ELDN News & Events

NewcelX (NCEL) announced the submission of a pre-investigational new drug briefing package to the FDA to support the proposed first-In-human clinical trial of NCEL-101 in combination with tegoprubart, an investigational immunomodulatory agent being developed by Eledon Pharmaceuticals (ELDN). The submission represents a significant milestone toward the clinical development of an innovative treatment intended for a potential cure for type 1 diabetes.

"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, 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."

Eledon Pharmaceuticals files $500M mixed securities shelf