Eledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society
Long-term Phase 2 kidney transplant data and FDA Fast Track status position tegoprubart to advance into a planned 600-patient Phase 3 trial.
Rhea-AI Summary
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.
Positive
- eGFR advantage vs. tacrolimus: ~13 mL/min/1.73 m² at month 24 (71 vs. 58; 95% CI: 2.6, 23.3)
- No BPAR beyond 6 months in tegoprubart arm vs. seven cases in tacrolimus arm
- Patients with long-term follow-up: 90 to 18 months, 81 to 24 months in BESTOW extension
- FDA Fast Track designation for tegoprubart in prevention of kidney transplant rejection
- Planned Phase 3 LEGACY trial to enroll ~600 kidney transplant patients starting Q4 2026
Negative
- None.
News Explained
The FDA granted tegoprubart Fast Track designation for kidney-transplant rejection; under the company’s description, this can allow more frequent FDA interactions and rolling review of a future application, while eligibility for accelerated approval or priority review remains possible rather than guaranteed.
Key Figures
- 24-month eGFR advantage
- Approximately 13 mL/min/1.73 m² advantage (71 vs. 58 mL/min/1.73 m²)
- Tegoprubart versus tacrolimus at month 24
- Post-six-month rejection
- 0 vs. 7 cases
- Tegoprubart versus tacrolimus beyond six months post-transplant
- Patients followed through 18 months
- 90 patients
- BESTOW long-term extension
- Patients followed through 24 months
- 81 patients
- BESTOW long-term extension
- Statistical significance
- p < 0.05
- Treatment difference at months 18, 21, and 24
- Fast Track designation
- Granted
- U.S. FDA designation for prevention of kidney-transplant rejection
- Phase 3 initiation
- Fourth quarter of 2026
- Expected start of the LEGACY kidney-transplant study
- Planned enrollment
- Approximately 600 patients
- Phase 3 LEGACY trial
Previous Clinical trial Reports
-
BESTOW extension showed higher kidney function and no rejection after six months
-
BESTOW results showed non-inferiority and lower selected adverse-event rates
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Key Terms
biopsy-proven acute rejection medical
fast track designation regulatory
non-inferiority technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 BESTOW extension study data and continued improvements in kidney function and safety profile with tegoprubart versus standard of care tacrolimus further strengthen our belief in tegoprubart’s potential to become the new cornerstone immunosuppression therapy for kidney transplant recipients,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “These long-term results, together with FDA Fast Track designation, support our plans to initiate the Phase 3 LEGACY study in kidney transplantation in the fourth quarter and advance tegoprubart as quickly as possible for transplant patients in need of better immunosuppressive options to improve long-term outcomes.”
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.
Figure 1: Patients who completed treatment were those who completed 52 weeks of the study and received all planned doses of the randomized study drug. Data for M15 onward were collected from patients who completed treatment and enrolled in BESTOW EXTENSION. *p < 0.05 (treatment difference at M18, M21 and M24). Data extraction date: 31 Aug 2026. CI, confidence interval; eGFR, estimated glomerular filtration rate; M, Month; SEM, standard error of the mean; tac, tacrolimus; tego, tegoprubart.
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.
Details of the oral presentation at the International Congress of The Transplantation Society are below:
Title: Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection
Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview
Session Title: Novel immunosuppression
Session Date and Time: Tuesday, September 22, 2026, from 8:00 a.m. to 9:00 a.m. AEST
Session Room: Room C4.9
Presentation Time: 8:00 a.m. AEST
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Specifically, our ability to achieve our anticipated future development and corporate milestones depends on our ability to obtain additional financing on acceptable terms. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com
Source: Eledon Pharmaceuticals, Inc
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/48a2ff2b-c346-426c-a886-6377e5c48d1a
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What clinical endpoints showed benefit for tegoprubart in the BESTOW extension study?
Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR) at months 18, 21, and 24, with an approximately 13 mL/min/1.73 m² advantage versus tacrolimus at month 24 (71 vs. 58 mL/min/1.73 m²; 95% CI: 2.6, 23.3). There were no reported cases of biopsy-proven acute rejection in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm. One new graft loss was observed in the tacrolimus arm.
What benefits can Eledon expect from the FDA Fast Track designation for tegoprubart?
The Fast Track process is designed to facilitate development and expedite 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.
What is planned for the Phase 3 LEGACY trial of tegoprubart in kidney transplantation?
The planned global Phase 3 LEGACY trial is expected to start in the fourth quarter of 2026 and enroll approximately 600 patients undergoing kidney transplantation. The primary endpoint is non-inferiority of tegoprubart versus tacrolimus on a composite efficacy failure endpoint at 12 months, defined as a combination of biopsy-proven acute rejection, graft loss, and death.
Where and when were the updated BESTOW data presented?
The updated Phase 2 BESTOW and BESTOW EXTENSION data were presented as an oral talk titled “Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection” during the “Novel immunosuppression” session at the International Congress of The Transplantation Society in Sydney, Australia, on Tuesday, September 22, 2026, from 8:00 a.m. to 9:00 a.m. AEST in Room C4.9, with a presentation time of 8:00 a.m. AEST.