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Viridian Therapeutics Submits Biologics License Application for Thyroid Eye Disease Therapy
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Viridian Therapeutics Submits Biologics License Application for Thyroid Eye Disease Therapy
Nov 3, 2025 8:01 AM

10:30 AM EST, 11/03/2025 (MT Newswires) -- Viridian Therapeutics ( VRDN ) submitted a Biologics License Application to the U.S. Food and Drug Administration in October for veligrotug, its investigational therapy for the treatment of thyroid eye disease.

Veligrotug "has demonstrated promising results in pivotal clinical studies, with data showing improvement in proptosis, diplopia, and other key measures of disease activity and was generally well tolerated," Viridian said Monday in a statement.

The submission was supported by data from two pivotal Phase 3 clinical trials that evaluated the efficacy and safety of veligrotug in patients with active and chronic thyroid eye disease, Viridian said.

The application includes a request for a priority review, which may lead to a mid-2026 commercial launch for the drug if approved, the company said.

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