Tegoprubart (AT-1501) - (BESTOW)

September 22, 2026: Eledon Pharmaceuticals (NASDAQ: ELDN) reported updated long-term Phase 2 BESTOW/BESTOW EXTENSION data for tegoprubart in kidney transplantation at the International Congress of The Transplantation Society and said the FDA granted Fast Track designation for prevention of rejection in kidney transplantation.

At the August 31, 2026 data cutoff, 90 patients had reached 18 months and 81 had reached 24 months. Tegoprubart maintained statistically significantly higher mean eGFR than tacrolimus at months 18, 21, and 24, including about a 13 mL/min/1.73 m² advantage at month 24 (71 vs. 58 mL/min/1.73 m²; 95% CI: 2.6, 23.3). No biopsy-proven acute rejection cases were reported in the tegoprubart arm beyond six months post-transplant, versus seven in the tacrolimus arm; one new graft loss occurred in the tacrolimus arm.

Following an End-of-Phase 2 FDA meeting, the company said it remains on track to start the global Phase 3 LEGACY trial in Q4 2026. LEGACY is expected to enroll about 600 patients and test non-inferiority versus tacrolimus at 12 months on a composite endpoint of biopsy-proven acute rejection, graft loss, and death.