Lykos Therapeutics was spun out of MAPS to handle commercialization of MDMA-assisted therapy for PTSD. In June 2024, an FDA Advisory Committee voted against recommending approval. In August 2024, the FDA issued a Complete Response Letter requiring a new Phase 3 trial rather than reanalysis of existing data.
In March 2026, the journal Psychopharmacology retracted three papers based on Lykos trial data, citing undisclosed competing interests and unethical conduct at a Canadian study site. Lykos disputed the decision.
No timeline has been announced for the new Phase 3 trial.