"The #FDA and its advisors identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of #psychedelics. #Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (#MAPS)."
https://arstechnica.com/science/2024/08/mdma-for-ptsd-three-studies-retracted-on-heels-of-fda-rejection/
MDMA for PTSD: Three studies retracted on heels of FDA rejection

The company behind the therapy says it will appeal the FDA's decision.

Ars Technica