SIOX - Sio Gene shares rise after FDA Fast Track status for AXO-AAV-GM2 gene therapy

The U.S. FDA has granted a Fast Track Designation to Sio Gene Therapies' (NASDAQ:SIOX) AXO-AAV-GM2, an investigational gene therapy for the treatment of early infantile, late infantile, and juvenile-onset Tay-Sachs and Sandhoff disease. Shares up more than 5% premarket. The Fast Track status is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track status is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. Tay-Sachs and Sandhoff diseases, also known as GM2 gangliosidosis, is a set of rare and fatal pediatric neurodegenerative genetic disorders.

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Sio Gene shares rise after FDA Fast Track status for AXO-AAV-GM2 gene therapy