Eledon Pharmaceuticals, Inc.

Eledon Pharmaceuticals Presents Phase 2 BESTOW Trial Data Showing Sustained Improvements in Quality of Life and Symptom Burden with Tegoprubart Compared to Tacrolimus at American Society of Nephrology Kidney Week 2026 Annual Meeting

Eledon presented new positive patient-reported outcomes from the Phase 2 BESTOW trial at ASN Kidney Week 2026, showing sustained quality-of-life and symptom-burden improvements with tegoprubart versus tacrolimus through 12 months post kidney transplant. Tegoprubart patients improved 9.0 points on the KDQOL-SF Symptoms and Problems Scale versus 3.3 for tacrolimus (p<0.05), with greater symptom improvement in 22 of 23 differential domains; tegoprubart patients improved while tacrolimus patients worsened on the total MTSOSD-59R at Month 12. The data reinforce tegoprubart's differentiated clinical profile versus the standard of care and support its potential to become a transformative kidney-transplant immunosuppression option, though it remains investigational and further trials are needed.

•6d ago

Eledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society

Eledon presented updated 24-month data from the Phase 2 BESTOW extension study showing tegoprubart-treated kidney transplant patients maintained a statistically significant eGFR advantage of roughly 13 mL/min/1.73 m2 over tacrolimus at month 24 (71 vs. 58 mL/min/1.73 m2). No biopsy-proven acute rejections occurred in the tegoprubart arm beyond six months post-transplant, versus seven in the tacrolimus arm; 90 patients were followed through 18 months and 81 through 24 months. The FDA granted tegoprubart Fast Track designation for prevention of rejection in kidney transplantation, and Eledon remains on track to initiate the Phase 3 LEGACY trial, expected to enroll approximately 600 patients, in the fourth quarter of 2026.

•1mo ago

Eledon Pharmaceuticals Announces Islet Cell Transplantation IND Submission, First Patients Enrolled in Multiple Transplant Programs, and Reaffirms Plan to Initiate Phase 3 Kidney Transplantation Trial in Fourth Quarter 2026

Eledon submitted an IND to the FDA for its first company-sponsored registrational study of tegoprubart in islet cell transplantation for type 1 diabetes patients, a key step in building a second registrational pathway for the anti-CD40L antibody. The company reaffirmed it remains on track to initiate the global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026, expected to enroll approximately 600 patients with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks. Early-access programs are broadening: first patients were enrolled or dosed in investigator-initiated and compassionate-use studies at UChicago Medicine, Duke, and Mass General, and the UChicago islet study expanded to 15 patients after all 12 treated to date achieved insulin independence with follow-up out to 22 months.

•1mo ago

Eledon Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Eledon Pharmaceuticals cleared a key regulatory hurdle with a successful FDA End-of-Phase 2 meeting, positioning tegoprubart to initiate a global Phase 3 kidney transplant trial in late 2026. New data from the BESTOW trial showed tegoprubart maintained statistically significant kidney function superiority over tacrolimus at 18 months, while a separate study demonstrated 100% insulin independence in islet cell transplant patients. Financially, the company holds $88.8 million in cash and investments, sufficient to fund operations into the second quarter of 2027, with a Q2 net loss of $31.6 million driven largely by non-cash warrant valuation changes.

•2mo ago

Natera and Eledon Announce Strategic Partnership for Prospera™ Monitoring in Planned Phase 3 Kidney Transplant Trial

Eledon Pharmaceuticals partnered with Natera to exclusively use the Prospera dd-cfDNA test in its planned Phase 3 trial of tegoprubart for kidney transplantation. The trial is expected to enroll approximately 600 patients across over 100 transplant centers globally, with initiation slated for late 2026. Tegoprubart is an investigational anti-CD40L antibody designed to prevent organ rejection while reducing the toxicities associated with current standard-of-care treatments.

•4mo ago

Eledon Presents Long-Term Extension Phase 2 BESTOW Results at American Transplant Congress Showing Sustained Higher Kidney Function and Improved Patient-Reported Outcomes with Tegoprubart Compared with Tacrolimus

Eledon Pharmaceuticals presented long-term data from its Phase 2 BESTOW trial showing tegoprubart-treated patients maintained higher kidney function compared to tacrolimus. At 18 months, the tegoprubart arm demonstrated a statistically significant 12 mL/min/1.73 m² advantage in mean eGFR (74 vs. 61) and reported no biopsy-proven acute rejection events after six months. Following a successful FDA End-of-Phase 2 meeting, the company plans to initiate Phase 3 development of tegoprubart in late 2026.

•4mo ago

Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine

Eledon announced updated results from an investigator-initiated trial of tegoprubart in 12 Type 1 Diabetes patients undergoing islet transplantation at UChicago Medicine. All 12 patients achieved insulin independence and maintained HbA1c levels below 6.5%, with a mean of 5.4%, representing a 2.6% improvement from baseline. The study reported zero severe hypoglycemic episodes and zero rejection events, avoiding the nephrotoxicity and other side effects associated with standard calcineurin inhibitor regimens like tacrolimus. Breakthrough T1D funded the study and has committed to funding a second study evaluating tegoprubart in T1D patients with chronic kidney disease.

•4mo ago

Eledon Announces Presentation of Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at American Diabetes Association (ADA) 2026 Scientific Sessions

Eledon Pharmaceuticals will present updated results from an investigator-initiated islet transplant trial of its lead asset, tegoprubart, at the American Diabetes Association 2026 Scientific Sessions. The oral presentation, titled 'Anti-CD40L to Induce Graft Survival and Function in Islet Allotransplantation,' will be delivered by Dr. Piotr Witkowski of the University of Chicago Medicine Transplant Institute on June 7, 2026. Tegoprubart is an anti-CD40L antibody being developed for immune modulation in transplantation and other life-threatening conditions, with this data supporting its potential in Type 1 Diabetes management.

•4mo ago