Viridian Therapeutics Announces Submission of BLA for Veligrotug in Thyroid Eye Disease

Viridian Therapeutics has submitted its Biologics License Application (BLA) for veligrotug, an investigative therapy for the treatment of thyroid eye disease (TED), to the US Food and Drug Administration (FDA).1

Announced on November 3, 2025, the submission is supported by data from 2 pivotal phase 3 clinical trials: THRIVE and THRIVE-2. The submission also includes a request for priority review, which could accelerate the review timing for veligrotug. If approved, Viridian has stated a goal of commercial launch in mid-2026.1

“This submission brings us one step closer to delivering a transformative therapy to people living with thyroid eye disease, as well as representing a key inflection point for Viridian as we transition toward a fully integrated commercial organization,” Steve Mahoney, president and chief executive officer of Viridian Therapeutics, said in a statement. “We are grateful to the patients, investigators, our clinical partners, the FDA, and the entire Viridian team whose commitment has made this achievement possible.”1

Veligrotug is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, currently in phase 3 development for TED. It has demonstrated robust clinical activity in the THRIVE and THRIVE-2 trials, both of which achieved all primary and secondary endpoints. Additionally, it was well-tolerated during both trials.1

The THRIVE trial involved patients with TED, evaluating 5 infusions of veligrotug versus placebo every 3 weeks. Primary topline analysis was conducted at 15 weeks, and patients were followed through week 52. A total of 30 patients were assigned to veligrotug; of these, 70% (n = 21) were proptosis responders at week 15 and maintained their response to week 52. This maintenance was defined as responders at week 15 with ≥2 mm reductions in proptosis compared to baseline at week 52, without worsening in the fellow eye.2

The THRIVE-2 study also displayed positive topline results, meeting all primary and secondary endpoints at the 15-week primary analysis timepoint after 5 infusions of veligrotug. Patients showed statistically significant responses on all of the measured signs and symptoms of TED, including proptosis and diplopia.3

THRIVE-2 included 188 patients, with 125 randomly assigned to veligrotug and 63 assigned to placebo. At week 15, 56% of patients in the veligrotug arm, compared to 8% in the placebo arm, exhibited proptosis response. Response rate was significant as early as 3 weeks after first infusion, demonstrating a rapid response onset. Diplopia response was achieved by 56% of veligrotug recipients versus 25% of placebo patients, with onset observed at 6 weeks after 2 infusions.3

These 2 pivotal trials ultimately highlighted veligrotug’s rapid and statistically significant effects on multiple symptoms of TED, such as the first demonstration of diplopia response and resolution in a global chronic TED phase 3 study.1

“The submission of our BLA for veligrotug marks a major milestone for Viridian,” Mahoney said in a statement. “Our team was able to submit the application despite the ongoing government shutdown following productive engagements with the FDA, reflecting our continued positive interactions with the agency to date.”1

References

1. Viridian Therapeutics. Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to US FDA for Veligrotug in Thyroid Eye Disease. November 3, 2025. Accessed November 4, 2025. https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Announces-Successful-October-Submission-of-Biologics-License-Application-BLA-to-U-S--FDA-for-Veligrotug-in-Thyroid-Eye-Disease/default.aspx

2. Viridian Therapeutics. Viridian Therapeutics Announces Positive Long-Term Durability Data from the Veligrotug Phase 3 THRIVE Clinical Trial in Patients with Active Thyroid Eye Disease (TED). May 20, 2025. Accessed November 4, 2025. https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Announces-Positive-Long-Term-Durability-Data-from-the-Veligrotug-Phase-3-THRIVE-Clinical-Trial-in-Patients-with-Active-Thyroid-Eye-Disease-TED/default.aspx

3. Viridian Therapeutics. Viridian Therapeutics Announces Positive Topline Results from Veligrotug Phase 3 THRIVE-2 Clinical Trial in Patients with Chronic Thyroid Eye Disease. December 16, 2024. Accessed November 4, 2025. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-Phase-3-THRIVE-2-Clinical-Trial-in-Patients-with-Chronic-Thyroid-Eye-Disease/default.aspx