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

Eledon (NASDAQ: ELDN) reported updated investigator-initiated islet transplant data presented March 2026 from a 12-patient UChicago Medicine cohort treated with tegoprubart.

Rhea-AI Summary

Eledon (NASDAQ: ELDN) reported updated investigator-initiated islet transplant data presented March 2026 from a 12-patient UChicago Medicine cohort treated with tegoprubart. All 10 patients >4 weeks post-transplant achieved insulin independence and mean HbA1c ~5.35%. No rejection, no de novo donor-specific HLA antibodies, and no nephrotoxicity, hypertension or neurotoxicity were observed. Tegoprubart was generally well tolerated and immunosuppression-related adverse events were managed by lowering mycophenolic acid dose.

Findings support CD40L blockade as a calcineurin inhibitor-free option for islet graft protection and inform planned regulatory engagement later in 2026.

Positive

• 10/10 patients >4 weeks post-transplant achieved insulin independence
• Mean most recent HbA1c ~5.35% across the 10 insulin-independent patients
• No rejection episodes and no de novo donor-specific HLA antibodies observed
• No evidence of nephrotoxicity, hypertension, or neurotoxicity linked to tegoprubart regimen

Negative

• Small cohort of 12 patients limits statistical generalizability
• Average follow-up of approximately 8 months provides limited longer-term durability data

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On Mar 16, the day this news came out, ELDN closed 1.86% above the previous close.

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Key Figures

Cohort size: 12 patients Post-transplant duration: approximately 8 months Insulin independence: 10 patients (100%) +4 more

Cohort size

12 patients

Investigator-initiated allogeneic islet transplant trial

Post-transplant duration

approximately 8 months

Average time since islet transplant across 12-patient cohort

Insulin independence

10 patients (100%)

Patients >4 weeks post-transplant achieving insulin independence

Diabetes duration

approximately 33 years

Median duration of type 1 diabetes before transplantation

Baseline HbA1c

approximately 8.0%

Mean hemoglobin A1C prior to transplantation

Target HbA1c

below 6.0%

Most recent HbA1c for all 10 insulin-independent patients

Mean follow-up HbA1c

approximately 5.35%

Mean most recent HbA1c across 10 insulin-independent patients

Historical Context

5 past events · Latest: Mar 10

5 events

1. Mar 10

   Orphan designation

   24h Move

   +0.0%

   FDA granted orphan drug designation for liver transplant allograft rejection.

2. Mar 09

   Collaboration deal

   24h Move

   +4.3%

   Strategic collaboration with NewcelX pairing NCEL-101 with tegoprubart.

3. Mar 04

   Conference appearance

   24h Move

   +4.4%

   Participation in Leerink Global Healthcare Conference with fireside chat webcast.

4. Feb 05

   Conference appearance

   24h Move

   +11.2%

   Guggenheim biotech summit fireside chat and webcast announcement.

5. Jan 23

   Clinical data update

   24h Move

   -4.0%

   24‑month Phase 1b kidney transplant data showing sustained graft function and safety.

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

Key Terms

allogeneic, hemoglobin A1C, monoclonal antibody, calcineurin inhibitor, +4 more

8 terms

allogeneic medical

"adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation"

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

hemoglobin A1C medical

"mean hemoglobin A1C (“HbA1C”) of approximately 8.0% prior to transplantation"

A1c is a blood test that shows the average level of blood sugar over the previous two to three months, similar to a three-month average on a utility bill rather than a single daily reading. Investors care because A1c is a primary measure used to judge how well diabetes treatments and devices work, influences regulatory approvals, clinical trial success, reimbursement decisions, and the size of markets for related therapies and diagnostics.

monoclonal antibody medical

"tegoprubart, Eledon’s anti-CD40L monoclonal antibody, as part of a calcineurin inhibitor-free"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

calcineurin inhibitor medical

"as part of a calcineurin inhibitor-free immunosuppression regimen"

A calcineurin inhibitor is a drug that reduces the immune system by blocking the enzyme calcineurin, which helps immune cells send activation signals. Think of it like turning down an over-sensitive alarm system so the body won’t attack a transplanted organ or overreact in autoimmune disease. Investors care because these drugs carry major market value, regulatory and safety scrutiny, patent and pricing issues, and potential for long-term use or side-effect-driven liabilities that affect company revenues.

donor-specific HLA antibodies medical

"no patients developed de novo donor-specific HLA antibodies"

Donor-specific HLA antibodies are immune proteins made by a transplant recipient that target the donor’s HLA molecules — the cellular “ID tags” that help the body recognize its own tissue. They matter to investors because their presence raises the risk that a transplanted organ or cell therapy will be rejected, which can influence clinical trial success, regulatory decisions, market adoption, and the financial outlook for companies developing transplants, diagnostics, or anti-rejection treatments.

nephrotoxicity medical

"no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated"

Nephrotoxicity is damage to the kidneys caused by a drug, chemical or other substance that impairs their ability to filter waste and balance fluids. Investors care because evidence of kidney harm can delay or block regulatory approval, increase development and legal costs, and reduce a product’s market potential—like discovering a car has an engine flaw late in production that shrinks sales and raises repair bills.

immunosuppression medical

"as part of a calcineurin inhibitor-free immunosuppression regimen"

Immunosuppression is the lowering of the immune system’s ability to fight infections and other threats, either from drugs, medical treatments, or underlying disease. For investors it matters because products or conditions that cause immunosuppression change a drug’s safety profile, patient eligibility, regulatory hurdles and market size—think of it like turning down a building’s alarm system, which can reduce false alarms but raises the risk of real break‑ins and affects downstream costs and demand.

islet transplantation medical

"type 1 diabetes undergoing allogeneic islet transplantation at UChicago Medicine"

Islet transplantation is a medical procedure that moves clusters of insulin-producing cells (islets) from a donor into a patient to restore the body’s natural ability to regulate blood sugar. For investors, it matters because successful, scalable islet therapies can create new markets for biotech drugs, cell processing services and medical devices, change long-term treatment costs and reimbursement patterns, and trigger regulatory milestones that affect company value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- 12-patient cohort fully enrolled with an average time since transplant of approximately 8 months

- 100% insulin independence achieved in 10 patients who are over 4 weeks post-transplant

- No signs of graft rejection or de novo donor-specific HLA antibodies

- Tegoprubart continues to demonstrate a favorable safety and tolerability profile

IRVINE, Calif, March 16, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute and presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the Advanced Technologies and Treatments for Diabetes (ATTD) conference, held March 11-14, 2026 in Barcelona, Spain.

The investigator-initiated pilot study enrolled 12 adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation at UChicago Medicine. Patients had a median duration of diabetes of approximately 33 years and mean hemoglobin A1C (“HbA1C”) of approximately 8.0% prior to transplantation. Participants received tegoprubart, Eledon’s anti-CD40L monoclonal antibody, as part of a calcineurin inhibitor-free immunosuppression regimen.

The data demonstrated rapid improvement in glycemic control following islet transplantation, with stable islet graft function observed across the cohort. All 10 patients who were more than four weeks post-transplant achieved both insulin independence and a most recent HbA1c below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors.

“T1D patients have been waiting decades for a potential functional cure, and it is very encouraging to see meaningful progress in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “These latest findings support the potential of tegoprubart to enable effective islet graft protection while avoiding the toxicities often associated with calcineurin inhibitors, and potentially enable access to islet cell transplantation for individuals living with T1D. We are proud to contribute to these important ongoing research efforts and support the work of Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

"Breakthrough T1D is proud to fund the University of Chicago’s clinical trial testing tegoprubart as a novel immunosuppression alternative for use in islet cell transplants and we are very encouraged by the early data,” said Aaron Kowalski, Ph.D., CEO of Breakthrough T1D. “It is exciting to see islet transplant recipients in this trial who no longer need to administer insulin and who are experiencing fewer side effects than with traditional immunosuppressive regimens."

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

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 allograft 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; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, 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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. 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 significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, 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

FAQ

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

What were the key outcomes of Eledon (ELDN) tegoprubart in the UChicago islet transplant trial?

All 10 patients more than four weeks post-transplant achieved insulin independence and mean HbA1c ~5.35%. According to the company, the 12-patient study showed no rejection, no de novo donor-specific HLA antibodies, and a favorable tolerability profile with manageable immunosuppression-related events.

How many patients in the ELDN UChicago study became insulin independent and when was data presented?

Ten patients achieved insulin independence among those beyond four weeks post-transplant. According to the company, updated results were presented March 11–14, 2026, at the ATTD conference in Barcelona by the UChicago team.

Does tegoprubart cause common tacrolimus toxicities in the ELDN islet transplant data?

No evidence of tacrolimus-associated nephrotoxicity, hypertension, or neurotoxicity was observed in this cohort. According to the company, tegoprubart-based, calcineurin inhibitor-free regimens avoided those toxicities in the reported patients.

Were there any rejection episodes or donor-specific antibodies in the ELDN tegoprubart trial?

There were no rejection episodes and no patients developed de novo donor-specific HLA antibodies in the reported cohort. According to the company, these findings support CD40L blockade for islet graft protection without observed alloimmune activation.

What are the main limitations of the Eledon (ELDN) investigator-initiated islet transplant results?

The trial enrolled 12 patients with an average time since transplant of about eight months, limiting long-term conclusions. According to the company, larger and longer studies are needed to confirm durability and broader safety.