Viridian Therapeutics Completes Enrollment in REVEAL-1 and REVEAL-2 Phase 3 Trials for VRDN-003 in TED

Viridian Therapeutics has announced the completion of patient enrollment in its two global Phase 3 clinical trials, REVEAL-1 and REVEAL-2, evaluating VRDN-003 for the treatment of active and chronic thyroid eye disease (TED).

About VRDN-003

VRDN-003 is a subcutaneously administered, half-life extended anti-IGF-1R antibody candidate. It shares the same binding domain as veligrotug but has been engineered for an extended half-life. Viridian is positioning VRDN-003 as a potential best-in-class therapy for TED.

Enrollment Completed for REVEAL-1 and REVEAL-2 Trials

Both REVEAL trials exceeded their target enrollment numbers:

       • REVEAL-1 enrolled 132 patients, surpassing the expected 117

       • REVEAL-2 enrolled 204 patients, exceeding the planned 195

The company also reported that 67% of REVEAL-1 participants and 56% of REVEAL-2 participants were enrolled in the United States.

“Both REVEAL-1 and REVEAL-2 are larger than their veligrotug counterparts, and REVEAL-2 is the largest global phase 3 clinical trial conducted in TED to date,” said Steve Mahoney, President and CEO of Viridian Therapeutics.

“Taken together with the majority of patients in each study enrolling from the US, we believe these to be strong signals of patient demand for VRDN-003.”

Trial Timeline and Upcoming Milestones

Viridian expects topline data from both Phase 3 trials to be available in the first half of 2026. Based on these results, the company plans to submit a Biologics License Application (BLA) for VRDN-003 by year-end 2026.

If approved, the treatment would be offered through a commercially validated, low-volume autoinjector, enabling at-home self-administration for patients.

Veligrotug Update: BLA Submission Planned for November 2025

In addition to the VRDN-003 update, Viridian also shared plans for veligrotug, noting that it aims to submit a BLA in November 2025. Pending Priority Review, available under its Breakthrough Therapy Designation granted in May 2025, the company anticipates a potential commercial launch in mid-2026.