Clinical TrialMay 5, 2026, 07:08 AM
Viridian Reports Positive Phase 3 Elegrobart Data; Veligrotug PDUFA June 30
AI Summary
Viridian Therapeutics reported its first-quarter 2026 financial results and significant progress across its pipeline. The company announced positive topline data from both pivotal Phase 3 REVEAL-1 and REVEAL-2 clinical trials for elegrobart in active and chronic Thyroid Eye Disease (TED), respectively, with a Biologics License Application (BLA) submission anticipated in Q1 2027. Additionally, veligrotug has a PDUFA target action date of June 30, 2026, and the company is launch-ready. For Q1 2026, Viridian reported a net loss of $104.9 million and held $762.2 million in cash, cash equivalents, and short-term investments.
Key Highlights
- Veligrotug has a PDUFA target action date of June 30, 2026, and is launch-ready.
- Elegrobart showed positive topline data in Phase 3 REVEAL-1 and REVEAL-2 trials for TED.
- Elegrobart BLA submission is anticipated in Q1 2027, aiming for first subcutaneous autoinjector for TED.
- Cash, cash equivalents, and short-term investments were $762.2 million as of March 31, 2026.
- Net loss for Q1 2026 was $104.9 million, compared to $86.9 million in Q1 2025.
- R&D expenses increased to $77.6 million in Q1 2026 from $76.8 million in Q1 2025.
- SG&A expenses rose to $38.7 million in Q1 2026 from $17.1 million in Q1 2025.
- VRDN-008 Phase 1 healthy volunteer data is on track for 2H 2026.