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Viridian Therapeutics Highlights 2025 Corporate Priorities Following Positive Phase 3 Topline Data in Thyroid Eye Disease
- Veligrotug, with recent positive phase 3 topline data in both active and chronic thyroid eye disease (TED), has the potential to transform the standard of
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"\n- Veligrotug, with recent positive phase 3 topline data in both active and chronic thyroid eye disease (TED), has the potential to transform the standard of care in TED with a differentiated clinical profile achieved with less drug and fewer infusions; Biologics License Application (BLA) submission on track for second half of 2025 -\n\n\n- REVEAL-1 and REVEAL-2, phase 3 clinical trials for subcutaneous (SC) VRDN-003 in active and chronic TED respectively, are currently dosing patients; topline data for both trials, which are evaluating VRDN-003 dosed Q4W or Q8W, is on track for the first half of 2026 -\n\n\n- Investigational New Drug (IND) submitted in December 2024 for VRDN-006, an Fc fragment inhibitor of the neonatal Fc receptor (FcRn); proof-of-concept IgG reduction clinical data in healthy volunteers anticipated in the third quarter of 2025 -\n\n\n- VRDN-008, a bispecific FcRn inhibitor with an extended half-life, progressing with preclinical studies as planned; additional preclinical data expected in 2025 with an IND submission planned for year-end 2025 -\n\n\n- Strong cash position of $753 million as of September 30, 2024; provides cash runway into the second half of 2027 through the anticipated commercial launch of veligrotug, topline results and BLA submission for VRDN-003, and multiple FcRn inhibitor portfolio clinical catalysts -\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nViridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announces the company’s key priorities and catalysts for 2025.\n\n\n“After a great year of execution across the portfolio, we enter 2025 poised to deliver on a number of important catalysts,” said Steve Mahoney, Viridian’s President and CEO. “We believe that the positive and better-than-expected topline data for veligrotug in both THRIVE and THRIVE-2 confirms its potential to be the treatment-of-choice for all forms of active and chronic TED at its anticipated commercial launch. Our BLA and early commercial preparations are well underway, and we are on track to submit the BLA in the second half of this year. The results of THRIVE and THRIVE-2 give us even higher conviction that our subcutaneous VRDN-003 program will deliver positive topline data in the first half of 2026, whic...