Issues
Every issue we have published, newest first, with the call each one made.
BPL-003 is the cheapest promise in Lilly's contract.OpenBy 30 June 2027 no new BPL-003 trial is registered on ClinicalTrials.gov or CTIS.
Europe is in the trial Helus hasn't dated.OpenOn 31 March 2027 the primary completion date on NCT06793397 is still 7 June 2027.
Initiated in Q2. Unregistered at the end of Q3.OpenCompass discloses completion of its rolling NDA submission for COMP360, the FDA marketing application, on or before 31 December 2026.
The CVR is an option, and Lilly holds itOpenNo Lilly-sponsored Phase 3 trial of VLS-01 in major depressive disorder is registered on ClinicalTrials.gov or CTIS by 30 June 2027. Our read of CVR Section 4.3(a)(i), the VLS Indication Exclusion, which leaves Lilly no efforts obligation for MDD or GAD.
Five countries, one regulator.OpenLilly does not name BPL-003, VLS-01 or mebufotenin in its Q3 2026 earnings press release, earnings deck, prepared remarks or Q&A, as published on the day of the release. Our read of whether the acquired compounds are a pipeline priority to Lilly's shareholders.
Three authorised, one counted.OpenNone of Slagelse DANP-RCT, Chieti psilocybin plus trazodone, or Amsterdam UMC adolescent PTSD has a ClinicalTrials.gov record by 31 December 2026. Falsifier: any one appears. Scored in the first January issue.
Lilly’s depression trial went from one approval to four in seven days.OpenBefore 31 December 2026, at least one additional EU member state will appear across Lilly's five brenipatide CTIS trials, beyond the current five (Belgium, Germany, Greece, Poland, Spain). Our read that a trial engine that added four national approvals in seven days keeps expanding.
Lilly has five authorised trials in the EU system. None of them are the drugs it just bought.OpenBefore 31 December 2026 the ClinicalTrials.gov record for NCT07775300 (Lilly, brenipatide, Phase 3 MDD) will show overall status RECRUITING AND still carry at least one of Germany, Greece, Poland, Spain or the United Kingdom in its location list. Our read of whether the EU-member site list is real intent or paperwork.
A clinician, not a company, runs Germany's psilocybin compassionate use programmeOpenNo pharmaceutical company will be named as the responsible party on a BfArM compassionate use entry for psilocybin or MDMA before 31 December 2027. Our read, not anyone's stated plan.
No European application on file for the world's most advanced psilocybin programmeOpenCompass Pathways will NOT publicly disclose a marketing authorisation application to the MHRA or the EMA for COMP360 before 30 June 2027 — the end of its own guided US launch window. Our read, not Compass's stated plan; the company has said nothing about future European intent in either direction.
Europe already pays for clinic-administered psychiatry. Just not for psychedelics.OpenNo psilocybin or MDMA therapy will enter a formal health technology assessment or benefit assessment process in Germany, the Netherlands or the United Kingdom before 31 December 2027. Our read, not anyone's stated plan.
Eli Lilly buys AtaiBeckley for $3.8B, and prices Europe out of psychedelic medicineOpenWithin 12 months of the Lilly/AtaiBeckley deal closing, neither BPL-003 nor VLS-01 will have a registered Phase 3 trial carrying ANY EU-member-state site, AND Lilly will have disclosed no EMA pathway for either drug. Our read of the deal's incentives, not Lilly's stated plan.
Compass just put a date on the first Western psychedelic launch: the first half of 2027.OpenCOMP360 (Compass psilocybin) will NOT be commercially available to prescribe in the US by 30 June 2027 — i.e. the guided "first half of 2027" launch slips.
European psychedelic depression development just split into two camps.OpenAtaiBeckley's BPL-003 Phase 3 program, when it registers, will use an ADJUNCTIVE design (patients stay on a stable SSRI, no antidepressant washout mandated). BPL-003 commits to the adjunctive camp, not the washout camp (Compass/EPIsoDE).
LSD just posted the biggest depression number in psychedelic Phase 3 history.HITDefinium's Panorama (Phase 3 GAD, DT120 100µg, with 50µg low-dose unblinding-control arm + EU sites) will show a SMALLER placebo-adjusted effect than its sister trial Voyage (same indication/scale, no low-dose arm). Tests whether the Emerge headline is drug or expectancy.
Europe's most advanced psychedelic Phase 3 is staked on the one indication that got harder last week.MISSAtaiBeckley will report first BPL-003 Phase 3 patient dosed in Q3 2026 (after 30 June, before 30 September).
Blind the psilocybin trials in TRD, and the effect shrinksHITAtaiBeckley will NOT announce first BPL-003 Phase 3 patient dosed before 30 June 2026. Expects initiation language near the wire; confirmed dosing slips to Q3.
Psychedelic BriefNo call made — "The Call" section not yet established in this issue.