Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2026 Outlook

Rhea-AI Summary

Eledon Pharmaceuticals (Nasdaq: ELDN) summarized 2025 progress and provided a 2026 outlook centered on tegoprubart development across kidney allotransplantation, islet transplantation and xenotransplantation. Key 2025 results: Phase 2 BESTOW showed a mean eGFR of 69 mL/min/1.73 m² (n=51) at 12 months and demonstrated non-inferiority versus tacrolimus on an efficacy-failure composite (22.2% vs. 17.2% using a 20% non-inferiority margin). Investigator-led islet transplants (UChicago) reported insulin independence in the first six patients. Tegoprubart was used in four pig-to-human xenotransplants (three at MGH). The company completed a $57.5 million financing, expected to fund operations into 2Q 2027. Anticipated 2026 milestones include FDA guidance on Phase 3 design and multiple long-term data readouts.

Positive

• Mean eGFR 69 mL/min/1.73 m² at 12 months (n=51)
• Non-inferiority vs tacrolimus on efficacy-failure composite (22.2% vs 17.2%)
• First six T1D islet-transplant patients achieved insulin independence
• $57.5 million financing expected to fund operations into 2Q 2027
• Tegoprubart used in four pig-to-human xenotransplants, including three at MGH

Negative

• Efficacy-failure rate higher with tegoprubart (22.2%) than tacrolimus (17.2%)
• Phase 3 initiation contingent on FDA guidance and regulatory alignment
• Public offering may be dilutive to existing shareholders

Key Figures

eGFR at 12 months 69 mL/min/1.73 m² Phase 2 BESTOW kidney transplant trial tegoprubart arm (n=51)

Sample size 51 patients Tegoprubart-treated cohort in Phase 2 BESTOW at 12 months

Composite endpoint 22.2% vs 17.2% Efficacy failure including rejection: tegoprubart vs tacrolimus, 20% NI margin

Financing amount $57.5 million Underwritten public offering of common stock and pre-funded warrants

Runway guidance into 2Q 2027 Financing expected to support company operations

Initial T1D cohort 6 patients First six type 1 diabetes patients post-islet transplant on tegoprubart

Total islet transplants 8 patients Islet transplantation with tegoprubart as core immunosuppressant

Follow-up duration 24 months Phase 1 extension study kidney transplant outcomes to be presented at ASTS

Market Reality Check

$1.73 Last Close

Volume Volume 1,020,758 vs 20-day average 944,450 (relative volume 1.08x), showing slightly elevated trading interest ahead of this update. normal

Technical Shares at $1.71 trade 65.56% below the 52-week high of $4.965 and 26.67% above the 52-week low of $1.35, and remain below the 200-day MA of $2.76.

Peers on Argus

ELDN rose about 3.01% with modestly above-average volume, while no close peers appeared in the momentum scanner. Several related biotech names (e.g., NKTX, NVCT) showed gains between roughly 2–7%, but this activity was not flagged as a coordinated sector momentum event.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 01	Conference participation	Neutral	-6.1%	Announced CEO participation in Piper Sandler healthcare conference fireside chat.
Nov 18	Clinical trial update	Positive	-4.9%	Reported first six T1D islet transplant patients all achieved insulin independence on tegoprubart.
Nov 14	Earnings & pipeline	Positive	-8.0%	Q3 results with BESTOW data supporting Phase 3 plans and $57.5M financing for programs.
Nov 12	Offering priced	Negative	-11.3%	Priced $50M underwritten public offering of common stock and pre-funded warrants.
Nov 11	Offering proposed	Negative	-5.3%	Announced proposed underwritten offering of common stock and pre-funded warrants.

Pattern Detected

Recent history shows negative price reactions to positive clinical/operational news, while dilution-related offerings aligned with share price declines.

Recent Company History

Over the last six months, Eledon has focused on advancing tegoprubart and securing funding. In November 2025, it reported Phase 2 BESTOW data with favorable kidney function and moved toward Phase 3, while raising $57.5 million through an underwritten offering. Preliminary islet transplant data in type 1 diabetes on Nov 18, 2025 were also positive. However, shares fell after these updates, and also declined on the Nov 11–12 offering announcements. Today’s milestone and 2026 outlook release occurs against this backdrop of clinically constructive news but pressured share performance.

Market Pulse Summary

This announcement consolidates Eledon’s 2025 progress and 2026 plans for tegoprubart across kidney transplantation, islet transplantation and xenotransplantation. Key points include Phase 2 BESTOW data with 12‑month eGFR of 69 mL/min/1.73 m², non‑inferiority to tacrolimus, insulin independence in the first six type 1 diabetes patients, and a $57.5 million financing expected to fund operations into 2Q 2027. Investors may track upcoming Phase 1/2 readouts, FDA guidance on Phase 3 design, and initiation of new investigator-led transplant studies.

Key Terms

calcineurin inhibitors medical

"Results demonstrated prevention of islet rejection without calcineurin inhibitors (CNIs), such as..."

Calcineurin inhibitors are a class of drugs that lower immune system activity by blocking a protein (calcineurin) that helps immune cells switch on. They are commonly used to prevent organ-transplant rejection and to treat some autoimmune conditions; news about clinical trial results, regulatory approvals, safety concerns, or patent changes can directly affect sales prospects and company valuations, like a dimmer switch that controls how strongly the body’s defenses respond.

xenotransplant medical

"patient who received a xenotransplant of a genetically modified pig kidney, conducted at..."

Xenotransplant is the practice of transplanting cells, tissues, or organs from one species into another, most often using animal organs in humans to replace failing biological parts. For investors, it matters because success could create large markets for new medical devices, drugs and surgical services, while also bringing regulatory, ethical and safety risks that can affect company value much like a new technology transforming an entire industry — similar to replacing a worn machine with a foreign-made part that may improve output but raise compatibility and warranty concerns.

islet transplantation medical

"treated with tegoprubart as the core immunosuppressant following islet transplantation in an..."

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.

anti-CD40L antibody medical

"Recipients Treated with Tegoprubart, an Anti-CD40L Antibody, as the Core Immunosuppression..."

An anti-CD40L antibody is a laboratory-made protein that binds to CD40 ligand, a molecule that helps turn immune responses on or off, and by doing so it dampens or reprograms parts of the immune system. Investors pay attention because these drugs target diseases like autoimmune conditions or transplant rejection, so clinical trial outcomes, safety signals, and regulatory decisions can sharply affect a developer’s market value, similar to how a promising new engine can change an automaker’s prospects.

pre-funded warrants financial

"Completed a $57.5 million underwritten public offering of common stock and pre-funded warrants..."

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

underwritten public offering financial

"Completed a $57.5 million underwritten public offering of common stock and pre-funded warrants..."

An underwritten public offering is when a company sells new shares of its stock to the public with the help of a financial firm, called an underwriter. The underwriter agrees to buy all the shares upfront, reducing the company's risk, and then sells them to investors. This process helps companies raise money quickly and confidently from a wide range of buyers.

Phase 3 medical

"supporting advancement into Phase 3 development Reported positive preliminary results..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

Phase 2 BESTOW trial data evaluating tegoprubart in kidney transplantation showed favorable efficacy, safety and tolerability, supporting advancement into Phase 3 development

Reported positive preliminary results from first six patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study

Tegoprubart continues to be used as key component of immunosuppression regimen in xenotransplants, including three transplants of a genetically modified pig kidney into a human at Massachusetts General Hospital

Completed $57.5 million financing, with funds expected to support operations into 2Q 2027

IRVINE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2025 accomplishments and provided guidance for anticipated upcoming 2026 business milestones.

“2025 was a significant year for Eledon as we achieved multiple key milestones across our tegoprubart clinical programs in kidney allotransplantation, islet transplantation and xenotransplantation. We were particularly encouraged by results from our Phase 2 BESTOW trial, presented at ASN Kidney Week in November, which further validated the favorable safety and tolerability profile of tegoprubart, reducing the metabolic, neurologic and cardiovascular toxicities commonly associated with tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We look forward to engaging with regulatory authorities, including the FDA, as we advance tegoprubart into Phase 3 development this year, with the goal of delivering a safer alternative to tacrolimus-based immunosuppression. We also remain focused on expanding the potential of tegoprubart to address broader challenges such as organ shortages and type 1 diabetes and look forward to providing additional updates throughout the year.”

2025 Key Highlights

• Presented results from the Phase 2 BESTOW clinical trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX. Tegoprubart demonstrated a favorable safety and tolerability profile, reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus, the current standard of care in immunosuppression therapy. Kidney function, as measured by estimated glomerular filtration rate (eGFR), for study participants treated with tegoprubart was 69 mL/min/1.73 m² (n=51) at 12 months, delivering what the Company believes is the highest mean eGFR level reported to date in larger kidney transplant clinical trials evaluating rejection prevention. The efficacy failure composite endpoint including rejection rate was 22.2% in the tegoprubart group vs. 17.2% in the tacrolimus group demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The data support the advancement of tegoprubart into Phase 3 clinical development as a potential new standard immunosuppression approach for the prevention of organ rejection in patients undergoing kidney transplantation.
  
• Reported positive preliminary results from the first six patients with type 1 diabetes (T1D) treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine’s Transplant Institute. All six treated patients achieved insulin independence with marked improvements in glycemic control after one or two transplants, with the first three remaining insulin-free for more than one year after transplant. Results demonstrated prevention of islet rejection without calcineurin inhibitors (CNIs), such as tacrolimus, and sustained insulin-free HbA1c control. To date, a total of eight patients have undergone islet transplantation with tegoprubart as the core immunosuppressant, and one additional patient with CNI-associated nephrotoxicity was transitioned to tegoprubart from tacrolimus.
  
• Announced the use of tegoprubart as a cornerstone component of the immunosuppression treatment regimen in a patient who received a xenotransplant of a genetically modified pig kidney, conducted at Massachusetts General Hospital (MGH) in collaboration with eGenesis. This procedure marked the fourth use of tegoprubart in a pig-to-human xenotransplant and the third use at MGH.
  
• Completed a $57.5 million underwritten public offering of common stock and pre-funded warrants, which is anticipated to support company operations into the second quarter of 2027.
  

Anticipated 2026 Milestones

• Present 24-month data from eight patients in Phase 1 extension study evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons (ASTS) Winter Symposium in Phoenix, AZ. Details are below:
  
  Title: Long-Term Outcomes of a Phase 1, Single Arm Cohort of De Novo Kidney Transplant Recipients Treated with Tegoprubart, an Anti-CD40L Antibody, as the Core Immunosuppression Regimen
  Abstract ID: #44
  Session Title: Poster Session B
  Date: Friday, January 23, 2026, from 5:45 - 7:15 p.m. PT

• Receive U.S. Food & Drug Administration (“FDA”) guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
  
• Report long-term data from the Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
  
• Report updated data from T1D patients in the investigator-led islet cell transplantation study evaluating tegoprubart at UChicago Medicine.
  
• Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.
  
• Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
  
• Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
  
• Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.
  

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, 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 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 establish and maintain proper and effective internal control over financial reporting and other risks disclosed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 14, 2025. 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 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

What were the Phase 2 BESTOW kidney transplant results announced by Eledon (ELDN) on January 8, 2026?

BESTOW reported a mean eGFR of 69 mL/min/1.73 m² at 12 months (n=51) and a non-inferiority efficacy-failure result of 22.2% vs 17.2% versus tacrolimus using a 20% margin.

How did tegoprubart perform in the University of Chicago islet transplant study for type 1 diabetes (ELDN)?

The first six treated patients achieved insulin independence with marked glycemic improvement; a total of eight patients have received islet transplants with tegoprubart to date.

What financing did Eledon (ELDN) complete and how long is it expected to fund operations?

Eledon completed a $57.5 million underwritten public offering, which is anticipated to support company operations into 2Q 2027.

What regulatory and clinical milestones does Eledon (ELDN) expect in 2026 for tegoprubart?

Eledon expects to receive FDA guidance on Phase 3 design for kidney transplantation, present long-term Phase 1/2 data, and report updated islet-transplant and xenotransplant regulatory guidance in 2026.

How has tegoprubart been used in xenotransplantation according to Eledon (ELDN)?

Tegoprubart has been a core immunosuppressant in four pig-to-human xenotransplants, including three procedures at Massachusetts General Hospital.