Eledon Pharmaceuticals

Eledon has filed an investigational new drug (IND) application with the FDA for a registration‑enabling study of the anti‑CD40L antibody Tegoprubart for immunosuppression in islet cell transplants for type 1 diabetes. The study would be Eledon’s first company‑sponsored trial in this area; investigator‑initiated studies are already underway at UChicago, Duke and MGH, and compassionate‑use treatments are also being provided. Earlier results in 12 treated patients showed insulin independence, HbA1c <7.0% and stable graft function for up to 22 months; Eledon also plans to start the global phase‑3 LEGACY study in kidney transplantation in Q4 2026 with about 600 patients. » More on de.investing.com

At the Leerink conference, Eledon Pharmaceuticals presented data on tegoprubart in kidney transplants, showing non‑inferiority to tacrolimus and a better safety profile, but no statistically significant superiority in kidney function. The company plans to finalize the phase‑3 study design with the FDA by year‑end and aims to start the trial within the year. Eledon received orphan‑drug designation for liver transplantation, is planning a liver‑related investigator‑sponsored trial (IST), and is evaluating expansion and strategic partnerships in islet‑cell transplantation. Cash on hand exceeds $130 million, providing a runway into the second quarter of next year. » More on de.investing.com

At the Guggenheim Summit Eledon Pharmaceuticals said Tegoprubart showed significant safety advantages in kidney transplant studies, but the phase‑2 BESTOW trial missed its primary endpoint for renal function. The company plans to start a registrational phase‑3 trial with a composite endpoint by the end of 2026 and intends to place greater emphasis on patient‑reported outcomes. Positive early results in islet‑cell transplantation are to be advanced into a sponsored study in 2026, with an IND filing planned by year‑end. Eledon has funding into the second quarter of 2027 and is also pursuing global collaborations in xenotransplantation. » More on de.investing.com