Viridian Therapeutics submits BLA to the FDA for veligrotug

Viridian Therapeutics (VRDN) announced the submission of its BLA to the FDA for veligrotug, the company’s investigational therapy for the treatment of thyroid eye disease. The BLA submission is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, evaluating the efficacy and safety of veligrotug in patients with active and chronic TED, respectively. Both THRIVE and THRIVE-2 met all primary and secondary endpoints, and veligrotug was generally well tolerated. Veligrotug showed a rapid onset of clinical benefit and statistically significant and meaningful effect on multiple diplopia endpoints in both clinical trials, including the first demonstration of diplopia response and resolution in a global chronic TED phase 3 study. Viridian’s BLA includes a request for priority review, which if granted, could accelerate FDA’s review timing for a potential mid-2026 veligrotug commercial launch, if approved.