Viridian files BLA for veligrotug in thyroid eye disease

US biopharma firm Viridian Therapeutics (Nasdaq: VRDN) today announced the successful submission of its biologics license application (BLA) to the US Food and Drug Administration (FDA) for veligrotug, the company’s investigational therapy for the treatment of thyroid eye disease (TED).

Veligrotug, a novel, fully human monoclonal antibody, 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. Based on these results, veligrotug was granted Breakthrough Therapy designation for the treatment of TED earlier this year. Viridian’s BLA includes a request for Priority Review, which if granted, could accelerate FDA's review timing for a potential mid-2026 veligrotug commercial launch, if approved.

Last month, Viridian entered into a royalty financing agreement with DRI Healthcare Acquisitions (DRI), under which it will receive up to $300 million, subject to the terms and conditions of the agreement, including: $55 million upfront payment upon execution of the agreement; $115 million in potential near-term milestones linked to the achievement of positive top-line data in REVEAL-1 and REVEAL-2, Phase III pivotal studies for VRDN-003, and US veligrotug marketing approval.