Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360 and is advancing toward regulatory filing. The company said both Phase 3 studies met their primary endpoints on depression scales, with effects durable through key follow‑up windows. Compass plans a rolling NDA submission later this year and has breakthrough therapy designation for COMP‑360. The twin wins consolidate Compass’s clinical package: the COMP006 readout reached statistical significance at the pre‑specified six‑week primary endpoint, while an earlier pivotal, COMP005, showed sustained effect to 26 weeks. Company statements and market moves following the releases underscore that Compass will engage the FDA on a potential approval pathway. Clinicians and analysts note the data meet regulatory thresholds but stop short of declaring a transformative benefit; further granular safety and subgroup data will be critical for label negotiations. Compass’s regulatory timetable centers on a rolling dossier to the FDA in the fourth quarter, positioning COMP‑360 as a candidate to become the first classic psychedelic cleared for treatment‑resistant depression.