This is the first issue. The deal, briefly: every Tuesday, I cover what actually moved in European psychedelic medicine, the trials, the regulators, the money, and what it means. Not what trended. What moved.

This week looked thin on the surface: no approvals, no financings, nothing from the EMA. But three things happened that matter more than the attention they drew, because most of the attention went elsewhere, to a US approval race that is louder than it is European.

On 2 June, The Lancet Regional Health – Europe published a retrospective study of 19 patients treated with psilocybin for treatment-resistant depression at the Psychiatric University Hospital in Zurich (Jungwirth et al.). These were real patients treated under Switzerland's exceptional-licence route, not trial subjects. Clinician-rated depression scores on the MADRS fell from around 31 to around 20 within 42 days of the final dosing session, across one to four sessions of 20 to 35 milligrams.

It is one of the first peer-reviewed looks at real-world outcomes from a European access route, and that is why it leads. Almost everything we know about psilocybin for depression comes from controlled trials. Europe has quietly been running a different experiment. Switzerland has allowed limited medical use since 2014, Germany opened compassionate access in 2025, and the model is access first, data later. This is an early read on what that model produces.

The read is broadly consistent with what the controlled trials have seen. A change of that magnitude on the MADRS is usually considered clinically meaningful.

Now, the part most coverage will skip. This is a retrospective study of 19 patients, with no control arm and no placebo. These were people who went looking for the treatment, and in depression, expectation bends outcomes. So it is a signal, not proof. It tells us the Swiss route is producing the kind of results the trials promised, in the messier conditions of real practice. It does not tell us the drug did it on its own. Hold it loosely. But real-world European data is exactly what this field has lacked, and now there is some.

On 8 June, Filament Health, now a subsidiary of Red Light Holland, agreed to supply its GMP botanical psilocybin, PEX010, to GHU Paris Psychiatrie & Neurosciences for a study called KETAPSYCHECOG: a randomised, double-blind, crossover trial comparing ketamine and psilocybin in healthy volunteers.

The study is not the story. It is mechanistic work in healthy people, which tells us how these drugs act on the brain and nothing about whether they treat anyone. The story is the address. By its own description, GHU Paris is the largest mental-health hospital system in the capital, serving roughly one in 40 Parisians. France has barely featured on the European psychedelic trial map. A public hospital of that size taking on a regulated psilocybin trial is the kind of infrastructure that tends to come before clinical progress, not after it.

There is a quieter pattern underneath. PEX010 is the same drug product used in Germany's compassionate-use programme and in UK trials. Now France. Access in Europe is fragmented country by country, but the supply layer beneath it is consolidating around a handful of GMP producers. When you cannot yet bet on which country approves first, the picks-and-shovels layer is often the more legible place to look.

On 4 June, Dublin-based GH Research published full Phase 2a results for GH001, its inhaled form of mebufotenin (5-MeO-DMT), in postpartum depression, in The Journal of Clinical Psychiatry. In an open-label trial of 10 women, MADRS scores fell by a mean of 35.4 points by Day 8, with all ten in remission. The company also lands two talks on its Phase 2b treatment-resistant depression data at the CINP congress in Glasgow later this month.

Read it for what it is: ten patients, open-label, no control, and postpartum depression rather than the treatment-resistant indication that drives this field's value. Numbers that large in a sample that small ask for caution, not a headline. But two things make it worth your attention. GH Research is one of the few European-headquartered companies near the front of the drug-development race, and GH001 puts it in direct competition with AtaiBeckley's BPL-003 in the 5-MeO-DMT lane. The drug that reaches market first in that class will set the template. This was a real step, by a European company, in that race.

Compass Pathways has indicated that the 26-week data from its COMP006 Phase 3 trial will arrive in early Q3 2026, with its rolling NDA to the FDA for COMP360 psilocybin targeted for completion in Q4. That is the company's own timing, restated in its Q1 results last month and echoed by analysts this week. So the schedule is company-guided. What is not yet known is the result. I will report the timeline, because the company stands behind it. I will not pretend to know what the data says before it exists.

The European angle, briefly. This is a US filing, but it does not stay in the US. A Compass approval would reshape reimbursement and pricing arguments across Europe long before the EMA has ruled on anything. The bellwether is American. The consequences are not.

A quiet week is information too, so here is what I looked at and did not find moving.

I found no psychedelic-specific announcements from the EMA, the MHRA, or Germany's BfArM this week; their published activity was unrelated to the field. I did not find a fresh clinical release from AtaiBeckley on BPL-003 either; the only item was routine investor-conference attendance, which I am not going to dress up as news.

That is the discipline. I would rather tell you a week was quiet than dress it up.

If something here is wrong, tell me, and I will correct it in the open.

Thank you so much for reading.

Dhruv

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