FDA Accepts Viridian Therapeutics' Veligrotug BLA for Priority Review

Reuters01-06

FDA Accepts Viridian <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' Veligrotug BLA for Priority Review

Viridian Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for veligrotug under Priority Review for the treatment of thyroid eye disease (TED). The Prescription Drug User Fee Act (PDUFA) target date for a decision is set for June 30, 2026. The company is preparing for a potential U.S. launch of veligrotug in mid-2026 and plans to submit a Marketing Authorization Application $(MAA)$ to the European Medicines Agency in the first quarter of 2026. No other beneficiary organizations were mentioned.

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: 20260106202623) on January 06, 2026, and is solely responsible for the information contained therein.

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