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VRDN Stock Soars as Eye Disorder Study Meets Primary Endpoints
VRDNViridian Therapeutics(VRDN) ZACKS·2024-09-11 16:30

Core Viewpoint - Viridian Therapeutics, Inc. announced positive results from the phase III THRIVE study for its lead drug veligrotug, leading to a 32.1% surge in share price on September 10 [1]. Study Results - The THRIVE study met all primary and secondary endpoints, showing statistically significant improvements in thyroid eye disease (TED) symptoms after 15 weeks of treatment with veligrotug [2]. - Patients receiving veligrotug had a 70% proptosis responder rate compared to 5% for the placebo group, with a mean reduction in proptosis of 2.9 mm versus 0.5 mm [3]. - Complete resolution of diplopia was observed in 54% of patients treated with veligrotug, compared to 12% in the placebo group [4]. - An overall response rate of 67% was achieved in the veligrotug group versus 5% in the placebo group, indicating the treatment was generally safe and well tolerated [5]. Future Plans - Viridian plans to file a biologics license application (BLA) for veligrotug in the second half of 2025 and is also evaluating another candidate, VRDN-003, in late-stage studies for TED [6][7]. - Top-line data from the phase III studies for VRDN-003 is expected in the first half of 2026, with a BLA filing anticipated by the end of 2026 [8]. Competitive Landscape - If approved, veligrotug and VRDN-003 will face competition from Amgen's Tepezza, the first approved drug for TED, which is administered intravenously [9]. - Amgen is also developing a subcutaneous formulation of Tepezza, which may offer a more convenient administration method compared to intravenous drugs [9][10].