NewCelX Ltd. Submits Pre-IND Package to the FDA for NCEL-101 for the Treatment of Type 1 Diabetes

Pre-IND meeting has been scheduled with FDA to advance type 1 diabetes treatment to First-In-Human clinical trial

ZURICH, Switzerland, May 27, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced the submission of a Pre-Investigational New Drug (“Pre-IND”) briefing package to the U.S. Food and Drug Administration (“FDA”) to support the proposed First-In-Human (“FIH”) clinical trial of NCEL-101 in combination with tegoprubart, an investigational immunomodulatory agent being developed by Eledon Pharmaceuticals (“Eledon”; Nasdaq: ELDN). The submission represents a significant milestone toward the clinical development of an innovative treatment intended for a potential cure for type 1 diabetes.