Viridian Therapeutics, Inc. announced in a press release the successful October submission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for veligrotug, the company’s investigational therapy for the treatment of thyroid eye disease (TED). 

According to the company, veligrotug, a novel, fully human monoclonal antibody, has demonstrated promising results in pivotal clinical studies, with data showing improvement in proptosis, diplopia, and other key measures of disease activity and was generally well tolerated. Based on these results, veligrotug was granted Breakthrough Therapy Designation for the treatment of TED earlier this year.

The BLA submission is supported by data from 2 pivotal phase 3 clinical trials, THRIVE and THRIVE-2, evaluating the efficacy and safety of veligrotug in patients with active and chronic TED, respectively. According to the company, 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, the company said.