FDA Grants Priority Review to Viridian Therapeutics' Veligrotug for Thyroid Eye Disease
Viridian Therapeutics, Inc. VRDN | 0.00 |
Viridian Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug, a treatment for thyroid eye disease (TED), and granted it Priority Review. This designation shortens the review period to six months and recognizes veligrotug as a potential significant improvement in the safety or effectiveness of TED treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. The BLA is supported by positive results from two large phase 3 clinical trials. Preparations are underway for the anticipated commercial launch, and Viridian plans to submit a similar application to the European Medicines Agency in early 2026.
