FDA 483 - Lykos Therapeutics, Inc. - May 15, 2024

An FDA inspection of Lykos Therapeutics, Inc. in Santa Cruz, CA, from April 29 to May 15, 2024, revealed significant issues with clinical trial conduct. The firm failed to ensure investigators had accurate information and adhered to study protocols, specifically noting inconsistencies in adverse event definitions and the improper use of digital copies instead of primary source documents for critical data reporting.