Issue 3 / Week of 16–22 June 2026

Lead Story

Europe's most advanced psychedelic Phase 3 is staked on the one indication that got harder last week.

The blinded EPIsoDE readout we covered last week did what tighter blinding tends to do to psychedelic trials: it missed. Germany's triple-blind trial, built with an active placebo, could not separate psilocybin from placebo on its primary endpoint in treatment-resistant depression — psychedelics' flagship indication, and the one every commercial programme is chasing. That makes one question the most important in European psychedelic medicine right now: who is carrying TRD all the way through Phase 3, and whether the effect survives a hard look. The trial registries answer it more candidly than the press releases do.

Compass Pathways is carrying it — and is already through the gate everyone else is staring at. Both its pivotal TRD trials of COMP360 psilocybin have hit their primary endpoints — the 2026 readout by −3.8 points on the MADRS (p<0.001), an effect that is statistically clear but clinically modest — and both (NCT05711940, enrolment complete at an actual 572 participants; NCT05624268, an estimated 255) are now ACTIVE_NOT_RECRUITING, with the company in FDA rolling NDA review. The lead trial is US-anchored (of its 116 sites, 62 are American, 45 European, 9 Canadian), but it is the programme whose data Europe reads first, and the one that sets the tone.

Now read what everyone else registered. Cybin's CYB003 (NCT06793397) is RECRUITING — but for major depressive disorder, not TRD: a broader, less battle-scarred population. Compass's own newest Phase 3, the Redefine study (NCT07570654), isn't depression at all — it's PTSD. And AtaiBeckley's BPL-003, the TRD hopeful, still has no Phase 3 record on ClinicalTrials.gov.

The releases all read "Phase 3 on track." The registries reveal the strategy underneath: the field is quietly routing around resistant depression — into broader MDD, into PTSD, into guidance — while Compass, having already cleared the efficacy bar, is the one programme committed to carrying TRD all the way. What to watch is no longer whether COMP360 works on the primary endpoint — it does, modestly — but whether the effect lasts: the 26-week COMP006 durability data, due early Q3, then the NDA decision. That readout lands exactly as EPIsoDE has raised the bar on whether a psilocybin signal in TRD holds up under honest scrutiny. If durability disappoints, the most advanced programme in Europe is also the most exposed.

Context

One name in the lead needs a footnote: AtaiBeckley. As covered in our H1 review, atai and Beckley Psytech combined in November 2025 to form AtaiBeckley Inc. (NASDAQ: ATAI), folding both into a single pipeline — BPL-003 (intranasal 5-MeO-DMT, TRD), EMP-01 (oral R-MDMA, social anxiety) and VLS-01, with cash guided into the early-2029 Phase 3 readouts. The point for this week is narrower than that recap: of the three TRD-and-adjacent contenders above, AtaiBeckley is the only one without a Phase 3 yet on the registry — which is what makes its BPL-003 timeline (see The Call) worth watching.
Source: https://ir.ataibeckley.com/news-releases/news-release-details/ataibeckley-reports-first-quarter-2026-financial-results-and

Signal

Cybin takes CYB003 into Phase 3 with European sites in six countries. Cybin's deuterated psilocin analogue is now recruiting for a Phase 3 trial in major depressive disorder, with sites in Czechia, Germany, Greece, Ireland, Poland and the UK. That an Irish-incorporated sponsor — Cybin IRL Limited — is running a six-country European Phase 3 is the clearest sign yet that Europe has become a primary theatre for late-stage psychedelic development, not a place sponsors bolt on for extra sites.
Source: https://clinicaltrials.gov/study/NCT06793397 (registry updated 11 June)

France lines up a psilocybin Phase 3 in alcohol use disorder. Centre Hospitalier Universitaire de Nîmes has registered a Phase 3 trial, not yet recruiting, testing psilocybin for relapse prevention in alcohol use disorder with depressive symptoms. France keeps building an academic-led psychedelic footprint, and CHU Nîmes is becoming a recurring name on the European trial map — a reminder that the most interesting EU work isn't only coming from listed companies.
Source: https://clinicaltrials.gov/study/NCT07638553 (registry updated 10 June)

Sweden pushes an oral, slow-release ketamine to its Phase 2 readout. A Lund University trial led by Daniel Lindqvist, testing add-on oral slow-release ketamine tablets in major depression, is now active and no longer recruiting. It's a shot at a take-home ketamine format — the form factor that would matter most for access, and the hardest to get right, if it survives Phase 2.
Source: https://clinicaltrials.gov/study/NCT07396272 (registry updated 18 June)

Data Point

Ten — European countries with listed sites in Compass's COMP360 Phase 3 (NCT05711940): Czechia, Denmark, France, Germany, Ireland, the Netherlands, Poland, Spain, Sweden and the UK. What it reveals: a single psychedelic Phase 3 spans ten European jurisdictions' trial, import and controlled-substance handling regimes at once — the operational tax Europe's fragmentation imposes, in one number. The trial is US-anchored overall (of 116 sites, 62 are American, 45 European, 9 Canadian), but Europe is a substantial bloc, not a token presence.
Source: https://clinicaltrials.gov/study/NCT05711940

Regulator Watch

Germany / BfArM: psilocybin compassionate-use pathway — primary source pending; not running until confirmed beyond Psychedelic Alpha's 16 June interview.
EU CTR / EMA: nothing surfaced — but this is a blind spot, not a finding. We have no working EMA feed yet (EMA's site returns antibot errors on every RSS path; flagged in monitor/feeds.txt as needs-another-method). Report as "nothing we can see," not "nothing moved."

The Call

Scoring last issue's call

In Issue 2 I made the call: AtaiBeckley will not announce its first BPL-003 Phase 3 patient dosed before 30 June 2026. I also said, in print, that if a dosed-patient release landed this month I'd mark myself wrong here. So I went and checked.

There is no first-patient-dosed announcement. AtaiBeckley has put out no press release to that effect, and there is still no BPL-003 Phase 3 record on ClinicalTrials.gov — not recruiting, not even registered. The company's most recent guidance (the 10 and 17 March releases, restated in the 12 May Q1 results) says only that Phase 3 "initiation" is "on track for Q2 2026." Initiation is not dosing, and guidance is not a trial.

So the trigger I set for myself hasn't fired. The call stands and resolves on 30 June, when Q2 closes. If a dosing release surfaces in the final week of the quarter I'll mark the miss in Issue 4 — but as of this issue, the bet is good.

This week's call

AtaiBeckley will report its first BPL-003 Phase 3 patient dosed in Q3 2026 — after 30 June, before 30 September. Same logic that's held so far: the Q2 initiation language stays alive to the wire, but the gap between "initiated" and "dosed" spills into the next quarter. Falsifiable, dated, and a clean follow-on to the call above.