Lykos Therapeutics' FDA approval application for MDMA capsules, MDMA-AT, to treat PTSD was rejected by a US panel on June 4, 2024.

The rejection was due to concerns from FDA reviewers about safety, evidence inconsistencies, and trial design.

This decision affects the future of psychedelic therapy for mental health issues.

Researchers remain optimistic about MDMA's potential to reduce PTSD symptoms by calming fear and anxiety responses in the brain.

The FDA's final decision is expected by August 11, which may include strict usage limits like certified doctors and therapists prescribing and administering the drug.

Financial investments in the psychedelic industry could be affected by the FDA's ruling on MDMA.

Clinicians, such as Dr. Rachel Dalthorp, continue to see promise in psychedelics for treating PTSD.

If approved, MDMA would be reclassified as a prescription medication, offering hope for patients and families.