Viridian Therapeutics submits Biologics License Application to FDA for veligrotug

Viridian Therapeutics has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for veligrotug for the treatment of thyroid eye disease (TED).

Veligrotug is an intravenously delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody. According to the company, it is a “novel, fully human monoclonal antibody [and] 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.”¹

Earlier in the year,² Viridian released positive long-term durability data from THRIVE, its phase 3 clinical trial of veligrotug for TED. At 52 weeks, 70% of patients taking veligrotug (21/30) who were proptosis responders at week 15 and continued follow-up to the end of the study maintained their proptosis response.

As previously³ reported, the THRIVE trial met the primary and all secondary endpoints at 15 weeks after 5 infusions of veligrotug. Additionally, the THRIVE-2 trial⁴ met all primary and secondary end points at the 15-week primary analysis time point after 5 infusions of veligrotug.

Steve Mahoney, Viridian’s president and CEO, commented on the submission in a press release from the company.

“The submission of our BLA for veligrotug marks a major milestone for Viridian. 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,” said Mahoney. “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.”

Viridian’s BLA includes a request for Priority Review, which, if granted, could accelerate the FDA's review timing for a potential mid-2026 veligrotug commercial launch, if approved, according to the company.

Looking forward, the company is currently dosing patients in 2 global phase 3 clinical trials for VRDN-003, REVEAL-1 and REVEAL-2, in active and chronic TED, respectively. The company expects topline data from the trials in the first half of 2026 and plans to submit a BLA for VRDN-003 by the end of 2026.

References:

1. Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease. Published November 3, 2025. Accessed November 3, 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 announces positive long-term durability data for veligrotug for the treatment of active thyroid eye disease. Published May 20, 2025. Accessed November 3, 2025. https://www.ophthalmologytimes.com/view/viridian-therapeutics-announces-positive-long-term-durability-data-for-veligrotug-for-the-treatment-of-active-thyroid-eye-disease

3. Harp MD. Viridian announces positive topline data from phase 3 THRIVE trial evaluating veligrotug in patients with active TED. Ophthalmology Times. September 12, 2024. Accessed May 20, 2025. https://www.ophthalmologytimes.com/view/viridian-announces-positive-topline-data-from-phase-3-thrive-trial-evaluating-veligrotug-in-patients-with-active-ted

4. Harp MD. Viridian announces topline data from THRIVE-2 phase 3 clinical trial of veligrotug for treatment of thyroid eye disease. Ophthalmology Times. December 18, 2024. Accessed May 20, 2025. https://www.ophthalmologytimes.com/view/viridian-announces-topline-data-from-thrive-2-phase-3-clinical-trial-of-veligrotug-for-treatment-of-thyroid-eye-disease

5. Viridian Therapeutics receives FDA breakthrough therapy designation for veligrotug for the treatment of thyroid eye disease (TED). News release. Viridian Therapeutics, Inc. May 7, 2025. Accessed May 20, 2025. https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-Veligrotug-for-the-Treatment-of-Thyroid-Eye-Disease-TED/default.aspx