Eledon Pharmaceuticals, Inc. (ELDN), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Tegoprubart for the prevention of allograft rejection in liver transplantation.
Following the news, ELDN is up 4.69% at $3.03.
Tegoprubart, Eledon Pharma's lead investigational product, is an anti-CD40L antibody with high affinity for CD40L, a biological target with broad therapeutic potential.
Notably, Tegoprubart has 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.
Based on the encouraging preclinical evidence they generated to date, they believe liver transplantation represents a significant incremental opportunity for Tegoprubart, and they look forward to evaluating its potential in the clinical setting through an anticipated investigator-sponsored trial initiating later this year, commented David-Alexandre C. Gros, MD, Chief Executive Officer of Eledon.
He also added, "The clinical studies in kidney transplantation have demonstrated that Tegoprubart has the potential to improve graft survival and function while reducing the side effects associated with calcineurin inhibitors, supporting its promise as a novel immunosuppressive therapy across multiple organ transplant settings"
The Phase 2 BESTOW trial evaluating Tegoprubart in kidney transplantation is a 12-month, randomised, head-to-head trial enrolling 127 kidney transplant recipients, 63 receiving Tegoprubart and 64 receiving Tacrolimus across 44 global sites.
Phase 2 BESTOW trial data released in November 2025, showed favourable efficacy, safety and tolerability, supporting advancement into Phase 3 development.
In 2026, the firm looks forward to report long-term data from the Phase 1 and Phase 2 BESTOW studies evaluating Tegoprubart in kidney transplantation.
Based on the knowledge of anti-CD40 Ligand biology, Eldon is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS).
Recently, the firm reported completing a $57.5 million underwritten public offering of shares and pre-funded warrants, which is expected to support company operations through the second quarter of 2027.
ELDN has traded between $1.35 and $4.60. The stock closed Monday's trade at $2.90.
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