Viridian Therapeutics(VRDN) Seeking Alpha·2024-09-10 21:09Core Insights - Viridian Therapeutics has released positive data from its phase 3 THRIVE study for veligrotug, which treats active thyroid eye disease (TED), achieving a 70% proptosis responder rate compared to 5% for placebo [2][3] - The company plans to file a Biologics License Application (BLA) for veligrotug for both active and chronic TED by the second half of 2025, with additional data from the THRIVE-2 study expected by the end of 2024 [1][8] - Viridian is also developing other candidates, including VRDN-006 for autoimmune disorders and VRDN-008 with extended half-life technology, which may provide competitive advantages in a crowded market [4][8] Company Developments - The THRIVE study involved 154 patients, randomized to receive either 10 mg/kg of veligrotug or placebo over 15 weeks, with a primary endpoint of proptosis responder rate [3] - The primary endpoint was met with statistical significance (p<0.0001), showing a mean reduction in proptosis of 2.9 mm for the drug group versus 0.5 mm for placebo [3] - Viridian's cash position as of June 30, 2024, was 4.13 billion by 2034, indicating significant potential for new treatments [3] - Competition exists with Amgen's Tepezza, which has been on the market since 2020, making it challenging for new entrants like veligrotug to capture market share [3][8] - The anti-FcRn market is becoming crowded, with several players developing similar treatments, necessitating differentiation strategies for Viridian's products [4] Future Catalysts - Results from the THRIVE-2 study are anticipated by the end of 2024, which will be crucial for the company's regulatory strategy [1][8] - Two phase 3 studies for VRDN-003, an anti-IGF-1R monoclonal antibody, were initiated in August 2024, with topline data expected in the first half of 2026 [3][4] - The company aims to initiate a phase 1 study for VRDN-006 by the end of 2024, targeting autoimmune disorders [4]