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Viridian Therapeutics Prepares for Transformational 2026
Businesswire· 2026-01-06 12:01
Core Insights - Viridian Therapeutics is focused on creating best-in-class medicines for serious and rare diseases, with key priorities set for 2026, including pivotal data delivery and potential product launches [2][5][8]. Group 1: Product Development and Pipeline - The FDA has accepted the Biologics License Application (BLA) for veligrotug under Priority Review, with a target action date of June 30, 2026, indicating a significant need for new treatment options in Thyroid Eye Disease (TED) [5][8]. - Veligrotug has shown positive results in two large Phase 3 trials (THRIVE and THRIVE-2), demonstrating rapid treatment effects and durable responses in patients with active and chronic TED [5][8]. - The company is on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency in Q1 2026 [5]. - Topline data for elegrobart (VRDN-003) is expected in Q1 and Q2 2026 from ongoing Phase 3 trials (REVEAL-1 and REVEAL-2) [5][8]. - A new TSHR inhibitor program is being developed, with an Investigational New Drug (IND) application expected in Q4 2026 [5][9]. Group 2: Market Strategy and Commercialization - The U.S. TED market is valued at approximately $2 billion, with the company targeting around 2,000 core prescribers for its products [5][8]. - The commercial infrastructure for the veligrotug launch is anticipated to facilitate the launch of elegrobart, which is expected to be the only autoinjector for TED at the time of its launch [5][8][13]. - The company ended October 2025 with approximately $888 million in cash and investments, positioning it well to fund its business plans through profitability [12]. Group 3: Clinical Trials and Research - VRDN-006 has achieved proof-of-concept for IgG reduction in healthy volunteers, demonstrating its potential within the FcRn inhibitor class [5][9]. - VRDN-008's IND was submitted in December 2025, with Phase 1 healthy volunteer data expected in the second half of 2026 [12].