WALTHAM, Mass.– Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today announced the completion of enrollment in its two phase 3 clinical trials for VRDN-003 in thyroid eye disease (TED). The trials, known as REVEAL-1 and REVEAL-2, both exceeded their enrollment targets due to strong patient demand. Topline data remain on track for the first half of 2026.
VRDN-003 is a subcutaneously delivered, half-life extended monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R). In REVEAL-1, which studies patients with active TED, 132 participants were enrolled compared to a target of 117. REVEAL-2, which focuses on patients with chronic TED, enrolled 204 participants versus a target of 195. The company noted that 67 percent of patients in REVEAL-1 and 56 percent in REVEAL-2 were enrolled in the United States.
“We are very pleased to continue Viridian’s track record of strong enrollment in TED clinical trials with over 330 TED patients in these two studies, bringing the total number of TED patients participating in Viridian’s clinical trials this year to nearly 500,” said Steve Mahoney, Viridian’s President and Chief Executive Officer. “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. 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. With veligrotug marching toward a BLA submission, and Breakthrough Therapy Designation supporting eligibility for Priority Review, we believe veligrotug and VRDN-003 have the potential to establish a new standard of care for patients. We would like to thank all the patients, caregivers, and clinical trial sites who are participating in our clinical studies.”
Viridian plans to submit a Biologics License Application (BLA) for VRDN-003 by year-end 2026 and, if approved, launch with a low-volume autoinjector designed to allow patients to self-administer at home. The U.S. Patent and Trademark Office has also granted a composition of matter patent for VRDN-003 with a term to 2041 and the potential for extended exclusivity.
Separately, Viridian said it remains on track to submit a BLA for veligrotug in November 2025. The therapy received Breakthrough Therapy Designation in May 2025, supporting eligibility for Priority Review. If approved, veligrotug could be commercially launched in mid-2026. A new patent for veligrotug’s method of use, with a term to 2042, was also granted.
In its neonatal Fc receptor (FcRn) inhibitor portfolio, Viridian reported that VRDN-006 has achieved proof-of-concept in its ongoing phase 1 study in healthy volunteers. The therapy showed IgG reductions consistent with the FcRn inhibitor class while sparing albumin and LDL. To date, VRDN-006 has been generally well tolerated with no dose-limiting toxicities or serious adverse events observed.
The company also said that an Investigational New Drug (IND) submission for VRDN-008 remains on track for year-end 2025. VRDN-008 demonstrated an extended half-life and more sustained IgG reduction compared with efgartigimod after a single high dose in non-human primates.
