In August 2024, the FDA rejected Lykos Therapeutics' application for MDMA-assisted therapy for PTSD, issuing a Complete Response Letter that asked for a new Phase 3 trial rather than additional analysis of existing data. Lykos was spun out of MAPS specifically to handle commercialization; the rejection didn't kill MAPS, but it forced a clear separation. Lykos owns the regulatory and commercial problem. MAPS has refocused on advocacy, education, training, and policy.
What MAPS has been doing
In March 2026, MAPS sent an expert delegation to the UN Commission on Narcotic Drugs in Vienna — their first time back at the CND main session in five years. The delegation included senior researchers, policy experts, and veterans from the US, Europe, Australia, and the Middle East.
Also in March, MAPS launched a video series called "Music Is the Bridge" in partnership with the Shulgin Foundation.
In February, MAPS released a Policy Guidebook — a nonpartisan framework for psychedelic policy reform at state and federal levels, covering decriminalization, regulated medical access, harm reduction, and equitable access.
Also in February, MAPS partnered with Columbia University on a first-of-its-kind study of MDMA-assisted couples therapy.
In September 2025, MAPS named Betty Aldworth and Ismail Lourido Ali as co-executive directors.
The bigger picture
MAPS is doing what organizations do after a major setback: consolidating around what they're actually good at. The infrastructure built over thirty years — training protocols, therapy manuals, a global network of researchers — is still intact and still in use. MAPS's own MDMA-assisted therapy for PTSD hub still describes the treatment as investigational, which is a useful shorthand for the organization's current role: it is maintaining public education, program context, and policy groundwork rather than acting like an approval is already in hand. The FDA rejection didn't close the door on MDMA therapy. It extended the timeline. Lykos is figuring out what a new Phase 3 design looks like. Meanwhile MAPS is making sure the policy environment is ready when that trial eventually reads out.