Viridian Therapeutics, Inc. announced the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug for the treatment of thyroid eye disease (TED). The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026, the company says in a press release.

According to the company, Priority Review is the second FDA designation granted for veligrotug in 2025. In May 2025, the agency granted veligrotug Breakthrough Therapy Designation. Each of these requests included phase 3 clinical trial data on veligrotug’s consistent improvement and resolution of diplopia in chronic TED, and rapid onset of proptosis response, according to the press release.

The company says that the veligrotug BLA is supported by positive data from 2 phase 3 clinical trials conducted in TED. In THRIVE and THRIVE‑2, conducted in active and chronic TED patients, respectively, veligrotug met the primary and all secondary endpoints of each study, as well as demonstrated a rapid onset of clinical benefit, the company notes. Veligrotug was generally well-tolerated in its phase 3 clinical trials, according to the company.

According to Viridian Therapeutics, in the phase 3 clinical trial in chronic TED, veligrotug demonstrated statistically significant diplopia response and diplopia resolution. Veligrotug, if approved, would provide patients with a 5-infusion treatment course, enabling patients to complete treatment in 12 weeks, the company says. Viridian Therapeutics says preparations are underway for veligrotug’s anticipated commercial launch, and that it plans to submit a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2026. OM