Business
Viridian Therapeutics Highlights Recent Progress and Reports First Quarter 2025 Financial Results
- Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with potential for U.S. launch in 2026; preparatory commercial
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"\n- Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with potential for U.S. launch in 2026; preparatory commercial activities underway -\n\n- REVEAL-1 and REVEAL-2, phase 3 clinical trials assessing VRDN-003 in active and chronic thyroid eye disease (TED), are on track for topline data in the first half of 2026 -\n\n- VRDN-006 clinical data in healthy volunteers on track for third quarter 2025 -\n\n- VRDN-008, a bispecific neonatal Fc receptor (FcRn) inhibitor with an extended half-life, on track for an Investigational New Drug (IND) submission for year-end 2025 -\n\n- Appointed Jeff Ajer, long-time Chief Commercial Officer of BioMarin, to Viridian’s Board of Directors -\n\n- Strong cash position of $636.6 million as of March 31, 2025, which supports cash runway into the second half of 2027 -\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nViridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the first quarter ended March 31, 2025.\n\n“We continue to execute across the portfolio as we work towards submitting the veligrotug BLA in the second half of 2025, advancing our VRDN-003 subcutaneous clinical trials with anticipated topline data from both trials in the first half of 2026, and delivering healthy volunteer data for our first FcRn program in the third quarter of 2025,” said Steve Mahoney, Viridian’s President and CEO. “As we prepare for our transition to become a commercial organization, including the anticipated U.S. launch of veligrotug in 2026, we are excited to have added Jeff Ajer, an experienced commercial leader, to our Board of Directors. We believe the data from our two pivotal clinical trials support veligrotug having a differentiated clinical profile and believe it will be well-positioned to be the IV treatment-of-choice in TED. From a portfolio perspective, we are in many ways just getting started and we look forward to the potential of bringing new treatment options to TED patients as well as other autoimmune patients who may benefit from our anti-FcRn approaches.”\n\nTED Portfolio Progress\n\nVeligrotug is an intravenously (IV) delivered, anti-insulin-like growth factor-1 recepto...