Eledon Pharmaceuticals reported third-quarter 2026 financial results Thursday and confirmed its global Phase 3 LEGACY kidney transplant trial of tegoprubart remains on track to launch in the fourth quarter. The pivotal study will enroll approximately 600 patients evaluating tegoprubart against standard-of-care tacrolimus. According to Eledon’s official release and Clinical Trial Vanguard on Friday, the 52-week LEGACY trial will assess non-inferiority on a composite endpoint of biopsy-proven acute rejection, graft loss, and death.
In the Phase 2 BESTOW extension study, zero biopsy-proven acute rejections occurred in the tegoprubart arm beyond six months post-transplant, compared with seven events on tacrolimus. Eledon CEO David-Alexandre C. Gros said the company was focused on key strategic priorities and the tegoprubart clinical program across multiple transplant types, including plans to initiate the global Phase 3 LEGACY trial in kidney transplantation by year end. Tegoprubart holds FDA Fast Track designation for preventing kidney transplant rejection. By selectively blocking the CD40 ligand pathway, tegoprubart aims to prevent organ rejection without damaging transplanted kidneys or triggering metabolic side effects.
Eledon confirmed the FDA cleared its Investigational New Drug application for a registrational-path islet cell transplant trial in type 1 diabetes. At the University of Chicago Medicine Transplant Institute, 12 treated patients achieved 100 percent insulin independence with stable graft function through 22 months of follow-up. Investigators observed none of the nephrotoxicity, hypertension, or neurotoxicity commonly associated with tacrolimus-based maintenance regimens. Three additional patients recently enrolled at the Chicago center to expand the dataset.
Eledon ended September 30 with $69.7 million in cash, cash equivalents, and short-term investments, down from $133.3 million at year-end 2025. Management reiterated that existing liquidity funds operations into the second quarter of 2027.
