Compass Pathways reported a second positive pivotal trial for its synthetic psilocybin candidate COMP‑360, clearing a major regulatory milestone and triggering a fast‑track approval push. The company said two Phase‑3 trials met primary endpoints on depression rating scales; management plans a rolling NDA and expects to engage the FDA on a submission later this year. The data come from the COMP005/COMP006 program and replicate earlier positive results, giving Compass the efficacy package typically needed for a regulatory filing. Analysts and clinicians cited by company releases and coverage (COMPASS statements, STAT/press reports) say the twin Phase‑3 successes materially improve the drug’s approval odds but emphasize the need for full datasets to assess durability, safety, and clinical meaningfulness. Compass’s shares reacted strongly to the news, reflecting investor recalibration of commercialization timelines and market access scenarios. COMP‑360 is a synthetic psilocybin formulation intended for treatment‑resistant depression; the therapy’s mechanism relies on psychedelic‑assisted therapy protocols paired with a single‑dose pharmacologic intervention. If approved, COMP‑360 would be among the first classic psychedelics to reach U.S. market authorization, requiring new delivery and reimbursement frameworks for clinic‑based administration.