Compass Pathways COMP360 FDA Priority Review

Oregon crossed a threshold that would have seemed unthinkable five years ago: the state now has more than 100 licensed psilocybin service centers operating under Measure 109, the 2020 ballot initiative that created a legal, supervised access framework for psilocybin therapy. The centers are distinct from dispensaries — they require a licensed facilitator, a preparation session, the supervised experience itself, and a follow-up integration session. Clients don’t take the product home. The model is clinical, not recreational.

In Colorado, June 1, 2026 marked a key regulatory deadline for the state’s advisory board on natural medicine. Colorado’s Proposition 122, passed in 2022, decriminalized personal possession and non-commercial cultivation of psilocybin, psilocin, DMT, ibogaine, and mescaline — a broader psychedelic decriminalization than Oregon’s measure. The June 1 deadline related to potential regulatory inclusion of DMT and mescaline in the state’s supervised healing center framework, adding those compounds to psilocybin as available options for licensed facilitation.

These are state-level developments. Federally, psilocybin and related compounds remain Schedule I substances, and that gap — between what states permit and what federal law says — creates significant complications: no interstate commerce, no federal reimbursement, no insurance coverage, and ongoing ambiguity for practitioners operating across state lines.

What makes the current moment different from earlier cycles of psychedelic policy interest is the parallel movement at the federal level. Compass Pathways has targeted Q4 2026 for its rolling NDA submission to the FDA for COMP360, its synthetic psilocybin compound, for treatment-resistant depression — with Phase III data that met its primary endpoint in June 2025. A Trump administration executive order in April 2026 directed federal agencies to expedite research on psychedelic medicines. And 22 states are actively tracking psychedelic medicine legislation, with Arizona among those considering frameworks.

For treatment providers and case managers, the near-term clinical reality is: psilocybin therapy is available in Oregon now, legally, at scale. For clients who have exhausted other options for treatment-resistant depression, PTSD, or alcohol use disorder — the conditions with the strongest current evidence base — Oregon’s framework represents a viable, if expensive and logistically complex, option. What doesn’t exist yet is any reimbursement pathway, any standard of care, or any clear answer to what comes after the facilitated session ends. Those gaps are the clinical frontier. The legal framework is no longer the constraint.

The 22 states watching Oregon are watching it learn those lessons in real time.