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What will be the primary outcome of the BLA submission for VRDN-001?
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Viridian Therapeutics•Veligrotug•Clinical Activity Score•Viridian•Biologics License Application•Amgen
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FDA approval announcements or Viridian Therapeutics' official announcements
Story
Viridian Therapeutics Announces Positive Results from Phase 3 THRIVE Trial for TED with VRDN-001 Veligrotug
Sep 10, 2024, 11:06 AM
Viridian Therapeutics announced positive topline results from its Phase 3 THRIVE clinical trial of Veligrotug (VRDN-001), an experimental treatment for thyroid eye disease (TED). The results showed significant improvement in reducing eye bulging and achieving primary goals. Key findings include a 70% proptosis responder rate, 54% complete resolution of diplopia, and 64% reduction of Clinical Activity Score to 0 or 1. The treatment was well-tolerated with no treatment-related serious adverse events. Viridian plans to submit a Biologics License Application (BLA) in 2025. The results compared favorably to a similar drug already approved and sold by Amgen. A webcast to discuss the results is scheduled for September 10, 2024, at 8:00am ET.
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