On Dec. 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) announced their submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine) in combination with psychotherapy for the treatment of post-traumatic stress disorder (PTSD). (Press Release, Lykos Therapeutics, “MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD” (Dec. 12, 2023). This marks the first NDA submission for any psychedelic-assisted therapy and is a major milestone for the medicinal psychedelics industry.

Subsequently, on Jan. 5, 2024, MAPS PBC announced a name change/rebranding to Lykos Therapeutics, as well as the successful close of an oversubscribed Series A financing of over $100 million, which will help fund the regulatory approval and pre-launch steps for MDMA-assisted therapy for PTSD. (Press Release, Lykos Therapeutics, “MAPS Welcomes New Investors, Name Change for MAPS Public Benefit Corporation” (Jan. 5, 2024).