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
Rhea-AI Summary
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.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Positive
- Tegoprubart mean eGFR ~12 mL/min/1.73 m² higher than tacrolimus at 18 months (74 vs. 61; p<0.05)
- No biopsy-proven acute rejection after six months in tegoprubart arm in Phase 2 and Phase 1b
- Statistically significant improvements in symptom burden scales versus tacrolimus at 52 weeks
- Key CNS and kidney-related adverse events numerically lower with tegoprubart than tacrolimus in extension
- No graft loss, PML, PTLD, BK or CMV nephropathy/disease, or new malignancies in extension study
- FDA End-of-Phase 2 meeting completed; Phase 3 kidney transplant program planned to start in late 2026
Negative
- One death occurred in the tegoprubart arm, although not attributed to study drug
- Acute kidney injury still reported in tegoprubart arm during extension (2% vs. 6% with tacrolimus)
- Diarrhea remained common in both arms during long-term follow-up (10% tegoprubart vs. 21% tacrolimus)
News Market Reaction – ELDN
On the day this news was published, ELDN gained 2.93%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.3% during that session. Argus tracked a trough of -3.2% from its starting point during tracking. Our momentum scanner triggered 37 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $10M to the company's valuation, bringing the market cap to $345.92M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 20 | BESTOW data preview | Positive | +1.3% | Announcement of upcoming long‑term Phase 2 BESTOW data presentations at ATC. |
| Mar 10 | Orphan designation | Positive | +0.0% | FDA Orphan Drug designation for liver transplant allograft rejection prevention. |
| Nov 06 | Phase 2 BESTOW data | Positive | -49.8% | First detailed Phase 2 BESTOW results in kidney transplantation at ASN Kidney Week. |
| Jul 17 | Phase 1b kidney update | Positive | -1.3% | Announcement of updated Phase 1b kidney transplant data at World Transplant Congress. |
| Sep 04 | BESTOW enrollment complete | Positive | -5.8% | Early completion of Phase 2 BESTOW enrollment ahead of schedule with 120 participants. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial headlines for ELDN have often seen muted or negative price reactions despite generally positive data.
Historical Comparison
In past clinical‑trial catalysts, ELDN moved an average of -11.13%. Ahead of today’s detailed BESTOW extension data, its pre‑event gain of about 6% stands out versus that typically negative pattern.
Same‑tag history shows steady progression: early BESTOW enrollment, Phase 1b updates, top‑line Phase 2 BESTOW data, new orphan designations, and now longer‑term BESTOW extension results supporting a Phase 3 program.
Regulatory & Risk Context
Short interest appears elevated, implying positioning that could contribute to higher volatility and the potential for sharp reversals if sentiment or news flow changes.
An effective S-3 shelf allows the company to raise up to $500,000,000, including via a $75,000,000 ATM, which increases future equity financing and potential dilution flexibility.
Key Terms
biopsy-proven acute rejection medical
kdqol-36 medical
non-inferiority medical
phase 3 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p<0.05)
No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (
Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden
Conference call and webcast to be held today at 8:00 a.m. ET
IRVINE, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced new long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented in oral and poster presentations at the American Transplant Congress (ATC) taking place June 20-24, 2026, in Boston, Massachusetts. The presentations highlight updated results from the Phase 2 BESTOW trial and new long-term follow-up data from the Phase 2 BESTOW extension study.
“These long-term data further strengthen our belief that tegoprubart has the potential to redefine the standard of care in transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “A statistically significant kidney function benefit at 18 months, no observed BPAR events after six months in tegoprubart-treated patients, favorable long-term safety and tolerability, and improved patient-reported outcomes collectively reinforce tegoprubart’s emerging, differentiated clinical profile as we prepare to advance into Phase 3 development.”
“For kidney transplant recipients, success is measured not only by preventing rejection, but by preserving kidney function and maintaining quality of life over the long term,” said 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. “These data are especially encouraging because tegoprubart was associated with sustained kidney function and improvements in patient-reported measures of symptom burden compared with tacrolimus. Providing an effective alternative to tacrolimus-based immunosuppression remains one of the most important unmet needs in kidney transplantation, particularly because lifelong immunosuppression can affect both long-term graft survival and how patients feel and function every day.”
Efficacy Results
- Among patients who completed 12 months of treatment in the BESTOW study,
96% (49/51) of tegoprubart-treated patients and86% (48/56) of tacrolimus-treated patients entered the BESTOW long-term extension study. As of the data cutoff, mean follow-up was 21 months, with: 89 patients followed through 18 months, 20 patients followed through 24 months, and the longest-followed ongoing patient followed for approximately 33 months. - Kidney graft function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month of treatment and remained higher in tegoprubart-treated patients than in tacrolimus-treated patients at each reported time point. At month 18, tegoprubart-treated patients demonstrated a statistically significant approximately 12 mL/min/1.73 m² higher mean eGFR compared with tacrolimus-treated patients (74 vs. 61 mL/min/1.73 m²; p<0.05).
- No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months of treatment. In the tacrolimus arm, seven of 11 total BPAR events (approximately
64% of BPAR events) occurred after six months, including two events after 12 months: one new case of active antibody-mediated rejection (aAMR) and one recurrent case of active T-cell-mediated rejection with aAMR. - Patient-reported outcome measures demonstrated lower symptom burden among tegoprubart-treated patients compared with tacrolimus-treated patients at 52 weeks, with statistically significant improvements on the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R; treatment difference: -12.2;
95% CI: -19.7, -4.6; p<0.05) and the KDQOL-36 Symptoms and Problems domain (treatment difference: 5.7;95% CI: 1.0, 10.5; p<0.05). - In an exploratory analysis of patients who experienced rejection post-transplant, those who remained on tegoprubart maintained higher mean eGFR than tacrolimus-treated patients who experienced rejection, with the observed difference increasing from approximately 15 mL/min/1.73 m² at 12 months to approximately 25 mL/min/1.73 m² at 21 months.
- Long-term follow-up from the Phase 1b study for patients treated at the 20 mg/kg dose of tegoprubart was consistent with the Phase 2 BESTOW results, with no BPAR episodes observed after six months in tegoprubart-treated patients. In the Phase 1b study, long-term data was available for 16 patients; eight patients have been followed through 24 months, and the longest-followed ongoing patient has been on tegoprubart for approximately 3.5 years.
Safety Results
- In the BESTOW long-term extension study, key central nervous system and kidney-related adverse events were observed more frequently in the tacrolimus arm than in the tegoprubart arm, including headache (
12% vs.2% ), extremity pain (10% vs.0% ), fall or loss of balance (6% vs.0% ), and acute kidney injury (6% vs.2% ), respectively. - Diarrhea was observed more frequently in the tacrolimus arm than in the tegoprubart arm during long-term follow-up (
21% vs.10% , respectively). This pattern was consistent with the first-year BESTOW results, in which diarrhea was reported in34% of tacrolimus-treated patients vs. in22% of tegoprubart-treated patients. - No graft loss, no progressive multifocal leukoencephalopathy (PML), no post-transplant lymphoproliferative disorder (PTLD), no BK or CMV nephropathy/disease, and no new malignancies were reported in the BESTOW long-term extension study. No new proteinuria was reported on the tegoprubart arm. One death occurred in the tegoprubart arm and was not attributed to study drug.
Next Steps
Following a successful FDA End-of-Phase 2 meeting, Eledon has established the regulatory framework for its Phase 3 kidney transplantation program and plans to initiate Phase 3 clinical development of tegoprubart in late 2026. The Phase 3 primary endpoint is expected to be non-inferiority versus tacrolimus at 52 weeks on a composite of BPAR, graft loss and death. The Phase 3 study will also incorporate key learnings from the Phase 2 BESTOW trial and ongoing long-term extension study, including evidence of sustained kidney function benefit, favorable rejection outcomes, and improved patient-reported outcomes.
Investor Conference Call Information
Eledon will hold a conference call today, June 22, 2026 at 8:00 a.m. Eastern Time to discuss the long-term data from the Phase 2 BESTOW and the Phase 1b kidney transplant clinical trials, as well as to discuss recently presented data from the on-going islet cell transplant investigator sponsored study. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 84665. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
Full details of the ATC oral presentation are below:
Title: Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy 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
Abstract Publication Number: 585
Session Title: Emerging Discoveries Oral Abstract Session - Kidney: Biomarkers -3
Session Date and Time: Monday, June 22, 2026, from 11:15 a.m. - 12:15 p.m. ET
Session Room: 253BC (Level 2)
Presentation Time: 12:03 p.m. - 12:15 p.m. ET
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-CD40 Ligand 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, the company’s capital resources and ability to finance planned 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. 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
