ELDN News & Events

Eledon Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug designation, ODD, to tegoprubart for the prevention of allograft rejection in liver transplantation. "Clinical studies in kidney transplantation have demonstrated that tegoprubart has the potential to improve graft survival and function while reducing the side effects associated with calcineurin inhibitors, supporting its promise as a novel immunosuppressive therapy across multiple organ transplant settings," said David-Alexandre C. Gros, MD, Chief Executive Officer of Eledon. "Based on the encouraging preclinical evidence we have generated to date, we believe liver transplantation represents a significant incremental opportunity for tegoprubart, and we look forward to evaluating its potential in the clinical setting through an anticipated investigator sponsored trial initiating later this year."

NewcelX (NCEL) announced a collaborative research agreement with Eledon Pharmaceuticals (ELDN). The collaboration is designed to advance combination strategies integrating NewcelX's lead program, NCEL-101, with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart, with the goal of supporting durable, immune-protected islet replacement and advancing a potential functional cure for Type 1 Diabetes.

Eledon Pharmaceuticals announced that it will present 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium, taking place January 23-25, 2026, in Scottsdale, Arizona. There were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate increased over the measurement period.

Eledon Pharmaceuticals announced preliminary results from an investigator-initiated trial conducted at the University of Chicago Medicine's Transplant Institute and presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, held November 14-17, 2025 at City of Hope in Los Angeles, California. The ongoing trial, which has been extended to include a total of 12 subjects, is evaluating tegoprubart, Eledon's investigational anti-CD40 Ligand antibody, as the core of a tacrolimus-free immunosuppression drug regimen for the prevention of islet transplant rejection in individuals with type 1 diabetes. The results provide updated preliminary data on the first six subjects in the trial, demonstrating the ability of tegoprubart to prevent the rejection of transplanted islet cells in the absence of calcineurin inhibition resulting in sustained insulin-free management of hemoglobin A1C in patients with T1D. All six transplanted subjects demonstrated marked improvements in glycemic control, achieving and maintaining insulin independence after one or two islet transplants, primarily depending on the subjects' body mass and baseline daily insulin requirements. The first three participants were transplanted over a year ago and have remained insulin-free, including a patient who has maintained stable blood glucose control reflected by an HbA1c as low as 4.7%, for over 15 months without the use of exogenous insulin. Two subsequent subjects transplanted in July achieved insulin independence within approximately four weeks following a single islet transplantation and have maintained an HbA1c below 6% for over three months. A sixth subject, who was transplanted in early August, recently underwent a second islet infusion and is now insulin free with an HbA1c of 5.3%. All six patients have been free of severe hypoglycemic episodes since their transplants. Tegoprubart was generally well tolerated, with no reported serious infections, no thromboembolic or rejection events, and no signs of the kidney or neurological toxicity often observed with traditional calcineurin inhibitor-based immunosuppression.