Psychedelics at a tipping point: Compass and Definium prepare NDA filings after Lykos setback and upcoming Phase 3 catalysts

Psychedelics drug development is at a potential 2026 tipping point as Compass Pathways and Definium prepare to move from clinical validation toward large scale approval and launch after Lykos’ MDMA program hit regulatory trouble. Compass is planning multiple near term readouts for its psilocybin based treatment COMP360 for treatment resistant depression, including additional Phase 3 data releases tied to trials like COMP005 and COMP006. Definium, previously MindMed, is advancing an LSD based DT120 program with upcoming Phase 3 catalyst readouts for generalized anxiety disorder and major depressive disorder. Analysts frame the moment as a shift from speculation to executable commercialization, while still highlighting likely barriers such as DEA rescheduling after an FDA approval, state level implementation, and post approval requirements like REMS, plus practical issues around clinician capacity and treatment session duration. The piece also notes political and regulatory signals from FDA leadership and the broader reaction to prior Lykos rejection details.