Viridian Therapeutics Receives FDA Breakthrough Therapy Designation For Veligrotug For Thyroid Eye Disease

Benzinga · 05/07 20:16

- Breakthrough Therapy Designation request based on veligrotug's (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response -

- Veligrotug met all of its primary and secondary endpoints in the pivotal THRIVE and THRIVE-2 clinical trials in active and chronic TED -

- First and only drug candidate in chronic TED to demonstrate statistically significant and clinically meaningful improvement and resolution of diplopia in a global phase 3 clinical trial -

- Breakthrough Therapy Designation supports eligibility for Priority Review -

- Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with a planned U.S. launch in 2026, if approved -