ELDN

100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026 IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights. “In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.” First Quarter 2026 Business Highlights In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care. The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extens...

NewcelX and Eledon Pharmaceuticals are collaborating to advance one of the few scalable approaches to a potential functional cure in Type 1 Diabetes, NCEL-101, as the flagship program and key long-term value driver toward IND-enabling milestones Substantially debt free, NewcelX recently closed a financing of up to approximately $3.4 million, including $1.35 million in cash and approximately $2 million of potential additional proceeds from the exercise of warrants, and has access to up to a $25 million Equity Line of Credit Strengthened scientific leadership with appointment of Julien Boisdron, MD, Chief Medical Officer of a Swiss Big Pharma, to Scientific Advisory Board Aims to significantly accelerate development progress of NCEL-101 and rest of clinical pipeline in 2026 ZURICH, Switzerland, April 30, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (Nasdaq: NCEL),– NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced reporting its financial results for the period ended December 31, 2025 and corporate highlights. “2025 was a transformative year for NewcelX, marked by completion of the merger, strengthening of our balance sheet and advancement of NCEL-101 together with our partner Eledon Pharmaceuticals (Nasdaq: ELDN) as our flagship program and key long-term shareholder value driver,” said Ronen Twito, Executive Chairman and Chief Executive Officer of NewcelX. “We believe our scalable stem cell-derived islet platform, combined with targeted immune protection, represents one of the few differentiated approaches aimed at a potential functional cure for Type 1 Diabetes. With our first post-merger annual results, strengthened capital structure and growing scientific validation, we expect 2026 to be a year of significantly accelerated execution.” Corporate and Program Highlights Advanced development of NCEL-101, Company’s flagship stem cell-derived islet therapy for Type 1 Diabetes. Continued IND-enabling development activities, including regulatory preparation and preclinical planning. Progress in manufacturing readiness, including clinical batches manufacturing preparations with CDMO, Pluri Inc., supporting continued development. Further development of clinical pipeline with advancement of a differentiated approach combining stem cell-derived islets with tegoprubart for targeted immune protect...

Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study Presented 24-month follow-up data from Phase 1b long-term extension study which continues to support the favorable safety and tolerability profile of tegoprubart Tegoprubart granted Orphan Drug designation by the FDA for the prevention of allograft rejection in liver transplantation IRVINE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2025 operating and financial results and reviewed recent business highlights. “Over the past year, Eledon has made significant progress advancing tegoprubart, our anti-CD40L antibody, as a potential next-generation immunosuppressive therapy across multiple transplantation settings,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The over 100 patients treated across our transplantation programs to date provide a growing body of evidence that reinforces our conviction that tegoprubart can address key safety and efficacy issues with current standard-of-care transplant immunosuppression. Looking ahead, we anticipate multiple important milestones this year, including regulatory engagement to support advancement into Phase 3 development in kidney transplantation, initiation of an additional islet transplantation trial in type 1 diabetes, and the start of a clinical trial in liver transplantation.” Fourth Quarter 2025 and Recent Corporate Developments Announced that tegoprubart has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of allograft rejection in liver transplantation. Tegoprubart previously received Orphan Drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS). Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-speci...

Data from Phase 2 BESTOW trial demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Data supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection Strengthened balance sheet with $57.5 million financing to advance transplantation programs IRVINE, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its third quarter 2025 operating and financial results and reviewed recent business highlights. “The results from our Phase 2 BESTOW trial demonstrated tegoprubart’s excellent efficacy and safety, importantly avoiding many of the long-term toxicities commonly seen with current standard-of-care immunosuppressive therapies,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Further, the proceeds from our recent financing enhance our ability to advance tegoprubart’s programs in kidney transplantation, islet cell transplantation, and xenotransplantation, addressing critical unmet needs in transplant medicine.” Third Quarter 2025 and Business Highlights Presented results from the Phase 2 BESTOW 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, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus. Kidney function, as measured by estimated glomerular filtration rate (eGFR), was approximately 69 mL/min/1.732 at 12-months for participants in the tegoprubart treatment arm (n=51). Based on the Phase 2 BESTOW results, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements. Insights from the Phase 2 BESTOW data set and the ongoing long-term extension study will be incorporated to optimize the Phase 3 protocol and strengthen the regulatory package. On November 13, 2025, Eledon completed an underwritten public offering of common stock and pre-funded warrants, resulting in total gross proceeds of $57.5 million and net proceeds of approximately $53.6 million afte...

Eledon Pharmaceuticals (ELDN) just shared results from its Phase 2 BESTOW trial on tegoprubart for kidney transplant rejection. While the main goal was not fully met, the data points to meaningful preservation of kidney function. See our latest analysis for Eledon Pharmaceuticals. Shares of Eledon Pharmaceuticals have taken a steep dive recently, with the share price dropping over 49% in a single day and more than 52% over the past week following news from the Phase 2 trial. This latest setback has added to what has been a tough 12 months for long-term holders, reflected in a 57% decline in total shareholder return, though the company’s advancement toward Phase 3 keeps the door open for a potential turnaround if clinical results improve and market sentiment shifts. If the ups and downs of biotech spark your curiosity, now is a good time to see what else is happening across the industry. See the full list for free. With the share price in freefall but analyst targets suggesting substantial upside, it is worth asking: are investors overlooking possible long-term value here, or is the market already factoring in all that future growth? Compared to its peers and the broader market, Eledon Pharmaceuticals is trading at a price-to-earnings ratio of 8.4x. This compares to the US market average of 18.1x and the US Biotechs industry average of 17x, making the current price appear undervalued by these benchmarks. The price-to-earnings (P/E) ratio indicates how much investors are willing to pay per dollar of earnings. In the biotech sector, this figure provides a snapshot of market confidence in a company’s ability to generate profits, especially after achieving profitability. Eledon’s P/E ratio is significantly below both the industry and peer averages. This suggests that either the market is not fully pricing in its profitability or has concerns about its growth prospects. Both the peer group average (16.9x) and the estimated fair P/E (10.7x) are materially higher, highlighting that the stock could see upward multiple expansion if sentiment shifts or fundamentals improve. Explore the SWS fair ratio for Eledon Pharmaceuticals Result: Price-to-Earnings of 8.4x (UNDERVALUED) However, further setbacks in clinical trials or continued weak financial results could easily undermine any momentum and keep investor confidence subdued. Find out about the key risks to this Eledon...

Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m² Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection Conference call to be held Friday, November 7 at 8:00 a.m. ET IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented today as a late breaking oral presentation titled “Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial,” at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX. “The Phase 2 BESTOW data results demonstrate tegoprubart’s potential to maintain excellent kidney function while reducing the chronic metabolic, neurologic, and cardiovascular toxicities that burden patients on tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “By pairing strong immunosuppressive efficacy with a differentiated safety profile, including dramatically lower rates of new-onset diabetes, tremor, and dialysis-requiring delayed graft function, tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase 3.” “There remains a significant unmet need for safer alternatives to traditional tacrolimus-based immunosuppression regimens—options that can reduce harmful side effects without compromising efficacy. The Phase 2 results presented at ASN Kidney Week highlight the potential of tegoprubart to deliver strong graft function after kidney transplantation, while avoiding the long-term toxicities often associated with current standard of care,” 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, Uni...

Conference call and webcast to discuss results to be held on November 7, 2025 at 8:00 a.m. ET IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the American Society of Nephrology’s upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025. The oral presentation will highlight topline results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation. Details of the oral presentation are below: Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial 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: TH-OR089 Session Title: Late-Breaking Research Orals - 1 Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT Session Room: Grand Ballroom C (Convention Center) Presentation Time: 5:30 p.m. to 5:42 p.m. CT Conference Call Eledon will hold a conference call on November 7, 2025 at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. 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. 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, immunomodulat...

Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025 Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025 IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights. “We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.” Year-to-Date 2025 Business Highlights Presented updated data at the World Transplant Congress (WTC) in August 2025 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 32 participants demonstrated that tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, sepsis, or new-onset diabetes. Kidney function, as assessed by estimated glomerular filtration rate (eGFR), generally stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for participants (n=12) who remained on tegoprubart. For comparison, data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFRs of approximately 53 mL/min/1.73 m2 at 12 months after kidney transplant. In June 2025, a third patient was treated with tegop...

On track to report topline results from Phase 2 BESTOW trial in kidney transplantation in fourth quarter of 2025 Tegoprubart used as a key component of immunosuppression regimen in its second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital Cash, cash equivalents and short-term investments of $124.9 million as of March 31, 2025 IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2025 operating and financial results and reviewed recent business highlights. “We continue to work diligently towards our goal of transforming the transplant treatment landscape and remain encouraged by the growing body of evidence supporting tegoprubart as a potential novel immunosuppression therapy to better protect transplanted organs,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The second half of the year is positioned to be a time of significant progress for Eledon, with multiple updates planned from our tegoprubart studies in kidney transplantation, beginning with new data from our open-label Phase 1b this summer. In addition, we remain on track to report topline results from the Phase 2 BESTOW trial in the fourth quarter of 2025, which we believe has the potential to demonstrate the superiority of tegoprubart over standard of care, as measured by estimated glomerular filtration rate (eGFR).” First Quarter 2025 and Business Highlights Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital on January 25, 2025. The patient was subsequently discharged from the hospital without need for continued treatment with dialysis for the first time in more than two years. Anticipated Upcoming Milestones August 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation. Late 2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine in subjects with type 1 diabetes treated with tegoprubart as part...

Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025 Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026 IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights. “We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.” Fourth Quarter 2024 and Recent Business Highlights Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years. Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant reject...