FDA 483 - Axsome Therapeutics, Inc. - February 06, 2026

An FDA inspection of Axsome Therapeutics, Inc. in New York, NY, revealed significant deficiencies in their oversight of clinical trials. The firm failed to notify the FDA of an investigator's termination for cause and did not ensure studies were conducted according to protocol and monitoring plans. These issues indicate a lack of proper control over clinical trial conduct and documentation.