ELEDON (ELDN) Reports 24-Month Phase 2 Kidney Data and Wins FDA Fast Track
Tegoprubart kept kidney function about 13 mL/min/1.73 m² above tacrolimus at month 24, as Eledon prepares to start its Phase 3 LEGACY trial in Q4.
Eledon Pharmaceuticals (ELDN) presented updated long-term results from the extension of its Phase 2 BESTOW study of tegoprubart in kidney transplant patients at the International Congress of The Transplantation Society in Sydney, and said the U.S. Food and Drug Administration has granted the antibody Fast Track designation for the prevention of rejection in kidney transplantation. Patients on tegoprubart held a statistically significant advantage in kidney graft function over the standard-of-care drug tacrolimus through 24 months. The company reiterated that its global Phase 3 LEGACY trial is on track to begin in the fourth quarter of 2026.