On December 11, 2023, following positive results from two published Phase 3 studies, MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the Federal Drug Administration (FDA) for an investigational MDMA-assisted therapy for persons suffering from post-traumatic stress disorder (PTSD).
After submitting its NDA on January 5, MAPS PBC announced it would be changing its name to Lykos Therapeutics (Lykos). This was after the close of a round of Series A financing in which MAPS PBC raised north of $100 million dollars. At the forefront of this round of financing was celebrity-backed global problem-solving organization, Helena, which touts members such as physician and holistic wellness guru Deepak Chopra.
Lykos has stated it believes Helena is the right partner to help position Lykos in its transition from a research-focused public benefit company (wholly owned by the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS)) to a public-benefit company with mission-aligned investors focused on obtaining FDA approval and insurance coverage for prescription use of MDMA-assisted therapy by appropriate patients with PTSD.
The FDA has 60 days from Lykos’s submission to determine whether the NDA will be accepted for review. If accepted, the FDA’s approval decision could come as soon as August 2024. If approved, Lykos’s MDMA capsule would be the first legally approved MDMA-assisted therapy approved in the United States.
Lykos is wasting no time while waiting for its FDA approval. According to the press release from the company, Lykos is moving ahead with its plans to build commercial capabilities to integrate its planned MDMA-assisted therapy into the health care system. MAPS has also stated it will continue its non-profit work and focus on humanitarian research with MDMA around the world in areas with a high prevalence of trauma and few resources.
To learn more about the information contained in this client alert or the potential implications of an approval for the psychedelic industry as a whole, please contact the authors.