The US FDA has rejected Lykos Therapeutics' request to approve MDMA (also known as ecstasy or Molly) as a treatment for post-traumatic stress disorder (PTSD). The decision follows an FDA advisory panel's conclusion that there wasn't enough evidence to recommend approval. Despite positive clinical trial results showing significant symptom reduction, the agency requested additional Phase 3 trials to further study safety and efficacy. Lykos plans to request a meeting with the FDA to discuss concerns and potential future studies.

Source: https://www.wired.com/story/fda-rejects-mdma-ptsd-treatment/