Viridian Therapeutics Submits BLA for Veligrotug in Thyroid Eye Disease Following Positive Phase 3 Results

Viridian Therapeutics has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug, an investigational monoclonal antibody therapy for thyroid eye disease (TED). The submission, completed in October, is supported by data from two pivotal Phase 3 trials, THRIVE and THRIVE-2, which evaluated veligrotug in both active and chronic TED.

Phase 3 Data Supports Efficacy and Safety of Veligrotug

Veligrotug is a fully human monoclonal antibody targeting IGF-1R (insulin-like growth factor 1 receptor), a validated therapeutic target in TED. Data from the THRIVE and THRIVE-2 studies demonstrated clinically meaningful improvements in proptosis (eye bulging), diplopia (double vision), and other key indicators of disease activity.

The therapy was also generally well tolerated across patient populations in both studies.

Priority Review and Anticipated Commercial Launch

Viridian has included a request for Priority Review in its BLA submission. If granted and the drug is approved, veligrotug could launch commercially as early as mid-2026, offering a new treatment option for patients with TED.

Commenting on the submission, Steve Mahoney, President and CEO of Viridian Therapeutics, stated:

“The submission brings us one step closer to delivering a transformative therapy to people living with TED as well as representing a key inflection point for Viridian as we transition toward a fully integrated commercial organization.”

Expanding Pipeline Beyond Veligrotug

In parallel with veligrotug’s regulatory progress, Viridian is also advancing its TED pipeline with VRDN-003, a subcutaneous candidate currently in Phase 3 clinical trials. Additionally, the company is developing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors targeting a range of autoimmune diseases.