Eledon Pharmaceuticals

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. » Más en 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. » Más en de.investing.com

Eledon presented 24-month follow-up data from eight patients in the phase‑1b study of tegoprubart in kidney transplantation. Mean eGFR increased from 67.0 ml/min/1.73 m² at 12 months to 74.2 ml/min/1.73 m² at 24 months; there were no biopsy‑confirmed acute rejection episodes, graft losses, deaths, new-onset diabetes, or donor-specific antibodies reported. Tegoprubart is an anti‑CD40L antibody being investigated as a non‑lymphocyte‑depleting immunomodulatory therapy. Financials show a solid balance sheet with a high current ratio and more cash than debt, providing runway for the clinical programs. » Más en de.investing.com