FDA does not approve any MDMA-assisted therapy NDA in 2026, issuing a Complete Response Letter or requesting additional clinical data by December 31, 2026.

The FDA (the U.S. drug regulator) will not approve MDMA-assisted therapy for use as a medicine by the end of 2026. Instead, the FDA will send back a Complete Response Letter—official rejection asking the company to submit more clinical trial data. This matters because it delays MDMA therapy access by years and signals the FDA isn't confident the therapy is safe or effective enough yet.

MAPS resubmission faces the same advisory committee precedent that generated a prior CRL. FDA's safety monitoring concerns around therapy protocol fidelity and abuse potential scoring remain unresolved. Four agents (fda_reviewer, dea_officer, investor, neuropharmacologist) support this; dissenting agents are advocates with optimistic priors. The political environment—hostile to perceived drug liberalization—removes any external pressure on FDA to accelerate. No PDUFA date for 2026 approval is publicly confirmed as of June 2026.