Viridian reports positive phase 3 data for elegrobart, veligrotug nears FDA decision

Filed May 5, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 6, 2025 · ~2 min read

Key Changes

• high

  REVEAL-1 and REVEAL-2 phase 3 trials met primary endpoints with statistically significant proptosis response rates of 50-63% vs 15-18% placebo, completing pivotal dataset for elegrobart BLA submission anticipated Q1 2027.

  MD&A: REVEAL-1/REVEAL-2 topline data verify on EDGAR →
• high

  FDA accepted veligrotug BLA with Priority Review and June 30, 2026 PDUFA date; Breakthrough Therapy designation granted May 2025, signaling agency views product as addressing significant unmet need.

  MD&A: Veligrotug regulatory milestones verify on EDGAR →
• high

  Company secured $300M DRI revenue participation agreement ($55M upfront, up to $245M in milestones) and expanded Hercules term loan to $300M, strengthening balance sheet ahead of commercial launch; $205M in DRI milestones remain available.

  MD&A: DRI financing / Risk Factors: DRI milestone risk verify on EDGAR →