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 advances tegoprubart with an IND, new enrollments, supportive islet data and a reaffirmed timeline for the planned Phase 3 LEGACY kidney transplant trial.
Rhea-AI Summary
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.
Positive
- IND submitted for first company-sponsored, registrational islet cell transplantation trial in type 1 diabetes
- First patients enrolled in new investigator-initiated islet study using a calcineurin inhibitor–free tegoprubart regimen
- Compassionate-use dosing initiated in islet recipients with calcineurin inhibitor–related renal dysfunction and in highly sensitized kidney transplant patients
- UChicago islet study data: 12/12 patients achieved insulin independence, HbA1c < 7.0%, with stable graft function up to 22 months
- Favorable tolerability reported with no observed nephrotoxicity, hypertension, or neurotoxicity in the 12-patient islet cohort
- Phase 3 LEGACY kidney trial reaffirmed to start in Q4 2026, targeting ~600 patients with a 52-week non-inferiority endpoint vs. tacrolimus
Negative
- None.
Market Reaction – ELDN
Following this news, ELDN has gained 6.59%, reflecting a notable positive market reaction. The stock is currently trading at $3.19. Trading volume is very high at 3.6x the average, suggesting strong buying interest.
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Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 22 | Phase 2 BESTOW data | Positive | -2.8% | Long-term BESTOW data reported higher kidney function and planned Phase 3 progression. |
| May 20 | BESTOW presentation announcement | Neutral | +1.3% | Upcoming BESTOW data presentation at American Transplant Congress was announced for June 2026. |
| Mar 10 | Liver orphan designation | Positive | +0.0% | FDA granted Orphan Drug designation for tegoprubart in liver transplantation. |
| Nov 06 | Phase 2 BESTOW results | Positive | -49.8% | Phase 2 BESTOW results reported non-inferiority and differentiated safety findings. |
| Jul 17 | Phase 1b data presentation | Neutral | -1.3% | Updated Phase 1b kidney-transplant data presentation at World Transplant Congress was announced. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Among five tag-matched clinical-trial events, four had negative or zero 24-hour reactions despite positive or informational announcements.
Key Terms
anti-CD40L antibody medical
calcineurin inhibitor medical
hba1c medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes
First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant
First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction
First patients dosed under compassionate use of tegoprubart in highly sensitized patients with pre-existing antibodies receiving a kidney transplant
Company on track to initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026
IRVINE, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. The Company also reaffirmed that it remains on track to initiate LEGACY, its global Phase 3 clinical trial evaluating its investigational novel immunosuppression therapy tegoprubart, an anti-CD40L antibody, in patients undergoing kidney transplantation, in the fourth quarter of 2026.
“The progress announced today reflects the growing breadth and momentum of tegoprubart’s clinical development across multiple transplant settings as we work to redefine transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We remain on track to initiate our global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, while the submission of an IND for our first Company-sponsored islet cell transplantation study represents an important regulatory milestone for the tegoprubart program. In parallel, investigator-initiated studies and compassionate-use experience are expanding the clinical evaluation of tegoprubart into transplant populations with significant unmet needs, including in patients experiencing calcineurin inhibitor-related toxicities and in highly sensitized kidney transplant recipients who face elevated immunologic risk. These new programs are expected to generate important clinical insights and data updates over the next 12 months.”
Islet Cell Transplantation
- IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes. Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population.
- First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation.
- First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care.
- Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below
7.0% following islet cell transplantation and treatment with tegoprubart. Stable islet graft function was observed across all 12 study participants through a maximum reported follow-up of 22 months. Tegoprubart demonstrated a favorable tolerability profile, with no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus.
Kidney Transplantation
- Phase 3 LEGACY clinical trial on track to initiate in Q4 2026. 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 versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death.
- First highly sensitized kidney transplant patient dosed under compassionate use. The first highly sensitized kidney transplant patient has been dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. Highly sensitized patients requiring a kidney transplant face a substantial unmet need because pre-existing antibodies can significantly limit access to compatible donor organs and increase the risk of antibody-mediated rejection and graft loss post-transplant. The compassionate use of tegoprubart in this setting will help expand our clinical insights and understanding of tegoprubart’s potential in a particularly challenging patient population.
- Third patient treated in investigator-initiated kidney transplant tolerance study. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH). Tolerance induction has the potential to eliminate the need for patients to require lifelong immunosuppression therapy.
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, 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. 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 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 Report on Form 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 as 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
FAQ
What did Eledon Pharmaceuticals (ELDN) announce about its tegoprubart program on September 3, 2026?
Eledon reported multiple tegoprubart milestones, including an FDA IND submission for a registrational islet cell transplantation study, new investigator-initiated and compassionate-use enrollments in islet and kidney transplant settings, expansion of an islet trial at UChicago, and a reaffirmed Q4 2026 start for the Phase 3 LEGACY kidney transplant trial.
What is the new IND submission for tegoprubart in islet cell transplantation for ELDN?
Eledon submitted an IND to the FDA for a planned company-sponsored, registrational trial of tegoprubart to prevent allograft rejection in type 1 diabetes patients undergoing pancreatic islet cell transplantation. This would be the company’s first sponsored clinical trial in islet cell transplantation.
What clinical results were reported from the UChicago islet cell transplantation study with tegoprubart for ELDN?
In the ongoing UChicago investigator-initiated islet study, all 12 treated type 1 diabetes patients achieved insulin independence, had HbA1c below 7.0%, and showed stable islet graft function through up to 22 months. Tegoprubart showed a favorable tolerability profile without observed nephrotoxicity, hypertension, or neurotoxicity.
When will the Phase 3 LEGACY kidney transplant trial of tegoprubart for ELDN begin and what is its design?
Eledon states it remains on track to initiate the global Phase 3 LEGACY trial in Q4 2026. The study is expected to enroll approximately 600 kidney transplant patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection, graft loss, and death.
How is tegoprubart being used under compassionate use in transplant patients for ELDN?
Tegoprubart is being used under compassionate-use protocols for an islet cell transplant recipient converted from tacrolimus due to calcineurin inhibitor–related renal dysfunction and for a highly sensitized kidney transplant patient at Duke University. These uses aim to generate additional clinical insights in high-need populations.
What new investigator-initiated studies involving tegoprubart were highlighted by Eledon Pharmaceuticals (ELDN)?
Eledon highlighted a new investigator-initiated islet study at UChicago evaluating a calcineurin inhibitor–free tegoprubart regimen in type 1 diabetes patients with renal dysfunction and reported a third patient treated in an investigator-initiated kidney transplant tolerance induction study at Massachusetts General Hospital.
Why does Eledon Pharmaceuticals (ELDN) see tegoprubart as addressing unmet needs in transplantation?
The company states that tegoprubart may address unmet needs in transplant recipients who face calcineurin inhibitor–related toxicities, such as kidney damage, and in highly sensitized kidney transplant patients at elevated immunologic risk, with ongoing studies and compassionate-use cases designed to explore its potential in these challenging populations.