FDA Accepts Viridian's Veligrotug BLA For Priority Review In Thyroid Eye Disease

rttnews
2025.12.23 06:58
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Viridian Therapeutics Inc. announced that the FDA has accepted its Biologics License Application for Veligrotug, a treatment for thyroid eye disease, for priority review. The decision is expected by June 30, 2026. The application is supported by positive Phase 3 trial data, and Veligrotug has been granted breakthrough therapy designation. Viridian plans to submit a Marketing Authorisation Application to the European Medicines Agency in early 2026.