Eledon Pharmaceuticals Initiates Phase 3 Trial for Tegoprubart in Kidney Transplantation

IRVINE, Calif., Nov. 12, 2026 /CourierPR/ -- Eledon Pharmaceuticals, Inc. ("Eledon"), a clinical stage biotechnology company, has reported significant progress in its ongoing clinical programs and financial health. The company's lead investigational product, tegoprubart, an anti-CD40L antibody, continues to show promise in various transplant settings, including kidney and islet cell transplantation.

In the third quarter of 2026, Eledon initiated a global Phase 3 LEGACY trial of tegoprubart in kidney transplantation, which is expected to enroll approximately 600 patients. The primary endpoint of the trial is non-inferiority of tegoprubart versus tacrolimus at 52 weeks, based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death. This trial is scheduled to commence in the fourth quarter of 2026, marking a pivotal milestone in the company's development pipeline.

Eledon also received FDA clearance for its Investigational New Drug (IND) application for a planned Company-sponsored, registrational path clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The first patients were enrolled in an investigator-initiated clinical trial at the University of Chicago Medicine Transplant Institute, evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease who are receiving an islet cell transplant.

Notably, tegoprubart received Fast Track designation from the FDA for the prevention of rejection in kidney transplantation. The company also reported positive patient-reported outcomes data from the Phase 2 BESTOW clinical program, presented at the American Society of Nephrology (ASN) Kidney Week 2026 Annual Meeting. Results showed that tegoprubart-treated patients demonstrated sustained improvements in quality of life and symptom burden compared to tacrolimus, the standard of care immunosuppression therapy. Specifically, tegoprubart-treated patients experienced a mean improvement on the total Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) at 12 months, while tacrolimus-treated patients experienced a mean worsening of symptom occurrence.

In the islet cell transplantation setting, Eledon reported updated long-term data from the Phase 2 BESTOW extension study, presented at the International Congress of the Transplantation Society (TTS) in September 2026. Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR) at 18, 21, and 24 months, with an approximately 13 mL/min/1.73m2 advantage over tacrolimus at month 24 (71 vs. 58 mL/min/1.73m2 (95% CI: 2.6, 23.3)). There were no reported cases of biopsy-proven acute rejection (BPAR) in the tegoprubart arm beyond six months post-transplant compared with seven BPAR events in the tacrolimus arm.

Financially, Eledon's cash, cash equivalents, and short-term investments stood at $69.7 million as of September 30, 2026, compared to $133.3 million as of December 31, 2025. The company expects its current financial resources to fund operations into the second quarter of 2027. Research and development expenses for the third quarter of 2026 were $17.8 million, including $0.9 million of non-cash stock-based compensation expense, compared to $15.0 million, including $1.1 million of non-cash stock-based compensation expense, for the comparable period in 2025. General and administrative expenses for the third quarter of 2026 were $3.9 million, including $1.0 million of non-cash stock-based compensation expense, compared to $4.1 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2025. Net loss for the third quarter of 2026 was $3.9 million, or $0.03 per basic common share, compared to a net loss of $17.5 million, or $0.21 per basic common share, for the comparable period in 2025. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $21.0 million for the three months ended September 30, 2026, and $18.0 million for the three months ended September 30, 2025.

The company's ongoing efforts in developing tegoprubart for various transplant settings, coupled with the positive financial outlook, underscore its commitment to advancing immunomodulatory therapies for life-threatening conditions.