Tegoprubart-treated patients maintained statistically significantly higher kidney function as measured by mean eGFR through 24 months, with an approximately 13 mL/min/1.73 m² advantage versus tacrolimus (71 vs. 58 mL/min/1.73 m²) at month 24

No rejections occurred in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm

Tegoprubart granted U.S. FDA Fast Track designation for the prevention of rejection in kidney transplantation

Phase 3 LEGACY study expected to initiate in the fourth quarter of 2026

IRVINE, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced updated long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented at the International Congress of The Transplantation Society, taking place September 20-23, 2026, in Sydney, Australia. The Company also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to tegoprubart for the prevention of rejection in kidney transplantation.

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address significant unmet medical needs. Companies receiving Fast Track designation may be eligible for more frequent interactions with the FDA, rolling review of future marketing applications, and eligibility for Accelerated Approval and Priority Review

Updated Phase 2 BESTOW Results

  • As of the data cutoff in the BESTOW long-term extension study, 90 patients had been followed through 18 months, and 81 patients had been followed through 24 months. Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR), a measure of kidney graft function, at months 18, 21, and 24, with an approximately 13 mL/min/1.73 m² advantage over tacrolimus at month 24 (71 vs. 58 mL/min/1.73 m² [95% CI: 2.6, 23.3]). See Figure 1.
  • There were no reported cases of biopsy-proven acute rejection (BPAR) in the tegoprubart arm beyond six months post-transplant compared with seven in the tacrolimus arm. One new case of graft loss was observed in the tacrolimus arm.

Next Steps

Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority of tegoprubart versus tacrolimus on a composite efficacy failure endpoint at 12 months, defined as a combination of biopsy-proven acute rejection (BPAR), graft loss, and death.