NCEL News & Events

NewcelX (NCEL) announced the completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration. The agency provided constructive feedback and alignment on the company's proposed development strategy, providing clarity regarding the regulatory pathway toward launching a clinical trial of NCEL-101 for type 1 diabetes in combination with Eledon Pharmaceuticals' (ELDN) anti-CD40L antibody, tegoprubart, an investigational immunomodulatory agent. The meeting results represent a significant milestone toward the clinical development of an innovative treatment paradigm targeting a potential functional cure for type 1 diabetes. The FDA provided favorable feedback on NewcelX's Chemistry, Manufacturing, and Controls processes and preclinical program allowing the Company to proceed toward its Investigational New Drug enabling activities.

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.

NewcelX files to sell 2.26M common shares for holders

NewcelX (NCEL) announced the release of an updated corporate presentation that includes the company's strategic collaboration with Eledon Pharmaceuticals (ELDN) and highlights the advancement of its flagship Type 1 Diabetes program, NCEL-101, as a central pillar of the company's development strategy. The updated presentation outlines the integration of NewcelX's scalable stem-cell-derived islet replacement platform with Eledon's investigational anti-CD40L monoclonal antibody tegoprubart, a targeted immune-modulation therapy designed to prevent immune-mediated transplant rejection. NewcelX believes this combined approach represents a promising strategy to support durable graft survival and advance the development of a potential functional cure for Type 1 Diabetes.