Business
Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease
- PDUFA target action date of June 30, 2026 - - Priority Review designation is granted to applications for drugs that, if approved, would be a significant
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"\n- PDUFA target action date of June 30, 2026 -\n\n\n- 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 -\n\n\n- 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 -\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nViridian 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.\n\n\nPriority 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.\n\n\n“We are thrilled that the FDA granted Priority Review for veligrotug, marking another significant milestone for Viridian and the TED community,” said Steve Mahoney, Viridian’s President and CEO. “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 pot...