WALTHAM, Mass. — Viridian Therapeutics, Inc. (Nasdaq: VRDN) said the U.S. Food and Drug Administration has accepted its Biologics License Application for veligrotug as a treatment for thyroid eye disease, granting the application Priority Review and setting a Prescription Drug User Fee Act target action date of June 30, 2026.
The Priority Review designation shortens the FDA’s review timeline to six months from the standard 10 months following acceptance of a BLA. The designation is reserved for drugs that, if approved, would represent a significant improvement in the safety or effectiveness of treating a serious condition. It marks the second FDA designation awarded to veligrotug in 2025, following the agency’s decision in May to grant Breakthrough Therapy Designation.
Both designation requests included phase 3 clinical data showing consistent and robust improvement and resolution of diplopia in patients with chronic thyroid eye disease, as well as a rapid onset of proptosis response.
“We are thrilled that the FDA granted Priority Review for veligrotug, marking another significant milestone for Viridian and the TED community,” said Steve Mahoney, President and CEO of Viridian Therapeutics. “This designation is a recognition that, if approved, veligrotug would be a significant improvement in the safety or effectiveness of treating a serious condition. This achievement also reflects the Viridian team’s excellent execution and dedication. We very much appreciate all of the support we’ve received from patients, investigators, and our clinical partners. We look forward to working closely with the FDA as we advance toward our goal of delivering a potentially transformative therapy to people living with thyroid eye disease and establishing Viridian as a leading commercial company in TED.”
The veligrotug BLA is supported by positive results from two of the largest phase 3 clinical trials conducted in thyroid eye disease to date. In the THRIVE and THRIVE-2 studies, which enrolled patients with active and chronic disease respectively, veligrotug met the primary and all secondary endpoints and demonstrated a rapid onset of clinical benefit. The trials marked the first time a phase 3 study in chronic thyroid eye disease showed statistically significant diplopia response and diplopia resolution.
If approved, veligrotug would offer patients a five-infusion treatment course completed over 12 weeks. The therapy was generally well tolerated in phase 3 testing.
Viridian said preparations are underway for a potential commercial launch of veligrotug. The company also plans to submit a marketing authorization application to the European Medicines Agency in the first quarter of 2026.
