San Jose, CA; September 4, 2025 — In August 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD). Today, the FDA made this CRL publicly available for the first time, providing transparency into the agency’s decision-making process. … Continue reading MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy| Multidisciplinary Association for Psychedelic Studies – MAPS
In the wake of the FDA's rejection of its proposed MDMA-assisted therapy for PTSD, Lykos Therapeutics laid off approximately 100 employees and appointed new leadership while the MAPS nonprofit cut 33% of its workforce.| Lucid News - Psychedelics, Consciousness Technology, and the Future of Wellness