TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.
Fourth Quarter Highlights and Significant Milestones
- On October 26, 2023, the Company received a response from the Food and Drug Administration (“FDA”), advising that pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), the orphan-drug designation (“ODD”) request of mesenchymal stem cell (“MSC”) derived small extracellular vesicles (“EVs”) loaded with short and modified interfering RNA (“siRNA”) against the phosphatase and tensin homolog (“PTEN”) protein is granted for treatment of acute Spinal Cord Injury (“SCI”). This achievement is expected to profoundly shape the Company’s regulatory and go-to-market strategies for ExoPTEN. ODD offers substantial benefits, including market exclusivity and protection upon drug approval (in addition to existing IP protection), financial incentives, regulatory assistance, and developmental support. Overall, this designation serves to incentivize and facilitate the development of treatments for rare diseases, thereby enhancing patient access to therapies
- On March 1, 2024, the Company commenced the setup of in-house laboratories and offices to bolster its research and development capabilities, subsequent to entering into lease and construction agreements. Completion of these initiatives is anticipated by the end of June 2024.