Technology thesis · Biotechnology & Health
low conviction emergingPsychedelic medicine
Compass COMP360 has now cleared two positive psilocybin Phase 3 trials; the open questions are FDA filing, delivery-model economics and DEA rescheduling, not efficacy.
Position maintained continuously · last reviewed Jun 24, 2026
The thesis
Compass COMP360 has cleared both pivotal trials; the contest is now commercialisation
Compass COMP360 psilocybin met its primary endpoint in both Phase 3 TRD trials – COMP005 (single 25mg dose, 2025) and COMP006 (25mg vs 1mg, –3.8 points, p<0.001, February 2026). Compass is running a rolling NDA submission with sections already filed and the final submission guided for Q4 2026. The bellwether question has flipped from whether psilocybin works to whether a REMS-heavy, in-clinic dosing model can be reimbursed and scaled.
Definium (ex-MindMed) LSD and GH Research 5-MeO-DMT are the second wave
MindMed rebranded to Definium Therapeutics (Nasdaq DFTX) in January 2026, with MM120 LSD now DT120. Its Phase 3 Emerge study in MDD posted positive topline data in June 2026; the GAD studies Voyage (H1 2026) and Panorama (H2 2026) are the remaining LSD readouts. GH Research had its GH001 (inhaled 5-MeO-DMT) clinical hold lifted in January 2026 after a –15.5-point MADRS Phase 2b result, and is only now initiating global Phase 3 – so its pivotal data sits beyond the LSD and psilocybin reads.
State decriminalisation provides a narrow, non-FDA pathway
Oregon Measure 109 and Colorado Proposition 122 remain the only state-regulated adult psilocybin-service frameworks live in 2026. Massachusetts Question 4 failed at the ballot in November 2024 (56-43), so the much-cited multi-state wave has stalled. This is a parallel channel for supervised access, but it cannot scale within the US federal framework without FDA approval and DEA rescheduling – it does not substitute for the clinical pathway.
State of the art (2026)
The category has flipped from binary clinical risk to commercialisation risk. Compass Pathways’ COMP360 psilocybin met its primary endpoint in both pivotal Phase 3 trials – COMP005 in 2025 and COMP006 in 2026 (25mg vs 1mg, −3.8 points, p<0.001) – and Compass is guiding to a US NDA filing in Q4 2026. GH Research’s inhaled 5-MeO-DMT (GH001) posted a −15.5-point placebo-adjusted MADRS Phase 2b result, and MindMed’s MM120 LSD has Phase 3 Voyage (H1 2026) and Panorama (H2 2026) GAD readouts pending. Lykos remains the laggard – the FDA wants a fresh third MDMA Phase 3 after the August 2024 CRL. The unresolved bottlenecks are DEA Schedule I→III rescheduling, REMS-heavy clinic delivery and payer reimbursement.
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Signal stack
Evidence stacked leading → lagging
Technology-native KPIs
Metrics that predict trajectory, tracked over time
Landscape map
Who builds what — and who depends on whom
Catalyst calendar
Dated events that will move the position
Technology roadmap
Milestones on the path to maturity
Watchlists
Companies, people and papers — each with a remove-by condition
Decision frameworks
The same call, framed for your desk
Thesis changelog
When our view changed, and why
Change our mind
5 disconfirming conditions
The rest is inside
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