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

Tegoprubart showed greater symptom improvement in 22 of 23 domains where differences in improvement were observed.

Rhea-AI Summary

Eledon Pharmaceuticals (ELDN) presented Phase 2 BESTOW data showing improved patient-reported outcomes with tegoprubart versus tacrolimus after kidney transplantation. The results were presented at American Society of Nephrology Kidney Week 2026. Baseline scores were similar between groups.

At Month 12, the KDQOL-SF symptoms and problems score, measuring kidney disease-related symptom burden, improved by 9.0 points with tegoprubart versus 3.3 with tacrolimus (p<0.05). The difference was clinically and statistically significant. On a separate transplant symptom assessment, tegoprubart patients reported reduced symptom occurrence at Months 6 and 12; tacrolimus patients improved initially but were slightly above baseline at Month 12. The SF-12 mental health summary score rose 1.5 points with tegoprubart versus a 1.6-point decline with tacrolimus. Tegoprubart remains an investigational therapy.

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Positive

• Moderate pointMonth 12 symptom-score improvement reached 9.0 versus 3.3 points with tacrolimus, clinically and statistically significant (p<0.05).
• Minor pointTegoprubart symptom occurrence fell at Months 6 and 12; tacrolimus returned slightly above baseline at Month 12.
• Minor pointTegoprubart showed greater symptom improvement in 22 of 23 domains where differential improvement was observed.
• Minor pointTacrolimus showed greater symptom worsening in 22 of 22 domains where differential worsening was observed.
• Minor pointTegoprubart patients improved from baseline across all five KDQOL-SF subscales through Month 12.
• Minor pointMental health summary scores rose 1.5 points with tegoprubart versus a 1.6-point decline with tacrolimus.

Negative

• None.

Key Figures

Symptoms and Problems Scale change: 9.0 vs. 3.3 points; p<0.05 SF-12 mental component change: 1.5 vs. -1.6 points; 3.1-point between-group difference Domains with greater symptom improvement: 22 of 23 domains +2 more

Symptoms and Problems Scale change

9.0 vs. 3.3 points; p<0.05

Mean change from baseline at Month 12, tegoprubart vs. tacrolimus

SF-12 mental component change

1.5 vs. -1.6 points; 3.1-point between-group difference

Tegoprubart vs. tacrolimus

Domains with greater symptom improvement

22 of 23 domains

Where differential improvement was observed with tegoprubart

Domains with greater symptom worsening

22 of 22 domains

Where differential worsening was observed with tacrolimus

Clinically significant change threshold

3–5 points

KDQOL-SF scale

Previous Clinical trial Reports

2 past events · Latest: Sep 22

Same Type 2 events

1. Sep 22

   Phase 2 trial data

   24h Move

   +7.4%

   BESTOW extension reported higher eGFR and better patient-reported symptom scores versus tacrolimus.

2. Jun 22

   Phase 2 trial data

   24h Move

   -2.8%

   Long-term BESTOW extension reported higher eGFR, no late biopsy-proven rejection, and better symptom scores.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

kdqol-sf, hrqol, sf-12

3 terms

kdqol-sf medical

"Kidney Disease Quality of Life Short Form (KDQOL-SF)"

A patient-reported questionnaire that measures health-related quality of life for people with chronic kidney disease; KDQOL-SF combines the generic SF-36 health survey with kidney-disease–specific scales (symptoms, burden of kidney disease, effects of kidney disease, and others) to produce numeric scores reflecting physical, mental, and disease-specific wellbeing. It is used in clinical research and care to quantify how kidney disease and its treatments affect patients’ daily functioning and symptoms; it is a measurement tool, not a diagnostic test, and results are interpreted as scores or subscale comparisons rather than clinical diagnoses.

hrqol medical

"HRQoL, health-related quality of life"

Health-related quality of life (HRQoL) is a measure of how a person’s health condition and its treatment affect their daily functioning, symptoms, emotional well-being, and ability to do normal activities. For investors, HRQoL data matter because regulators, payers, and doctors often use these measures—alongside clinical outcomes—to judge a therapy’s real-world value, market acceptance, and potential reimbursement, similar to how customer satisfaction shapes demand for a product.

sf-12 medical

"SF-12, 12-item short-form survey"

A 12-item patient-reported questionnaire that measures overall health-related quality of life by producing two summary scores — a Physical Component Summary (PCS) and a Mental Component Summary (MCS). Respondents answer brief questions about physical functioning, pain, energy, emotional problems and general health; answers are converted to standardized scores (commonly normed so the population mean is 50 with a standard deviation of 10). It is an outcome measurement tool, not a diagnostic test, and is used to track changes in health status or compare groups in clinical, regulatory and commercial settings.

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Tegoprubart-treated patients demonstrated a mean improvement on the total MTSOSD-59R symptom occurrence scale at 12 months while tacrolimus-treated patients experienced a mean worsening of symptom occurrence

Statistically significant improvement on the KDQOL-SF Symptoms and Problems Scale among tegoprubart-treated patients through 12 months following kidney transplantation versus tacrolimus

Results further validate the differentiated clinical profile of tegoprubart and potential to transform standard of care in kidney transplantation

IRVINE, Calif., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced new positive patient-reported outcomes data from the Phase 2 BESTOW clinical trial of tegoprubart, its novel investigational immunosuppression therapy. The data showed significant, sustained improvements in health-related quality of life and symptom burden through 12 months compared with standard of care tacrolimus following kidney transplantation. The results were featured in an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026 Annual Meeting held October 21-25, 2026, in Denver, Colorado.

“The patient-reported outcomes presented at ASN Kidney Week provide perhaps the clearest picture yet of what tegoprubart’s differentiated profile means for transplant patients in everyday life,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We previously reported encouraging BESTOW results across efficacy, kidney function and safety measures, which alone strengthened our belief in tegoprubart. The additional findings presented demonstrate that these clinical outcomes were accompanied by substantial and importantly sustained improvements in quality of life and reductions in transplant-related symptom burden. Giving transplant patients an effective, safer and more tolerable alternative to tacrolimus addresses one of the most important unmet needs in organ transplantation, and collectively, these data further support the potential of tegoprubart to become a transformative new treatment option for kidney transplant recipients.”

“Success after kidney transplantation is measured not only by preventing rejection and preserving graft function, but also by how patients feel and function in their everyday lives,” said presenting author 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. “What is particularly compelling about these BESTOW results is the consistency of the patient-reported benefits when treated with tegoprubart compared with tacrolimus following kidney transplant. We observed broad improvements in quality-of-life measures together with remarkably favorable outcomes in transplant-specific symptom reporting. The extent of separation between treatment groups suggests patients receiving tegoprubart may experience meaningful quality of life advantages while maintaining strong clinical outcomes as previously reported from BESTOW.”

Patient-Reported Outcomes Results

Patient-reported outcomes were assessed using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) and the Kidney Disease Quality of Life Short Form (KDQOL-SF) Symptoms and Problems Scale, both validated measures of symptom burden. Baseline scores were similar between treatment groups. Collectively, the consistency of findings across both the KDQOL-SF and MTSOSD-59R assessments suggests that reductions in transplant-related symptom burden with tegoprubart may contribute to the improvements observed in patient-reported quality of life and further supports the differentiated clinical profile of tegoprubart compared to tacrolimus observed in the Phase 2 BESTOW clinical trial.

On the MTSOSD-59R assessment, tegoprubart-treated patients reported continued reductions in symptom occurrence from baseline at Months 6 and 12, whereas symptom occurrence in the tacrolimus arm initially declined through Month 6 before returning to slightly above baseline levels at Month 12.

Total MTSOSD-59R
Scores represent symptom occurrence
(higher scores reflect greater symptom occurrence)

^{CI, confidence interval; KDQOL-SF, Kidney Disease Quality of Life Short Form; MTSOSD-59R, Modified Transplant Symptom Occurrence Scale- 59 Items Revised; SEM, standard error of the mean; tac, tacrolimus; tego, tegoprubart.}

Tegoprubart demonstrated greater symptom improvement than tacrolimus in 22 of 23 domains where differential improvement was observed, including neurological, gastrointestinal, metabolic, and physical symptom categories. In addition, tacrolimus demonstrated greater symptom worsening in 22 of 22 domains where differential symptom worsening was observed.

On the KDQOL-SF assessment, kidney transplant patients treated with tegoprubart demonstrated improvements from baseline across all five subscales through Month 12. In the KDQOL-SF scale, a change of 3-5 points can be considered clinically significant, and tegoprubart was thus associated with a clinically and statistically significant improvement in the symptoms and problems subscale compared with tacrolimus at Month 12, with mean changes from baseline of 9.0 and 3.3 points, respectively (p<0.05). Consistent with these findings, the SF-12 mental component summary score increased by 1.5 points in the tegoprubart arm compared to a decline of 1.6 points in the tacrolimus arm, representing a 3.1-point between-group difference.

_{^a Higher scores indicate better HRQoL; a change of 3–5 points can be considered clinically significant¹. Baseline values were similar across all outcomes. *p < 0.05. HRQoL, health-related quality of life; KDQOL-SF, Kidney Disease Quality of Life Short-Form instrument; SEM, standard error of the mean; SF-12, 12-item short-form survey; tac, tacrolimus; tego, tegoprubart.1. KDOQI. Am J Kidney Dis 2007;50:471–530.}

Details of the oral presentation at ASN Kidney Week 2026 are below:

Title: Patient-Reported Outcomes in the Phase 2 BESTOW Trial Comparing Tegoprubart to Tacrolimus in Kidney Transplant Recipients
Presenter: Andrew B. Adams, M.D., Ph.D., Department of Surgery, University of Minnesota Medical School; Minneapolis, Minnesota
Abstract Publication Number: FR-OR084
Session Title: The Changing Landscape of Kidney Transplantation: Clinical Innovation, Outcomes, and Healthy Policy
Session Date and Time: Friday, October 23, 2026, from 4:30 p.m. to 6:00 p.m. MDT
Session Room: Mile High Ballroom 4A (Convention Center)
Presentation Time: 4:40 p.m. to 4:50 p.m. MDT

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.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

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

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/579abadf-4871-4465-9e03-706a758fa40e

https://www.globenewswire.com/NewsRoom/AttachmentNg/cb7f0d46-3ad7-4f31-a619-183f43abf9ed 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Eledon's BESTOW trial show about tegoprubart and kidney transplant symptoms?

At Month 12, tegoprubart improved the KDQOL-SF symptoms and problems score by 9.0 points from baseline versus 3.3 points with tacrolimus (p<0.05). The improvement was clinically and statistically significant. A separate transplant symptom assessment also showed reduced symptom occurrence with tegoprubart at Months 6 and 12.

What change in the quality-of-life scale used in Eledon's BESTOW trial is considered clinically significant?

A change of 3–5 points on the KDQOL-SF scale can be considered clinically significant.