FDA Grants Priority Review to Viridian Therapeutics' Veligrotug for Thyroid Eye Disease

Reuters2025-12-22

FDA Grants Priority Review to Viridian <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' Veligrotug for Thyroid Eye Disease

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Viridian Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251222159703) on December 22, 2025, and is solely responsible for the information contained therein.

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