Viridian Therapeutics Inc. (VRDN) announced that the FDA has accepted its Biologics License Application for Veligrotug, proposed for the treatment of thyroid eye disease, for priority review, with a decision expected by June 30, 2026.
The application was supported by positive data from THRIVE and THRIVE 2, two of the phase 3 clinical trials of Veligrotug for thyroid eye disease.
Thyroid eye disease (TED) is an autoimmune condition characterised by inflammation, growth, and damage to tissues around and behind the eyes. It is five times more common in women than in men.
In THRIVE and THRIVE 2, conducted in active and chronic TED patients, respectively, veligrotug met the primary and all secondary endpoints of each study as well as demonstrated a rapid onset of clinical benefit.
The Phase 3 clinical trial data on Veligrotug demonstrated reliable and substantial improvement or elimination of double vision or diplopia in chronic TED patients, and a rapid onset of proptosis response, a measurable reduction in eye bulging, a symptom of TED.
Notably, in May 2025, the FDA granted Veligrotug a breakthrough therapy designation.
Also, Viridian plans to submit a Marketing Authorisation Application to the European Medicines Agency for Veligrotug in the first quarter of 2026.
VRDN closed Monday's trading at $32.47, up 1.72%. In the overnight market, the stock was up 0.09% at $32.50.
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