2023-10-30 13:16:23 ET
Classification as an %OrphanDrug incentivizes and supports the development of certain treatments, increasing access to therapies for rare diseases and providing significant benefits, including market exclusivity, regulatory assistance and financial incentives.
Pioneering biotechnology company %NurExoneBiologic (TSXV: ) announced in a press release today that the U.S. Food and Drug Administration granted Orphan-Drug Designation (ODD) for its ExoPTEN therapy, a groundbreaking regenerative therapy for acute spinal cord injury, a condition where effective treatments are limited.
The significant development covers the use of mesenchymal stem cell (MSC) derived small extracellular vesicles (EVs) loaded with short and modified interfering RNA (siRNA) targeting the phosphatase and tensin homolog (PTEN) protein for acute spinal cord injury, as implemented in the ExoPTEN drug under development.
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