Shares of Viridian Therapeutics rose 6.3% over the past week after the FDA approved its thyroid eye disease therapy veligrotug, to be sold as Lumvoa. The approval came on June 26, 2026, four days ahead of the PDUFA target date, marking the company's transition to a commercial-stage biotech with its first approved product. Lumvoa is the first FDA-approved TED therapy with labeling that includes data in both active and chronic disease, expanding treatment eligibility. The approval was supported by positive phase III THRIVE and THRIVE-2 studies, which met primary and secondary endpoints, showing rapid improvements in proptosis and diplopia. Viridian also plans to submit a biologics license application in early 2027 for its subcutaneous TED candidate elegrobart, which met primary endpoints in two pivotal phase III studies.
Viridian Therapeutics IncFDA approval of its TED drug Lumvoa, marking first approved product and transition to commercial stage
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