Anavex Life Sciences Receives FDA Clearance to Proceed Ahead With Its Planned Clinical Trial Under Its Investigational New Drug Application For ANAVEX For Fragile X Syndrome

Anavex Life Sciences Corp. ("Anavex" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system diseases with significant unmet medical needs, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the Company may proceed with its planned clinical study under its Investigational New Drug Application (IND) for ANAVEX®2-73 (blarcamesine) for Fragile X syndrome (FXS), a genetic condition that is the most common inherited cause of intellectual disability and developmental delay and the most commonly known single-gene cause of autism, for which no FDA-approved treatment currently exists. The IND is now open, enabling clinical investigation of blarcamesine in FXS in the United States. Blarcamesine has previously received Orphan Drug Designation from the FDA for the treatment of Fragile X syndrome.