04:50 PM EST, 11/13/2024 (MT Newswires) -- NurExone Biologic ( NRXBF ) on Wednesday said the European Medicines Agency (EMA) granted Orphan Medicinal Product Designation for the company's ExoPTEN therapy, a potential treatment for acute spinal cord injury patients across Europe.
Designed to provide nerve regeneration and functional recovery following spinal cord injury, ExoPTEN uses mesenchymal stem cell-derived extracellular vesicles loaded with siRNA targeting PTEN, a key protein in nerve regeneration.
According to the statement, the EMA's Orphan Medicinal Product Designation offers valuable incentives, including 10 years of market exclusivity upon approval and access to grants and incentives from the European Commission and Member States. NurExone may also benefit from free or lower cost scientific advice and assistance with clinical trial design, which can streamline the regulatory process and reduce development costs. Some European Union countries also provide tax credits and other financial incentives to support orphan drug development.
The company's shares closed up $0.03 to $0.63 on the TSX Venture Exchange.