TORONTO and HAIFA, Israel, Feb. 02, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V), known as “NurExone,” is pleased to announce the initiation of the Orphan Drug Designation process with the European Medicines Agency (EMA) for its groundbreaking ExoPTEN product, currently in development for patients with acute spinal cord injury. This strategic move follows the recent grant of Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for ExoPTEN.
Dr. Ina Sarel, Head of CMC, Quality, and Regulation at NurExone Biologic, expressed enthusiasm about the development, stating, “Embarking on the European Orphan Drug Designation process marks a crucial milestone in our mission to bring life-changing treatments to patients in need around the world.”
The recent FDA approval of Orphan Drug Designation for ExoPTEN in the United States underscores the potential of Nurexone Biologic’s therapeutic approach in a field where treatment options are limited, and it is expected to yield significant market benefits for the Company. The initiation of the European Orphan Drug Designation process represents a strategic move to broaden the reach of this promising treatment globally.