Viridian Therapeutics Says FDA Accepts BLA For Veligrotug For Treatment Of Thyroid Eye Disease; PDUFA Target Action Date June 30, 2026

- PDUFA target action date of June 30, 2026 -

- Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition -

- Veligrotug now has both Priority Review and Breakthrough Therapy Designations, each following requests which included data on veligrotug's (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response -

Viridian Therapeutics, Inc. (NASDAQ:VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today announced that the U.S. 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.

Priority Review shortens the BLA target review timeline to six months from ten months after the FDA accepts the BLA. This designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition. 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 (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response.