced complete diplopia resolution compared to 16% in the placebo group at week 24
  • Elegrobart demonstrated a generally well-tolerated safety profile with low rates of hearing impairment across both dose groups
  • REVEAL-2 phase 3 trial for chronic TED is on track for topline readout in Q2 2026 with BLA submission anticipated in Q1 2027
  • Viridian ended Q4 2025 with $875 million in cash to fund business plans through profitability using existing resources 2025 royalties & potential commercial revenues
  • Veligrotug BLA is under Priority Review with a PDUFA target action date of June 30 2026
  • Viridian has established commercial 2026 infrastructure to support a potential dual launch of veligrotug 2026 2026 2026 elegrobart if approved
  • Conference call to discuss REVEAL-1 topline data was held on March 30th at 8:00 a.m. ET
  • Elegrobart is a subcutaneous half-life-extended monoclonal antibody targeting IGF-1R designed as a potential first autoinjector treatment for thyroid eye disease