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Eledon files IND for islet cell trial, eyes Phase 3 kidney study

Thu, 03 Sep 2026 07:01:04 -0400

Eledon Pharmaceuticals (Nasdaq: ELDN) announced several clinical development milestones for its investigational drug tegoprubart, an anti-CD40L antibody, across kidney and islet cell transplantation programs, according to a company statement.

The Irvine, California-based company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a planned registrational clinical trial evaluating tegoprubart in type 1 diabetes patients undergoing pancreatic islet cell transplantation.

The company also reported that the first patients have been enrolled in an investigator-initiated study at the University of Chicago Medicine Transplant Institute evaluating a calcineurin inhibitor-free, tegoprubart-based regimen in patients with type 1 diabetes and chronic

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

Thu, 03 Sep 2026 07:00:00 -0400

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

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

Thu, 03 Sep 2026 07:00:00 -0400

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

Eledon Pharmaceuticals, Inc. (ELDN) Misses Q2 EPS by 12c

Thu, 13 Aug 2026 16:41:20 -0400

Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) reported Q2 EPS of ($0.27), $0.12 worse than the analyst estimate of ($0.15).
For earnings history and earnings-related data on Eledon Pharmaceuticals, Inc. (ELDN) click here.

Form 10-Q Eledon Pharmaceuticals, For: Jun 30

Thu, 13 Aug 2026 16:32:00 -0400
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Form 10-Q Eledon Pharmaceuticals, For: Jun 30

Thu, 13 Aug 2026 16:32:00 -0400
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Form 8-K Eledon Pharmaceuticals, For: Aug 13

Thu, 13 Aug 2026 16:10:00 -0400
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Form 8-K Eledon Pharmaceuticals, For: Aug 13

Thu, 13 Aug 2026 16:10:00 -0400
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Eledon Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Thu, 13 Aug 2026 16:05:00 -0400

Successful End-of-Phase 2 meeting with FDA supports advancement of tegoprubart into a global Phase 3 kidney transplantation trial, on track to initiate in late 2026

Long-term Phase 2 BESTOW data presented at ATC 2026 demonstrated sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus

Updated islet cell transplantation data presented at ADA 2026 showed 100% insulin independence in all 12 patients with type 1 diabetes

Cash, cash equivalents and short-term investments of $88.8 million as of June 30, 2026

IRVINE, Calif., Aug. 13, 2026

Eledon Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Thu, 13 Aug 2026 16:05:00 -0400

Successful End-of-Phase 2 meeting with FDA supports advancement of tegoprubart into a global Phase 3 kidney transplantation trial, on track to initiate in late 2026

Long-term Phase 2 BESTOW data presented at ATC 2026 demonstrated sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus

Updated islet cell transplantation data presented at ADA 2026 showed 100% insulin independence in all 12 patients with type 1 diabetes

Cash, cash equivalents and short-term investments of $88.8 million as of June 30, 2026

IRVINE, Calif., Aug. 13, 2026

Form 4 Eledon Pharmaceuticals, For: Jul 31 Filed by: Gros David-Alexandre C

Tue, 04 Aug 2026 17:23:00 -0400
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Form 4 Eledon Pharmaceuticals, For: Jul 31 Filed by: Gros David-Alexandre C

Tue, 04 Aug 2026 17:23:00 -0400
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Form 4 Eledon Pharmaceuticals, For: Jul 31 Filed by: Perrin Steven

Tue, 04 Aug 2026 17:22:00 -0400
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Form 4 Eledon Pharmaceuticals, For: Jul 31 Filed by: Perrin Steven

Tue, 04 Aug 2026 17:22:00 -0400
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Form SCHEDULE 13G Eledon Pharmaceuticals, Filed by: VANGUARD CAPITAL MANAGEMENT LLC

Fri, 31 Jul 2026 10:17:00 -0400
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Form SCHEDULE 13G Eledon Pharmaceuticals, Filed by: VANGUARD CAPITAL MANAGEMENT LLC

Fri, 31 Jul 2026 10:17:00 -0400
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Rodman & Renshaw Starts Eledon Pharamceuticals (ELDN) at Buy

Tue, 21 Jul 2026 06:31:07 -0400

Rodman & Renshaw analyst Seema Sheoran initiates coverage on Eledon Pharamceuticals (NASDAQ: ELDN) with a Buy rating and a price target of $12.00.
The analyst comments "We are initiating coverage of Eledon (ELDN) with a BUY rating and $12 price target, implying ~200% upside from current levels. Eledon is developing tegoprubart, an anti-CD40L antibody aiming to replace calcineurin inhibitor (CNI) based immunosuppression in transplant settings. The lead indication is de novo kidney transplantation, with Ph3 expected to start by the end of this year, and topline data anticipated ~2H29. A second value driver is islet-cell transplantation for type 1 diabetes, which

Rodman & Renshaw Starts Eledon Pharamceuticals (ELDN) at Buy

Tue, 21 Jul 2026 06:31:07 -0400

Rodman & Renshaw analyst Seema Sheoran initiates coverage on Eledon Pharamceuticals (NASDAQ: ELDN) with a Buy rating and a price target of $12.00.
The analyst comments "We are initiating coverage of Eledon (ELDN) with a BUY rating and $12 price target, implying ~200% upside from current levels. Eledon is developing tegoprubart, an anti-CD40L antibody aiming to replace calcineurin inhibitor (CNI) based immunosuppression in transplant settings. The lead indication is de novo kidney transplantation, with Ph3 expected to start by the end of this year, and topline data anticipated ~2H29. A second value driver is islet-cell transplantation for type 1 diabetes, which

NewcelX gets FDA feedback supporting NCEL-101 diabetes trial path

Wed, 01 Jul 2026 09:30:17 -0400

NewcelX Ltd. (Nasdaq: NCEL) announced it has completed a Type B Pre-IND meeting with the U.S. Food and Drug Administration, receiving feedback that supports the company's proposed development strategy for NCEL-101, its stem cell-derived islet product candidate for type 1 diabetes.

The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls processes and preclinical program, allowing the company to proceed toward Investigational New Drug enabling activities. The planned clinical trial would combine NCEL-101 with tegoprubart, an investigational anti-CD40L antibody developed by Eledon Pharmaceuticals (Nasdaq: ELDN).

Ronen Twito, CEO and Executive Chairman of NewcelX, said: "Coming out of our FDA meeting, we

NewcelX gets FDA feedback supporting NCEL-101 diabetes trial path

Wed, 01 Jul 2026 09:30:17 -0400

NewcelX Ltd. (Nasdaq: NCEL) announced it has completed a Type B Pre-IND meeting with the U.S. Food and Drug Administration, receiving feedback that supports the company's proposed development strategy for NCEL-101, its stem cell-derived islet product candidate for type 1 diabetes.

The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls processes and preclinical program, allowing the company to proceed toward Investigational New Drug enabling activities. The planned clinical trial would combine NCEL-101 with tegoprubart, an investigational anti-CD40L antibody developed by Eledon Pharmaceuticals (Nasdaq: ELDN).

Ronen Twito, CEO and Executive Chairman of NewcelX, said: "Coming out of our FDA meeting, we

NewcelX Announces Successful FDA Pre-IND Meeting with Clear Path Forward for NCEL-101 Toward Starting Clinical Trials for Type 1 Diabetes

Wed, 01 Jul 2026 09:30:00 -0400

FDA feedback supports NewcelX’s planned development strategy for NCEL-101 in combination with Tegoprubart
ZURICH, July 01, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, announced the successful completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration (“FDA”). The agency provided constructive feedback and alignment on the Company’s proposed development strategy, providing clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals’ (Nasdaq: ELDN) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent. The meeting results

NewcelX Announces Successful FDA Pre-IND Meeting with Clear Path Forward for NCEL-101 Toward Starting Clinical Trials for Type 1 Diabetes

Wed, 01 Jul 2026 09:30:00 -0400

FDA feedback supports NewcelX’s planned development strategy for NCEL-101 in combination with Tegoprubart
ZURICH, July 01, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, announced the successful completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration (“FDA”). The agency provided constructive feedback and alignment on the Company’s proposed development strategy, providing clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals’ (Nasdaq: ELDN) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent. The meeting results

Natera and Eledon partner on kidney transplant Phase 3 trial

Thu, 25 Jun 2026 07:00:23 -0400

Natera, Inc. (Nasdaq: NTRA) and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have announced a partnership to use Natera's Prospera kidney transplant assessment test in Eledon's planned Phase 3 clinical trial of tegoprubart, an investigational drug intended to prevent organ rejection in kidney transplantation.

Under the agreement, the Prospera test will serve as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in the trial. The study is expected to enroll approximately 600 kidney transplant recipients across more than 100 transplant centers globally, with trial initiation planned for late 2026.

Tegoprubart is an anti-CD40L antibody being developed as an alternative to current immunosuppressive therapies such

Natera and Eledon partner on kidney transplant Phase 3 trial

Thu, 25 Jun 2026 07:00:23 -0400

Natera, Inc. (Nasdaq: NTRA) and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have announced a partnership to use Natera's Prospera kidney transplant assessment test in Eledon's planned Phase 3 clinical trial of tegoprubart, an investigational drug intended to prevent organ rejection in kidney transplantation.

Under the agreement, the Prospera test will serve as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in the trial. The study is expected to enroll approximately 600 kidney transplant recipients across more than 100 transplant centers globally, with trial initiation planned for late 2026.

Tegoprubart is an anti-CD40L antibody being developed as an alternative to current immunosuppressive therapies such

Natera and Eledon partner on kidney transplant Phase 3 trial

Thu, 25 Jun 2026 07:00:23 -0400

Natera, Inc. (Nasdaq: NTRA) and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN) have announced a partnership to use Natera's Prospera kidney transplant assessment test in Eledon's planned Phase 3 clinical trial of tegoprubart, an investigational drug intended to prevent organ rejection in kidney transplantation.

Under the agreement, the Prospera test will serve as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in the trial. The study is expected to enroll approximately 600 kidney transplant recipients across more than 100 transplant centers globally, with trial initiation planned for late 2026.

Tegoprubart is an anti-CD40L antibody being developed as an alternative to current immunosuppressive therapies such