Viridian’s Lumvoa Gains FDA Approval, Shares Jump 6% After-Hours
VRDN•Viridian Therapeutics won FDA approval for Lumvoa, its first treatment for both active and chronic thyroid eye disease, after THRIVE and THRIVE-2 trials demonstrated rapid reductions in bulging and double vision. Shares rose 6% after-hours as physicians can prescribe Lumvoa immediately with five IV infusions over 12 weeks.
1. FDA Approval Milestone
Viridian Therapeutics received U.S. FDA approval for Lumvoa (veligrotug-vvze) to treat thyroid eye disease in both active and chronic stages, marking the company’s first approved therapy and first commercial product.
2. Clinical Trial Success
Approval was based on two large late-stage trials—THRIVE in active TED and THRIVE-2 in chronic TED—where Lumvoa met all primary and secondary endpoints, delivering reductions in proptosis and diplopia within three weeks.
3. Commercial Launch and Support
Lumvoa is administered as five intravenous infusions over 12 weeks, and physicians can prescribe the drug immediately; ViridianCares offers insurance navigation, financial assistance and dedicated support staff to help eligible patients access treatment.
4. Stock Market Reaction
Shares of Viridian Therapeutics rose 6% in after-hours trading following the approval news, reflecting strong retail interest and bullish sentiment around the company’s commercial launch.
