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Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease
- BLA for veligrotug successfully submitted to the U.S. Food and Drug Administration (FDA) in lat...
About this update from Viridian Metals Inc
[{"type":"text","content":"Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwuline { text-decoration: underline }\n \n\n\n\n\n - BLA for veligrotug successfully submitted to the U.S. Food and Drug Administration (FDA) in late October following recent consultation with the agency -\n \n\n\n\n - Veligrotug’s Breakthrough Therapy Designation supports eligibility for potential Priority Review -\n \n\n\n\n - FDA decision whether to accept the BLA for filing is expected within 60 days of submission -\n \n\n\n\n\n Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today announced the successful October submission of its BLA to the U.S. Food and Drug Administration (FDA) for veligrotug, the company’s investigational therapy for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disorder characterized by inflammation and swelling of the tissues around the eyes, often leading to pain, vision impairment, and a significant reduction in quality of life. 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.\n \n\n “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 Steve Mahoney, Viridian’s President and CEO. “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. We are grateful to the patients, investigators, our clinical partners, the FDA, and the ...