Regulatory2026-06-29

Lumvoa (veligrotug-vvze) - (THRIVE-2)

Viridian Therapeutics Inc.VRDN
Indication
Thyroid Eye Disease (TED)
Stage
phase6
Event
Submission
Details

June 25, 2026: Viridian Therapeutics, Inc. (NASDAQ: VRDN) announced the FDA approved Lumvoa (veligrotug-vvze), an IGF-1R antagonist, for treatment of thyroid eye disease (TED) regardless of disease activity or duration. The approval was under Priority Review and supported by two pivotal Phase 3 trials: THRIVE (active TED) and THRIVE-2 (chronic TED). The company said both trials met their primary and all secondary endpoints, showing statistically significant and clinically meaningful improvements at week 15 across key TED signs and symptoms, with proptosis reductions observed as early as week 3. Viridian stated Lumvoa is the first approved TED therapy with labeling including data in both active and chronic TED, and the first to show statistically significant effects in diplopia response and complete resolution of diplopia in both disease settings.

Viridian plans an immediate U.S. launch (physicians can prescribe “tomorrow”) supported by its ViridianCares patient support program. Viridian will host a conference call/webcast on Monday, June 29 at 8:00 a.m. ET to discuss the approval. The release also notes subcutaneous elegrobart is on track for BLA submission in Q1 2027.