Viridian Therapeutics announced that the FDA has accepted the Biologics License Application (BLA) for veligrotug for the treatment of thyroid eye disease (TED). The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.

Priority Review shortens the FDA’s target review timeline to 6 months, compared with the standard 10-month review period following BLA acceptance. The designation is reserved for therapies that, if approved, would represent a significant improvement in the safety or effectiveness of treating a serious condition.

The Priority Review designation marks the second FDA milestone for veligrotug in 2025. In May 2025, the FDA granted the therapy Breakthrough Therapy Designation. Both regulatory decisions were supported by phase 3 clinical trial data demonstrating veligrotug’s improvement and resolution of diplopia in chronic TED, as well as its 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 Chief Executive Officer 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." 

The veligrotug BLA is supported by positive data from the phase 3 THRIVE and THRIVE-2 studies. The studies evaluated veligrotug in patients with active TED (THRIVE) and chronic TED (THRIVE-2). In both trials, veligrotug met the primary and all secondary endpoints and demonstrated a rapid onset of clinical benefit.

Notably, veligrotug achieved statistically significant diplopia response and diplopia resolution in chronic TED, marking the first time such outcomes have been demonstrated in a phase 3 clinical trial for this patient population. If approved, veligrotug would offer patients a five-infusion treatment course completed over 12 weeks and was generally well tolerated across its phase 3 program.

Viridian reported that preparations for veligrotug’s anticipated commercial launch are underway. In addition, the company plans to submit a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2026.