BREAKING: Second Positive Phase 3 for Compass’ Psilocybin, Though Modest Magnitude Raises Questions
Psychedelic Alpha ↗
To dive deeper into the topline readout, we spoke to Compass CEO Kabir Nath and Chief Medical Officer Guy Goodwin.
Explore our 🎯 Q1 2026 Psychedelic Pipeline Bullseye Charts.
Compass Pathways’ Phase 3 readout dominated this week’s new cycle, as the company shared topline data from the psilocybin for treatment-resistant depression program on Tuesday morning.
It certainly kept us busy! Early on Tuesday morning, we published our analysis of the news, which included discussion with Compass CEO Kabir Nath and CMO Guy Goodwin. Later in the day, we shared our notes from the company’s webcast, during which further data was shared. And, on Friday, we published views from across the field, synthesising what we had heard from researchers, practitioners, and executives.
Elsewhere, two psychedelics trials were published in academic journals this week, providing a more detailed look at methods and outcomes. On Monday, a Phase 2a trial of intravenous DMT for major depressive disorder, carried out by Small Pharma (which has since been acquired by Helus), published in Nature Medicine. Then, on Wednesday, Transcend Therapeutics’ Phase 2 trial of methylone for PTSD published in JAMA Psychiatry.
On Thursday, we shared the latest edition of our Psychedelic Drug Development Pipeline Bullseye Charts, supported by UBC. These visualisations aim to provide a one-stop overview of the pipeline, from discovery through to approval, segmented by molecule and indication.
While our Bullseye Charts show an increase in late-stage trial activity, earlier this week, FDA’s Vinay Prasad and Martin Makary appeared to confirm the agency’s intent to expect just one pivotal trial by default, via a letter in NEJM. We dive deeper in our next Bulletin.
For the next two weeks, Psychedelic Alpha is on the road. I will be speaking at the 6th Annual Psychedelic Therapeutics & Drug Development Conference in New Orleans on Thursday, as well as at an event at the New Orleans BioInnovation Center. I then head to New York and Washington, D.C. If you would like to connect, please do get in touch.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.
Josh Hardman
Founder & Editor
BREAKING: Second Positive Phase 3 for Compass’ Psilocybin, Though Modest Magnitude Raises Questions
To dive deeper into the topline readout, we spoke to Compass CEO Kabir Nath and Chief Medical Officer Guy Goodwin.
This week, we published the third Issue of The Psychedelic Practitioner, which focuses on psychedelic dosing sessions or ceremonies. In it, you will hear from practitioners, ethicists, and researchers, who complement our regular programming of practitioner-relevant news and research updates.
Elsewhere, the Oregon Psychedelic Evaluation Nexus (OPEN) announced that it has scored a five-year $3.3 million grant from the National Institute of Drug Abuse (NIDA) to measure the impact of state-legal psychedelic services. It is the first grant of its kind.
Early on in the week, Helus Pharma (formerly Cybin) announced the appointment of a new CEO, Michael Cola, whom we briefly interviewed.
Next week, we launch our Q1 2026 psychedelic pipeline Bullseye Charts, so do keep an eye on your inbox and our socials.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.
Josh Hardman
Founder & Editor
This week, it became public knowledge that the Trump administration last October vetoed a Commissioner’s National Priority Voucher (CNPV) that FDA had apparently hoped to award to psilocybin drug developer Compass Pathways. STAT broke the story.
As I noted on LinkedIn, the episode appears to be further evidence that MAGA and MAHA remain misaligned on several fronts, with the administration perhaps wary of the optics of accelerating the review of a psychedelic drug further, particularly as the midterms approach.
In our view, the snub is unlikely to materially alter Compass’ timeline. The CNPV aims to cut the review time down to one or two months, the agency has said, but Compass already benefits from numerous regulatory tailwinds, including breakthrough therapy designation and rolling review (it announced the latter last November, when it said it was accelerating its launch timeline by up to a year).
So, there is little reason to believe that FDA’s Division of Psychiatry is resting on its laurels, here. And just as the administration may be sensitive to optics ahead of the midterms, the psychedelic drug development field is wise to be mindful of optics, too. A psychedelic new drug application should (be seen to) succeed on its own merits, with scientific rigour and throgouh review likely to confer greater long-term credibility than the risk of a CNPV review appearing rushed or politicised, particularly as that program becomes increasingly controversial.
Elsewhere, psychedelics featured prominently in the mainstream media this week. The Guardian reported on calls from a former British Army chief for MDMA-assisted therapy to be made available to UK veterans, while Michael Pollan’s new book on consciousness has generated fresh media attention, including a feature interview with The New York Times.
Elsewhere, in our latest Bulletin, we share some observations and updates on America’s psychedelic drug du jour: ibogaine. We also take a closer look at the aforementioned CNPV snub, a Delaware lawsuit that sees Signant Health accuse Definium Therapeutics of trade secret theft, a roundup of the latest psychedelics-related Bills, and much more.
We also covered the latest data from Oregon’s psilocybin system and published an interview with Bruce Damer of the Center for MINDS.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.
Josh Hardman
Founder & Editor
Psychedelic Bulletin 219
This week gave us a chance to catch our breaths following a flurry of developments and headlines in the first few weeks of 2026.
Still, there is plenty to review on the psychedelic policy reform front, with psychedelics-related bills introduced or revived in state legislatures across the U.S. At present, our Psychedelic Bill Tracker is tracking 75 bills, and this week we published our January round-up.
There’s activity at the federal level, too, with a new House bill introduced this week that aims to establish a psychedelics research and extended/compassionate access program in the VA.
Here at Psychedelic Alpha, we published an interview with Joost Breeksema on the ‘human side’ of psychedelic therapy, an Op-Ed on psychedelic public health, and our 2026 Psychedelic Alpha Reader Survey.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.
Josh Hardman
Founder & Editor
Free subscribers receive a weekly round-up of news on psychedelics, as well as the occasional article.
Receive regular bulletins, articles, interviews with insiders and quick-take analysis of major stories and developments.
Teams, groups and corporate pricing plans are available, please get in touch via email to learn more.
Front-row access to the psychedelics space: breaking bulletins, in-depth articles, insider interviews and sharp analysis of the moments that matter—from major trial results and funding rounds to policy shifts shaping the future. Plus, full access to our complete archive and Library.
Learn More| Free | ||
|---|---|---|
| Weekly Psychedelic News Feed | ||
| Occasional Articles & Free Resources | ||
| Psychedelic Bulletins (In-Depth Briefings, Multiple per Month) | ||
| Quick-Take Analysis of Major Developments | ||
| In-Depth Articles & Deep Dives | ||
| Exclusive Interviews with Insiders & KOLs | ||
| Quarterly Video Briefings | ||
| Exclusive Tools & Data Resources | ||
| Library of Primers & Explainers | ||
|
Subscribe Now |
||
Independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and research.
By signing up, you agree to our privacy policy. You can unsubscribe at any time.
Aside from group pricing, we also offer bespoke reports and regular briefings. Get in touch to discuss.