companyBiotechnology / Psychedelic-Assisted TherapeuticsUnited States

MAPS PBC

Clinical-stage public benefit corporation developing MDMA-assisted therapy for PTSD, subsidiary of the non-profit MAPS

MAPS PBC (MAPS Public Benefit Corporation) was established in 2014 and is headquartered in San Jose, California. It operates as a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization, and carries a dual mandate to generate shareholder value while advancing public benefit. As a Public Benefit Corporation, it was purpose-built to translate MAPS' decades of psychedelic research into clinically approved medicines.

The company's primary focus has been the development of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The FDA designated this therapy as a Breakthrough Therapy, and in December 2023, MAPS PBC submitted the first-ever New Drug Application (NDA) for a psychedelic-assisted therapy — drawing on over 30 years of clinical research and two Phase 3 trials (MAPP1 and MAPP2) that met both primary and secondary endpoints.

MAPS PBC subsequently rebranded as Lykos Therapeutics, coinciding with a $100 million oversubscribed Series A financing round. However, in August 2024, the FDA issued a Complete Response Letter rejecting the NDA for MDMA-assisted therapy, and within days Lykos Therapeutics announced layoffs of approximately 75% of its staff.

The entity is directly relevant to innovations in psychedelic-assisted mental health treatment, regulatory strategy for novel therapeutics, and the intersection of non-profit research missions with for-profit clinical development structures.

Ideas that could help MAPS PBC

MDMA-Assisted PTSD Therapy Deployment Clinic Network
A network of licensed outpatient clinics ready to administer the phase-3-validated MDMA-assisted manualized therapy protocol for severe PTSD, targeting high-need populations such as veterans, first responders, and survivors of childhood trauma.
Why it helps: MAPS is sponsoring FDA approval and needs licensed clinic partners to commercialize MDMA-assisted therapy at scale; a credentialed clinic network is the primary deployment vehicle for their product.