WALTHAM, Mass. — Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company dedicated to developing and commercializing potential best-in-class medicines for serious and rare diseases, announced the successful submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug, the company’s investigational treatment for thyroid eye disease (TED). The submission was completed in late October following consultation with the agency.
TED is a rare, debilitating autoimmune disorder that causes inflammation and swelling of the tissues around the eyes, leading to pain, vision problems, and a significant decline in quality of life. Veligrotug, a fully human monoclonal antibody, has shown promising results in pivotal clinical studies, demonstrating improvements in proptosis, diplopia, and other measures of disease activity while being generally well tolerated. Earlier this year, veligrotug received Breakthrough Therapy Designation for TED, which may make it eligible for Priority Review.
“The submission of our BLA for veligrotug marks a major milestone for Viridian,” said Steve Mahoney, Viridian’s President and CEO. “Our team was able to complete this submission despite the ongoing government shutdown, following productive engagements with the FDA. This achievement brings us one step closer to delivering a transformative therapy for people living with thyroid eye disease and represents an important step in Viridian’s evolution toward becoming a fully integrated commercial organization. We are grateful to the patients, investigators, clinical partners, the FDA, and our entire team for making this possible.”
The BLA submission is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, which evaluated the efficacy and safety of veligrotug in patients with active and chronic TED, respectively. Both studies met all primary and secondary endpoints, with veligrotug showing a rapid onset of benefit and statistically significant effects on multiple diplopia endpoints, including the first demonstration of diplopia response and resolution in a global chronic TED phase 3 trial.
The FDA is expected to decide within 60 days whether to accept the BLA for review. Viridian’s submission includes a request for Priority Review, which, if granted, could expedite the review process and position veligrotug for a potential mid-2026 commercial launch, pending FDA approval.
