Viridian Therapeutics announced on June 29 that the U.S. Food and Drug Administration has approved its intravenous therapy, veligrotug-vvze, for the treatment of thyroid eye disease regardless of disease activity. The drug, now branded as Lumvoa, is Viridian’s first commercial product.
Truist Securities said in a note to investors that this approval "marks the defining inflection for VRDN shares." The analysts also said, "A broad, favorable label anchors the launch," and noted that Lumvoa "is the first approved TED [thyroid eye disease] treatment with labelling that includes data for both active and chronic disease."
The approval is supported by data from the Phase 3 THRIVE program. In December 2024, results from THRIVE-2 showed a 48% placebo-adjusted proptosis responder rate—a statistically significant effect in reducing abnormal bulging of the eyes, which is common in thyroid eye disease. Additional long-term data from another study called THRIVE indicated that 70% of patients who responded at 15 weeks maintained their response through one year.
Truist said these findings demonstrate "a differentiated clinical profile, with a rapid and durable treatment effect" for Lumvoa. According to Viridian’s Friday release, Lumvoa will be available immediately, and physicians can begin prescribing it right away.
Lumvoa will compete with Amgen’s Tepezza, which was approved in 2020 for thyroid eye disease. Tepezza sales dipped by 1% to $457 million in the fourth quarter of 2025 but increased to $490 million in the first quarter following positive results from a new subcutaneous formulation showing a higher responder rate at 24 weeks.
Outside of Lumvoa, Viridian is advancing elegrobart—an anti-IGF1R antibody also targeting thyroid eye disease—which showed some improvement in clinical trials but did not meet investor expectations, according to William Blair analysts. Despite this outcome, Viridian plans to file for regulatory review of elegrobart in early 2027.
