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Eledon Pharmaceuticals develops immune-modulating therapies as a clinical-stage biotechnology company focused on transplant medicine and other life-threatening conditions. Its lead investigational product, tegoprubart, is an anti-CD40L antibody designed to target the CD40 Ligand pathway, with programs and study updates tied to kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis.
Company news commonly covers tegoprubart clinical data, investigator-initiated transplant studies, FDA orphan drug designations, research collaborations, conference presentations and operating results. Updates also address how the company positions CD40L modulation as a non-lymphocyte-depleting immunomodulatory approach for preventing organ rejection and supporting transplanted cell or organ grafts.
Eledon Pharmaceuticals (ELDN) reported updated long-term Phase 2 BESTOW extension data for tegoprubart in kidney transplantation and Fast Track designation from the U.S. FDA for preventing kidney transplant rejection.
In the extension study, tegoprubart-treated patients showed statistically significantly higher mean eGFR 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). No biopsy-proven acute rejections occurred in the tegoprubart arm beyond six months post-transplant, versus seven in the tacrolimus arm, and one new graft loss was reported in the tacrolimus arm. As of the cutoff, 90 patients were followed through 18 months and 81 through 24 months.
Eledon plans to initiate the global Phase 3 LEGACY trial in the fourth quarter of 2026, targeting about 600 patients and a 12‑month composite efficacy failure primary endpoint.
Eledon Pharmaceuticals (ELDN)/b) will deliver an oral presentation on the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection at the International Congress of The Transplantation Society in Sydney, Australia, held from September 20–23, 2026.The Phase 2 BESTOW trial and its extension will be presented by Andrew Adams, M.D., Ph.D., in the “Novel immunosuppression” session on Tuesday, September 22, 2026, from 8:00AM to 9:00AM AEST.
Eledon Pharmaceuticals (ELDN) reported multiple milestones for its investigational anti-CD40L antibody tegoprubart across kidney and islet cell transplantation programs.
The company submitted an IND to the FDA for a planned Eledon-sponsored, registrational trial of tegoprubart to prevent allograft rejection in type 1 diabetes patients undergoing pancreatic islet cell transplantation, its first company-sponsored islet trial. The first patients have been enrolled in a new investigator-initiated study at the University of Chicago Medicine evaluating a calcineurin inhibitor–free, tegoprubart-based regimen in islet recipients with renal dysfunction, and the first islet transplant recipient has been converted from tacrolimus to tegoprubart under compassionate use due to calcineurin inhibitor–related renal dysfunction.
An ongoing UChicago investigator-initiated study in T1D islet recipients is being expanded by three patients beyond 12 already treated, all of whom achieved insulin independence with HbA1c below 7.0% and stable islet graft function through up to 22 months, with no observed nephrotoxicity, hypertension, or neurotoxicity. Eledon also reaffirmed plans to start the global Phase 3 LEGACY kidney transplant trial in Q4 2026, targeting about 600 patients with a 52-week non-inferiority endpoint versus tacrolimus, and reported first compassionate-use dosing in a highly sensitized kidney recipient and a third patient treated in a kidney transplant tolerance study at Massachusetts General Hospital.
Eledon Pharmaceuticals (Nasdaq: ELDN) reported second quarter 2026 results and clinical progress for its lead anti-CD40L antibody, tegoprubart. A successful End-of-Phase 2 FDA meeting supports a global Phase 3 kidney transplantation trial planned for late 2026, targeting about 600 patients with a composite non-inferiority primary endpoint versus tacrolimus at 52 weeks.
Long-term Phase 2 BESTOW data showed mean eGFR about 12 mL/min/1.73 m² higher with tegoprubart at 18 months, no biopsy-proven acute rejection after six months, and better symptom scores versus tacrolimus. In an islet cell transplant study, all 12 type 1 diabetes patients achieved insulin independence. Cash, cash equivalents and short-term investments were $88.8 million at June 30, 2026, expected to fund operations into Q2 2027; Q2 net loss was $31.6 million, or $0.27 per share.
Natera (Nasdaq:NTRA) and Eledon (Nasdaq:ELDN) formed a strategic partnership to use Natera’s Prospera kidney transplant assessment test in Eledon’s planned Phase 3 trial of tegoprubart.
Prospera will be the exclusive donor-derived cell-free DNA monitoring assay in a ~600-patient kidney transplant study expected to start in late 2026.
Eledon (Nasdaq:ELDN) reported long-term Phase 2 BESTOW extension data in kidney transplant patients treated with tegoprubart versus tacrolimus. Tegoprubart showed higher mean eGFR, no biopsy-proven acute rejection after six months, fewer key CNS/kidney adverse events, and better patient-reported symptom scores, supporting planned Phase 3 initiation in late 2026.
Eledon (NASDAQ: ELDN) reported updated data from a 12-patient, investigator-initiated islet transplant trial of tegoprubart in type 1 diabetes at UChicago Medicine.
According to Eledon, 100% of patients achieved insulin independence, mean HbA1c fell from ~8.0% to ~5.4%, and no severe post-transplant hypoglycemia or rejection episodes were observed over up to 22 months.
Eledon (Nasdaq: ELDN) announced that updated data from an investigator-initiated islet transplant trial of tegoprubart in patients with type 1 diabetes will be presented at the American Diabetes Association 86th Scientific Sessions on June 7, 2026, in New Orleans.
The oral presentation, titled “Anti-CD40L to Induce Graft Survival and Function in Islet Allotransplantation”, will be delivered by Piotr Witkowski, M.D., Ph.D. in Session “Immune Modulatory Strategies for Next-Generation Cell Therapies,” from 2:30 p.m. to 3:00 p.m. CT in Room 343 (Level 3).
Eledon Pharmaceuticals (Nasdaq: ELDN) will present new clinical data on tegoprubart in kidney transplantation at the American Transplant Congress in Boston from June 20-24, 2026.
Presentations include updated Phase 2 BESTOW results, long-term extension data, and a June 22, 2026 investor conference call.
Eledon Pharmaceuticals (Nasdaq: ELDN) reported Q1 2026 results and key updates on tegoprubart.
All 10 evaluable type 1 diabetes patients achieved 100% insulin independence after islet transplantation. Tegoprubart received FDA Orphan Drug designation in liver transplantation. Cash was $111.1M, funding operations into 2Q 2027; Q1 net loss was $39.0M.