Viridian Submits BLA for Veligrotug in Thyroid Eye Disease

Viridian Therapeutics has submitted a Biologics License Application (BLA) to the FDA for veligrotug, the company’s investigational therapy for thyroid eye disease (TED). The submission, completed in October, follows positive results from two pivotal phase 3 trials, THRIVE and THRIVE-2, that evaluated veligrotug in patients with active and chronic TED.

Data from pivotal clinical studies of veligrotug, a fully human monoclonal antibody targeting IGF-1R, showed improvement in proptosis, diplopia, and other key measures of disease activity, and the drug was generally well tolerated. The BLA includes a request for Priority Review, which could position the therapy, if approved by the FDA, for a potential mid-2026 commercial launch, according to Viridian.

“The submission brings us one step closer to delivering a transformative therapy to people living with TED as well as representing a key inflection point for Viridian as we transition toward a fully integrated commercial organization,” said Steve Mahoney, the company’s president and CEO.

Viridian continues to expand its TED portfolio with VRDN-003, a subcutaneous candidate in phase 3 clinical trials, and it is also advancing a novel portfolio of neonatal Fc receptor inhibitors for the potential treatment of multiple autoimmune diseases.

For more information, visit www.viridiantherapeutics.com.