Business
Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates
- Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), ...
About this update from Viridian Metals Inc
[{"type":"text","content":"Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }\n.bwuline { text-decoration: underline }\n \n\n\n\n\n - Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), REVEAL-1 and REVEAL-2, with each study exceeding its enrollment target due to strong patient demand; topline data on track for first half of 2026 -\n \n\n\n\n - VRDN-003 composition of matter patent granted by the USPTO with term to 2041 and potential to extend exclusivity -\n \n\n\n\n - Veligrotug Biologics License Application (BLA) submission on track and anticipated in November 2025, enabling a mid-2026 commercial launch, if approved under Priority Review -\n \n\n\n\n - VRDN-006 data in ongoing healthy volunteer study shows IgG reductions consistent with the FcRn inhibitor class and sparing of albumin and LDL; half-life extended VRDN-008 IND submission on track for year-end 2025 -\n \n\n\n\n\n Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today announced that enrollment is complete in REVEAL-1 and REVEAL-2, phase 3 clinical trials for VRDN-003 in patients with active and chronic TED, respectively. VRDN-003 is a subcutaneously delivered, half-life extended, monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R).\n \n\n “We are very pleased to continue Viridian’s track record of strong enrollment in TED clinical trials with over 330 TED patients in these two studies, bringing the total number of TED patients participating in Viridian’s clinical trials this year to nearly 500,” said Steve Mahoney, Viridian’s President and Chief Executive Officer. “Both REVEAL-1 and REVEAL-2 are larger than their veligrotug counterparts, and REVEAL-2 is the largest global phase 3 clinical trial conducted in TED to date. Taken together with the majority of patients in each study enrolling from the US, we believe these to be strong signals of patient demand for VRDN-003. With veligrotug marching toward a BLA submission, and Breakthrough Therapy Designation supporting eligi...