Viridian Therapeutics receives FDA breakthrough designation for Veligrotug

Viridian Therapeutics (VRDN) announced that the United States Food and Drug Administration granted Breakthrough Therapy Designation to veligrotug, the company’s lead anti-insulin-like growth factor-1 receptor drug candidate for the treatment of TED. Breakthrough Therapy Designation is reserved for drug candidates intended to treat serious or life-threatening conditions that address an unmet need where clinical evidence has indicated they may demonstrate substantial improvement on a clinically significant endpoint over existing therapies. “The FDA’s decision to grant veli Breakthrough Therapy Designation underscores that veli may offer substantial improvement over existing therapies, and we believe it reinforces veli’s potential to be a differentiated, treatment-of-choice for patients living with TED,” said Steve Mahoney, Viridian’s President and CEO. “Veli is the only therapy that has demonstrated statistically significant and clinically meaningful improvement and resolution of diplopia in both active and chronic TED. Veli also showed a rapid onset of treatment effect, including an improvement in proptosis response in as few as three weeks after just one infusion. We believe veli will be an important potential new treatment option for patients living with TED, including whose disease is unaddressed by existing therapies. We continue to execute on our planned BLA submission in the second half of 2025 and are excited that this designation supports eligibility for Priority Review as we prepare for our planned U.S. commercial launch in 2026.”