COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a UK-headquartered clinical-stage biopharmaceutical company and the most advanced developer of a classic psychedelic medicine. Its lead asset, COMP360 — a synthetic, proprietary formulation of psilocybin — is being developed for treatment-resistant depression (TRD) delivered alongside a psychological-support model.
COMP360 is the first psilocybin programme to complete two positive pivotal Phase 3 trials: COMP005 met its primary endpoint in June 2025 and the confirmatory COMP006 (two fixed doses given three weeks apart) did so in February 2026, with 26-week data reported in July 2026 confirming a rapid and durable antidepressant profile. In April 2026 the FDA granted a rolling NDA submission request and selected COMP360 for the Commissioner's National Priority Voucher programme, which carries a shortened review window. COMPASS has since begun that rolling submission and guides to a potential US launch in the first half of 2027, subject to approval, positioning it as the frontrunner for the first FDA-approved classic psychedelic therapy.