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March 9 – 15, 2026

A Note from the Editor

As you may have noticed, we’re celebrating six years of Psychedelic Alpha with a brand new website and look. As part of that revamp, emails are looking slightly different, too, including your weekly Psychedelic News Feed. Rest assured, the format remains the same: a weekly digest of psychedelics-related coverage from around the world.

At the start of this week, we reported on talks that AtaiBeckley is in with potential pharma partners and royalty investors. Those discussions revolve around its lead candidate, intranasal 5-MeO-DMT (BPL-003) for treatment-resistant depression, which is expected to enter Phase 3 in the second quarter. Sources close to the company told us that it does not intend to sell the asset outright, and hopes to use any fresh capital to explore the drug in other conditions, as well as to progress other candidates in its pipeline.

Later in the week, our 221st Psychedelic Bulletin took a closer look at recent readouts and publications, including Johnson et al.’s psilocybin vs. nicotine patch for smoking cessation study, which published this week. It reports that, at the 6-month follow-up, 40.5% (n=17/42) of those in the psilocybin group achieved prolonged abstinence versus 10% (n=4/40) in the nicotine patch arm.

Elsewhere, UW-Madison’s School of Pharmacy announced a new professorship in psychedelic science, which it describes as “the second of its kind in the United States and the first in a pharmacy school.” Professor Paul Hutson, who led the first Phase I psilocybin trial in the country, is the inaugural recipient.

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

March 2 – 8, 2026

A Note from the Editor

There are now around one-hundred psychedelics-related bills in-flight across the U.S., at the state and federal level. Many are making slow progress through their respective legislatures, but others have begun to pass chambers and make it to the desks of Governors. This week, we shared our February 2026 roundup, which provides a one-stop view of new bills introduced last month as well as those that have made substantial progress.

Elsewhere, Bloomberg reported yesterday that AtaiBeckley is exploring partnership or sale options for BPL-003 (intranasal 5-MeO-DMT), its lead candidate that is currently under development for treatment-resistant depression. We will be sharing more on this front next week.

For my part, I have been in New York, Baltimore, and Washington, D.C., this past week, speaking with psychedelic researchers, investors, drug developers, and regulators. Keep an eye out for our next Bulletin to read what I gleaned on this trip.

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

February 23 – March 1, 2026

A Note from the Editor

I had a great time in New Orleans this week, where I delivered a ‘State of the Psychedelic Industry’ at the Psychedelic Therapeutics and Drug Development Conference and participated in a panel on ‘psychedelic innovation’ at the New Orleans BioInnovation Center.

I’m now in Austin, Texas, where U.S. Health and Human Services (HHS) Secretary RFK Jr. appeared on the Joe Rogan Experience for a two-and-a-half-hour discussion that included around ten minutes on the topic of psychedelics.

“I would say everyone at my agency, as well as over at VA, at Doug Collins’ agency, is very anxious to get a rule out there that will allow these kinds of studies, will allow access in therapeutic settings,” he told Rogan. But Kennedy was broadly noncommittal when discussing how access to psychedelics might manifest in the U.S. medical system.

The Secretary emphasised a need for guidelines to prevent a “Wild West” that could result in “horror stories”. “Some people can have very, very bad experiences on [psychedelics]”, he told Rogan. “We need to move in baby steps with this, because you don’t wanna create a situation where people are getting hurt”, he went on.

He also reiterated his personal interest in the class of drugs, including ibogaine. “I have seen so much overwhelming anecdotal evidence, but also clinical studies, that attest to the effect of this under some circumstances with some people for these medicines”, he told Rogan.

The comments come around eight months after RFK Jr. told Congress that the administration was working to ensure access to psychedelics within a year, though the Secretary appears more restrained than when he made that vow. A more detailed write-up of RFK Jr.’s comments will appear in our next Bulletin.

Elsewhere this week, AtaiBeckley shared a topline readout from its Phase 2a R-MDMA (EMP-01) for social anxiety disorder trial. While the company described the readout as positive, pointing to safety and tolerability findings, shares in the company dropped on the news. Future development plans for the candidate are unclear at present.

Also on the psychedelic drug development front, Reunion Neuroscience shared that FDA has granted its lead candidate, RE104 (4-HO-DiPT), breakthrough therapy designation for postpartum depression.

Here at Psychedelic Alpha, we covered further news stories from the past week in Bulletin 220, including new survey data from RAND that found Americans are divided on psychedelics policy, with 23% open to psilocybin use being legalised.

We also published a discussion I had with Yale’s Dr. Terence Ching about learnings from Yale’s psilocybin for OCD trials.

I’m now heading to New York and Washington, D.C.

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 220

Psychedelic Alpha ↗

  • Policy Round-Up: State Momentum, Congressional Signals, and Colorado’s Data Build-Out
  • RAND Survey: Americans Divided on Psilocybin Legalisation
  • New Publications: DMT, Methylone, and Germany’s State-Funded Psilocybin Trial
  • Latest Data from Australia Reports 188 Patients Treated
  • FDA’s ‘One Pivotal Trial’ Default
  • and more…

February 16 – 22, 2026

A Note from the Editor

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

Febraury 09 – 15, 2026

A Note from the Editor

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

February 02 – 08, 2026

A Note from the 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: Trump Admin. Vetoed Compass Priority Voucher; Ibogaine in Focus; Definium Sued by Former Vendor; Psychedelics Feature in Epstein Files

Psychedelic Bulletin 219

Psychedelic Alpha ↗

  • Trump Administration Vetoed Compass Priority Voucher
  • Ibogaine in Focus
  • Definium Sued by Former Vendor Over Alleged Trade Secret Theft
  • Psychedelics Surface in Newly Released Epstein Documents
  • Fresh State Bills Add to Growing Psychedelics Docket
  • and more…

January 26 – Febraury 1, 2026

A Note from the Editor

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

January 19-25, 2026

A Note from the Editor

The biggest headline in the psychedelics field this week was outgoing New Jersey Governor Phil Murphy’s signing S2283 into law, establishing a $6M psilocybin pilot program in the state. While some outlets hailed this as the fourth state-regulated psilocybin access system in the U.S., it does not create a psilocybin services system like those seen in Oregon and Colorado.

Instead, the legislation creates a two-year pilot program that will see the drug researched at three hospitals in New Jersey, which will each receive $2M, in accordance with FDA and DEA regulations. (Compare that, for example, to Oregon and Colorado, which defy DEA scheduling and are not aligned with FDA.)

The bill did originally envisage the creation of an Oregon-style system featuring service centres and the like. But it was stripped down as it progressed through the state legislature, much to the chagrin of some in the psychedelic policy reform movement.

We may see more state-sponsored psychedelic research bills pass in the coming months, with several introduced already. You can track 55 bills that are in motion in the state and at the federal level via our new Psychedelic Bill Tracker.

While legislators seem increasingly open to psychedelic policy initiatives, Americans remain somewhat divided, according to a new Ipsos/Psychedelic Alpha poll released this week. You can read the topline over at Ipsos and a deeper dive in our latest Bulletin.

Aside from their attitudes, we also got a look at how Americans are using psychedelics and related substances last week, as RAND shared the first cut of data from its 2025 survey. It reports, among other things, that around 10 million U.S. adults microdosed last year.

Elsewhere, our 2025 Year in Review looked at funding, public markets, and M&A activity in the field last year. We reported a relatively strong close to the year in terms of financing activity and a bullish sentiment on the public markets.

Our latest Op-Ed from that same Year in Review series came from Helena Aicher, a researcher and psychotherapist working within Switzerland’s framework for limited medical use. There, Aicher reflects on how Europe’s psychedelics landscape evolved in 2025.

It certainly seems like the pace of developments is not letting up, with plenty to cover on the policy reform side. Pα+ subscribers should keep an eye out for our first roundup of 2026 on that front.

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

The Psychedelic Bill Tracker

Pα+ Psychedelic Bill Tracker

Psychedelic Alpha ↗

Monitor the status of every psychedelics-related bill working its way through both state and federal legislatures in the U.S. with our new Psychedelic Bill Tracker.

Psychedelic Bulletin 218

Psychedelic Alpha ↗

  • FDA’s Farchione Says Psychedelic INDs Now “a Third” of Her Workload; NIDA’s Volkow Questions Schedule I Placement
  • Ipsos/Psychedelic Alpha Poll Probes Americans’ Attitudes Towards Psychedelics
  • RAND Estimates 10 Million U.S. Adults Microdosed Last Year
  • Reunion Targets Single Phase 3 Path in PPD; Releases Additional Phase 2 Data
  • MindMed Rebrands to Definium, Launches LSD Education Push
  • Interview: Independent Psychedelic Evidence Assessment Working Group
  • New Jersey Governor Signs $6M Psilocybin Pilot Program Into Law
  • and more


January 12-18, 2026

A Note from the Editor

The psychedelics field’s busy start to 2026 continued this week.

On Monday, MindMed unveiled a full overhaul of its brand, including a new name: Definium Therapeutics. In doing so, it became the second Phase 3 psychedelic drug developer to rebrand this year, after Cybin became Helus Pharma last week.

The companies are presumably hoping to distance themselves from their ‘shroom stocks’ vintage, with names like MindMed and Cybin perhaps indelibly associated with a 2021 ‘shroom boom’ that was driven in part by frothy markets and retail investor excitement. That era was replete with the likes of Kevin O’Leary, r/wallstreetbets analyses and, in the case of Cybin, some questionable stock promotion efforts.

Definium says its name is a combination of the Latin ‘definio’ and ‘infinitum’, literally meaning ‘to bound’ and ‘infinite’, respectively. Perhaps it reflects an ambition to sound equal parts transformative and nondescript, limitless but in a limited, safe kind of way.

Speaking of safety, U.S. National Institute on Drug Abuse (NIDA) Director Nora Volkow said last year that ibogaine is unlikely to ever receive approval for opioid addiction due to its cardiac toxicity, throwing cold water on a surge of interest in the drug that revved up in 2025 and continues to mount today.

But this week, Volkow shared an article on ‘Nora’s Blog’, which lives on the NIDA website, that asks: “Could psychedelics harness neuroplasticity to treat addiction and other mental illness?”

In it, the NIDA Director concludes that “[h]arnessing the brain’s natural plasticity in effecting therapeutic gains is an intuitively obvious avenue for drug development including the development of psychedelics as therapeutics”, adding that basic research might deliver value beyond new treatments, too. “The profoundly meaningful experiences some people report following use of psychedelics could give neuroscientists valuable insights into meaning-making and the ability of the brain to change in a healthy direction after addiction or trauma”, she went on.

Under Volkow, NIDA has funded trials on psilocybin for smoking cessation, psilocybin and ketamine in the treatment of opioid use disorder, and ketamine for stimulant use disorder; so it’s not as though Volkow has blocked such work via the Institute. But it is curious that the Director chose to pen this particular blog entry, which serves as a call for further research into psychedelics as therapeutics and provides a sketch of that research agenda, now.

Also on the research and drug development front, Reunion Neuroscience announced this week that it expects to conduct just one Phase 3 trial to support the approval of its 4-OH-DiPT candidate in postpartum depression. That comes after FDA signalled a shift toward expecting just one Phase 3 by default late last year. We shouldn’t expect every psychedelic drug developer to follow this path, however, with factors like target indications and a drug’s profile coming into play.

On the state front, New Jersey could fund psilocybin research via S2283, which passed the Senate earlier this week. The Act would establish a psilocybin research pilot program and fund it to the tune of $6M. It has now passed both chambers with convincing margins and sits on Governor Phil Murphy’s (D) desk awaiting a signature.

After a busy start to the week, the second half of the work week saw flashy headlines announce that former Senator Kyrsten Sinema is the subject of a lawsuit filed by the ex-wife of one of her staffers, Matthew Ammel. In a complaint that has now been transferred to federal court, Ammel’s ex-wife accuses Sinema of breaking up their marriage.

While, on the face of it, the story has little to do with psychedelics, the suit alleges that Sinema, a licensed clinical social worker, asked Ammel to bring MDMA on a work trip, where she apparently intended to “guide him through a psychedelic experience”.

Indeed, Sinema is an outspoken psychedelics advocate, particularly on the topic of ibogaine. She became interested in advocating for ibogaine, she told me last summer, after Ammel went to Mexico to take the drug and found it beneficial. But, as we have covered in these pages, some in the field have been keen to distance themselves from Sinema, as the former Democrat-turned-Independent politician was already controversial. Some tell me that she inserted herself as a spokesperson for the field, while in other cases, it does appear that she has been welcomed in, especially in some corners of the ibogaine advocacy push.

More: Last summer, I had a somewhat spiky interview with Sinema, who attended Psychedelic Science in Denver with Ammel and a colleague from Hogan Lovells. Later, in a Bulletin, I asked: “What is Kyrsten Sinema Selling?”

Ammel is facing legal troubles, too, after he allegedly threatened his rental property manager last November and was involuntarily committed to a hospital. There, he is accused of attempting to strangle a member of the hospital staff. He was taken to jail on felony charges and released on a $10,000 bond, with a hearing scheduled for the end of January.

It appears that Ammel has been in Gabon, the Central African country, this week taking part in the International Conference on Iboga and Ibogaine, which was co-organised by Americans for Ibogaine.

“Gabon is the ancestral home of iboga”, a statement by Americans for Ibogaine CEO Bryan Hubbard following the closing of the conference reads, “and we deeply value the conversations grounded in cultural respect, environmental stewardship, and science.”

It’s not clear that Sinema shares that view. When I was sitting with Sinema, Ammel, and their law firm colleague in Denver last summer, I asked the former Senator about her thoughts on the role of traditional knowledge-holders like certain groups in Gabon. The Indigenous perspective, she told me bluntly, “is not my problem”.

In that same interview, Sinema told me: “So, because you’re British and you don’t know me, one thing I will tell you is, I am well known for having no drama. I do not engage in drama.” But it certainly looks like the drama has found its way to Sinema, who is facing a fresh bout of media attention following the surfacing of the lawsuit. In Salt Lake City on Friday, hecklers disrupted Sinema’s conversation with Utah Governor Spencer Cox about
 disruption.

Tabloids aside, here at Psychedelic Alpha, our 2025 Year in Review shifts to focusing on perspectives from across the field. To that end, we published a Views from the Field piece where several experts share what they’re excited and concerned about for 2026, and an open question they hope to get more clarity on.

Elsewhere, we published an Op-Ed from Healing Advocacy Fund Executive Director Taylor West on ‘what state psychedelics programs are teaching us’, and a Guest Article by Monica Schweickle on how Australia’s ‘psychedelic experiment’ is panning out.

UBC also published a brief interview I did with them before the holidays. We spoke about why I founded Psychedelic Alpha nearly six years ago, how we aim to act as a counterbalance to both stigma and hype, what I’m expecting to see in psychedelics this year, and more.

This was a slightly longer Editor’s note than usual. If you enjoyed it and would like much, much more analysis and news, consider subscribing to Pα+ to receive all our content, including our flagship Bulletins.

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

January 5-11, 2026

A Note from the Editor

As expected, 2026 is off to a busy start, with the first full week of the new year delivering no shortage of headlines.

On the drug development front, FDA finally accepted GH Research’s inhaled 5-MeO-DMT Investigational New Drug (IND) application after placing it on hold for more than two years, clearing the way for a Phase 3 program that the company hopes to launch this year. AtaiBeckley, meanwhile, expects to launch its own Phase 3 5-MeO-DMT program in Q2, with its intranasal formulation. Both companies are targeting treatment-resistant depression.

FDA also accepted an IND from Compass Pathways, allowing it to progress with a Phase 2b/3 program studying its psilocybin candidate in PTSD. It hopes to begin screening patients in the coming months.

Elsewhere, Cybin officially rebranded to Helus Pharma and listed on the Nasdaq this week, ringing the bell on Monday morning. And Gilgamesh Pharma printed positive topline data from a Phase 2a study of its NMDA receptor antagonist, GM-1020, in major depressive disorder. It’s another win for the company, which sold its lead candidate, bretisilocin, to AbbVie last year in a deal valued at up to $1.2bn.

Here on Psychedelic Alpha, we discussed all of these updates, and much more, in our first Bulletin of 2026. As a reminder, our flagship Psychedelic Bulletins provide one-stop coverage of developments across the psychedelics field. Published multiple times a month, they synthesise news, data, and analysis into a coherent picture of how the field is evolving, helping readers maintain continuity and perspective over time. They’re exclusively for Pα+ members: subscribe today.

We also shared the third and final session from our 2025 Year in Review video series, where I walk you through what happened in 2025 and where the field stands today; what we might expect to see in 2026; and, some potential futures and broader open questions the field faces. Pα+ subscribers can now watch all of the videos in the series.

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 #217: Gilgamesh’s GM-1020 Prints Positive Topline; FDA Lifts Hold on GH Research’s 5-MeO-DMT IND; Compass Details Pivotal PTSD Trial Design; Cybin Becomes Helus

Psychedelic Bulletin 217

Psychedelic Alpha ↗

  • Gilgamesh Prints Positive Topline from Phase 2a Study of NMDA Receptor Antagonist for MDD
  • FDA Lifts Hold on GH Research’s Inhaled 5-MeO-DMT IND After More than Two Years
  • Cybin Rebrands to Helus Pharma, Lists on Nasdaq
  • Compass Details PTSD Trial Design, Reaffirms TRD Launch Readiness ‘By End of Year’
  • Emory Registers Trial of MDMA-Assisted Massed Exposure Therapy in Active Duty Troops
  • Filings Provide a Look at Psychedelics Nonprofits’ Finances
  • and more…

December 29 – January 04, 2025

A Note from the Editor

Happy New Year!

As we closed out the year, we highlighted the ten stories that defined psychedelic drug development, policy, and access in 2025. You can read those 10 standout stories now: we lifted the Pα+ paywall for all of the articles mentioned in our rundown for the month of January.

As 2026 gets underway in earnest, our 2025 Year in Review content begins to adopt a more forward-looking tone. This week, we published the second video in a three-part series where I look ahead to 2026 and consider potential FDA approvals, Phase 3 readouts, alternative pathways to access, and much more. Pα+ subscribers can watch the video now.

Things were relatively quiet in mainstream media this week. I hope that you, too, found a little bit of quiet ahead of what looks set to be a very busy year.

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

2025 Year in Review Video Series Part 2_ Looking Ahead to Psychedelics in 2026

Part 2: Looking Ahead to Psychedelics in 2026

Psychedelic Alpha ↗

đŸŽ„ Out now: Part 2 of our 3-part 2025 Year in Review video Series

Our Founder & Editor, Josh Hardman, looks ahead to 2026 via a narrated presentation. In this video, Hardman considers potential FDA approvals, Phase 3 readouts, alternative pathways to access, and more. Watch now on our website.

December 15 – 21, 2025

A Note from the Editor

This week, we published our last Bulletin of 2025, which featured interviews, policy and drug development updates, and a closer look at some recent research findings. Our attention now turns to planning for what is sure to be an eventful 2026, but not before we share our 2025 Year in Review.

This year, we’re doing things a little differently. While we will still share a couple of articles from our desk, a selection of global dispatches from guest authors, and Michael Haichin’s Interdisciplinary Annotated Psychedelic Research Bibliography, the core of our 2025 Year in Review coverage is in the form of a three-part narrated presentation that I have pulled together. In it, I share data and updates from around the world, as well as deep dives into specific topics, such as what I learned during a trip to D.C.

The first session, which looks back at 2025 and takes stock of where the field is today, with a primary focus on drug development and policy, will be shared early next week with our Pα+ subscribers. Join today to get access to the videos as they publish.

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 #216: Australia’s Psychedelics-for-Veterans Funding; New Mexico Targets 2026 Medical Psilocybin Launch; Radial Scores $50M; Otsuka’s “Novel Serotonergic Agonists”; Psilocybin Accelerates Brain Tumour Growth in Mice; Texas’ $50M Ibogaine Study Consortium

Psychedelic Bulletin 216

Psychedelic Alpha ↗

  • Australia’s Department of Veterans’ Affairs Explains World-First Funding Model for Psychedelic-Assisted Psychotherapy
  • New Mexico Targets December 2026 for Medical Psilocybin Launch
  • Otsuka Publicly Signals Work on “Psychedelic-Inspired” CNS Compounds
  • Psilocybin Promotes Growth of Existing Brain Tumours in Mice, Preprint Study Reports
  • Interview: Radial Scores $50M, Eyes Interventional Psychiatry—and Psychedelics
  • State of Texas Awards $50M to Ibogaine Study Consortium
  • Interview: Fireside Project Unveils AI Chatbot Aimed at Training Psychedelic Practitioners
  • Czech Medical Body Drafts Guidelines for Psilocybin Therapy, Targets 2026 Launch
  • and more…

December 8 – 14, 2025

A Note from the Editor

As the holiday period approaches, we at Psychedelic Alpha are busy focusing on the launch of several new features and pieces of content to round out 2025 and welcome the new year.

There’s little rest among psychedelics advocates, too. Outside of the traditional model of pharmaceutical approvals, where a regulator like the FDA gives a nod to new drugs, some countries and states continue to pursue psychedelic access pathways with a focus on launching next year.

In Europe, tweaks to Czechia’s criminal code will allow for medical access to psilocybin in 2026, for certain patients in specific contexts, as guidelines for the use of the drug have now been drafted by the country’s psychiatric society.

In the U.S., meanwhile, New Mexico’s Medical Psilocybin Advisory Board has brought forward plans for the launch of its state-regulated program by a year. It now hopes to allow the first patients to access psilocybin in December 2026. That’s around the same time that a pharmaceutical form of psilocybin could be up for FDA approval. It’s certainly going to be an interesting year.

At the federal level, a rumoured executive order to reclassify marijuana has been making headlines. If the supposedly imminent move materialises, psychedelics advocates will be watching closely for how MAGA reacts.

And, back at Psychedelic Alpha, we were pleased to publish the second Issue of The Psychedelic Practitioner earlier this week, which focuses on the topic of Psychedelic Preparation. The next Issue, which will be published in February, will focus on Dosing.

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

December 1-7, 2025

A Note from the Editor

This week, I shared my Dispatch from D.C., which reflects on my time speaking with lawyers, lobbyists, and advocates, but also agency staffers, drug developers, and well-connected individuals in an attempt to take the temperature on psychedelics among those who might shape the field’s future.

There is significant tumult not only across U.S. politics and the regulatory apparatus, but also within the psychedelics field itself, which does not appear to have landed on a clear or coordinated ‘ask’. But beneath the noise, there appeared to be a quiet confidence among some that multiple FDA approvals of psychedelics are close at hand, with as many as three possible over the next 18 months.

The day after that piece was published, STAT reported that the FDA will only expect one Phase 3 trial before considering a new drug for approval. While many drugs already receive approval on the basis of one pivotal study, psychiatric drugs are often put through two or more Phase 3 trials. In our latest Bulletin, I cover what this could mean for the psychedelics field.

We also cover the Freedom to Heal Act, which was introduced this week by Senators Cory Booker (D) and Rand Paul (R). It aims to ‘fix’ what its backers view as a ‘gap’ in federal Right to Try law that effectively excludes Schedule I substances, including psychedelics. Advocates are flying in to D.C. early next week to drum up support.

Outside of D.C., longevity enthusiast Bryan Johnson’s live-streamed ingestion of psilocybin mushrooms last Sunday generated buzz early in the week. While some applauded the online event as a laudable move to reduce stigma, others poked fun at the spectacle.

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 #215: FDA’s Move to Single-Trial Approvals; Freedom to Heal Act Looks to Unlock Right to Try Psychedelics; Compass Clarifies Q1 Readout Plans

Psychedelic Bulletin 215

Psychedelic Alpha ↗

  • One and Done? FDA to Approve Drugs on a Single Phase 3, What It Means for Psychedelics
  • Freedom to Heal Act Seeks to Close Federal Right to Try Gap for Psychedelics
  • Compass Clarifies Q1 Readout Plans
  • and more…

November 24 – 30, 2025

A Note from the Editor

It’s been a very quiet week in the psychedelics field, largely owing to the U.S. holiday.

We’re taking this moment to prepare for our 2025 Year in Review, and this time we’re looking to you, our audience, to contribute. Find out more and pitch a contribution. (The deadline for submissions is Friday 5th.)

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

November 17 – 23, 2025

A Note from the Editor

I just returned from a trip to Washington, D.C., where I found myself immersed in a notably optimistic psychedelics clique, with many expecting several significant developments in the next 18 months.

One of those developments has already come to fruition: ARPA-H’s $100M initiative to develop objective measures of mental and behavioural health. The initiative, which is one of the agency’s largest ever, looks set to feature psychedelic research substantially. (We were the first to cover that program’s reveal last Friday.)

There is plenty more coming down the pike, I am told, with 2026 set to be an incredibly busy year for the field. I will be writing up some of my field notes (a kind of ‘View from D.C.’) in the coming weeks, exclusively for our Pα+ subscribers.

Elsewhere this week, the largest trial of LSD microdosing to date found that it underperformed placebo across all endpoints in a population of 89 patients with major depressive disorder. The null finding is the latest blow to drug developers seeking to prove the efficacy of microdosing, and it becomes the second mid-stage low-dose LSD program to flop.

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 #214: LSD Microdosing Program Collapses; AtaiBeckley’s Phase 2b Debrief; UK Government Responds to MPs’ Psilocybin-Related Questions

Psychedelic Bulletin 214

Psychedelic Alpha ↗

  • Largest LSD Microdosing Trial to Date Fails Across All Endpoints
  • AtaiBeckley’s Phase 2b Debrief: More Detail on SAE and Phase 3 Considerations
  • UK Government Holds Line on Psilocybin Despite New Cross-Party Written Questions
  • MAHA Summit Features Psychedelics
  • VA Reveals Phase 3 Psilocybin Study
  • and more…

November 10 – 16, 2025

A Note from the Editor

I had a great time speaking at the UW-Madison Psychedelic Symposium this week. It’s my second time attending this event, which I appreciate for its remarkably interdisciplinary agenda: there was everything from preclinical studies of psychoplastogens (Katherine Nautiyal) through to the history of touch in psychedelic practice (ZoĂ« Dubus).

For my part, I provided a kind of ‘State of the Union’, presenting on the current state of psychedelic drug development, industry and policy, before considering some potential future directions and open questions. I was also glad to participate in a lively panel discussion. Besides being among my favourite meetings in the field, not least due to the Midwestern hospitality of the hosts and organisers, I was also grateful to have an excuse to spend some time updating my slides and adding some new ones. I hope to share an annotated copy with our Pα+ subscribers soon.

Psychedelics were also on the agenda at the ‘MAHA Summit’ in DC, a closed-door affair with a line-up including Vice President JD Vance and Health and Human Services Secretary RFK Jr. Psychedelics were discussed on stage by HHS lawyer and “psychedelics czar” Matt Zorn, who chatted with AtaiBeckley founder and chairman Christian Angermayer.

Speaking of the HHS Secretary, a new book by journalist Olivia Nuzzi, who says she had a close relationship with RFK Jr., claims that he told her he uses psychedelics and has smoked DMT.

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

November 3 – 9, 2025

A Note from the Editor

This week got off to a busy start with Compass Pathways announcing on Tuesday morning that it is bringing forward its launch planning by 9-12 months, following a positive meeting with FDA and the completion of enrolment in its second, larger Phase 3 study. The psilocybin developer is expected to be the first to secure FDA approval for the drug, which could come as early as late next year or early 2027.

That same day, we also learned, via an SEC filing, that AbbVie paid $900 million upfront for Gilgamesh Pharmaceuticals’ lead psychedelic candidate, bretisilocin. Until then, there had been no public disclosure of how much of the acquisition deal, which is valued at up to $1.2bn, was paid in cash. The answer, we now know, is 75%: well above what many expected. Some investors and operators in the field view this as evidence of AbbVie’s conviction around the candidate.

Also in the psychedelic drug development world, the merging of atai Life Sciences and Beckley Psytech closed this week, with the former now trading as AtaiBeckley.

Beyond the psychedelics industry, Global Psychedelic Week debuted with online and in-person programming across the world. I was pleased to participate by moderating a panel on funding, as well as having a discussion with psychedelics researcher Robin Carhart-Harris.

I am heading to Wisconsin next week for the UW-Madison Psychedelic Symposium, so please cross your fingers and toes for minimal flight disruptions! I had a great time last year and am looking forward to delivering the final presentation of the meeting on Friday afternoon. Thereafter, I have a short stint on the East Coast. I am excited to again meet with some of our readers in person.

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 #213: Compass Accelerates Psilocybin Launch Planning; Australian VA Funds Psychedelic Therapy for Veterans; AbbVie Paid $900M Upfront for Psychedelic Candidate

Psychedelic Bulletin 213

Psychedelic Alpha ↗

  • Compass Accelerates Psilocybin Launch Plans by Almost a Year
  • Australia’s VA Will Fund Psychedelic-Assisted Psychotherapy for Veterans
  • AbbVie Paid $900M Upfront for Gilgamesh’s Psychedelic Candidate
  • FDA Again Passes On Psychedelics, Mental Health, In Second Batch of Priority Vouchers
  • and more…

October 27 – November 02, 2025

A Note from the Editor

It’s been an incredibly active start to the fourth and final quarter of 2025.

In October, funding for psychedelics companies appears to have caught up with the positive sentiment exhibited in our Q3 Psychedelic Investor Survey. More than half a billion dollars was raised across three rounds alone last month (by atai, Cybin, and MindMed), meaning Q4 2025 will see the largest inflows to the space since mid-2021. There are still two months left of the quarter, meaning the heady days of 2021 could still be topped.

On the lobbying front, too, spend is ramping up. Our Psychedelics Federal Lobbying Tracker shows that psychedelic drug developers spent more than ever on U.S. federal lobbying in Q3, though the aggregate reported spend remains relatively modest at just north of $300k over the three-month period. Interestingly, Lykos Therapeutics has ceased its formal spend on federal lobbying, while Compass Pathways has more than doubled its own. What’s more, the Association for Prescription Psychedelics (which represents most of the late-stage developers in the field) began spending cash on lobbying activities in Q3, according to filings. (Pα+ subscribers can read our analysis of the latest data.)

On Friday, the Australian Government’s Department of Veterans’ Affairs announced that it has decided to fund psychedelic assisted therapy for veterans who meet certain criteria. It’s the latest in a string of psychedelics-related headlines from down under, which we will be covering in more detail very soon.

In the 212th Issue of our Psychedelic Bulletin, we looked at several other stories, including Delix Therapeutics’ efficacy signal from a small open-label study of its lead neuroplastogen and NRx Pharmaceuticals’ efforts to have FDA ban its competitors’ ketamine products.

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

New: Psychedelics Federal Lobbying Tracker

Psychedelic Alpha ↗

Here, we share several charts that visualise the extent of psychedelics organisations’ lobbying activities at the federal level, at least according to filings. ∎

Psychedelic Bulletin #212: Delix Posts Early Efficacy Signal; NRx Wants FDA to Ban Competitors’ Ketamine; Cybin Raises $175M

Psychedelic Bulletin 212

Psychedelic Alpha ↗

  • Delix Therapeutics Posts Early Efficacy Signal for ‘Non-Hallucinogenic’ Neuroplastogen as FDA Clears At-Home Phase II
  • NRx Pharmaceuticals Wants FDA to Ban Its Competitors’ Ketamine
  • Cybin Trades Toxic Financing for Top Tier Investors in $175M Raise
  • and more…

October 20 – 26, 2025

A Note from the Editor

This week was a fine example of how surging optimism among many in the psychedelics field exists alongside calls for a tempering of excitement.

Our analysis of the Q3 2025 Psychedelic Investor Survey revealed record levels of optimism and positive sentiment, yet actual financing data from the same quarter showed a drop in allocation to the field. Taken together, this suggests that funding is lagging sentiment.

But, last week, atai Life Sciences closed a $150M public financing on the back of its receipt of FDA breakthrough therapy status for BPL-003, Beckley Psytech’s intranasal 5-MeO-DMT candidate for treatment-resistant depression. (atai is in the process of acquiring Beckley.) Might this be the beginning of a more active fundraising environment to end the year?

Elsewhere, at least two recent studies have delivered null findings. A study of the longitudinal effects of psilocybin truffle microdosing found no enhancement in self-reported mood or cognition. And, a 62-participant study that saw participants receive IV ketamine or midazolam twice-weekly for four weeks found no significant difference in outcomes between the two groups. (We covered both in our most recent Bulletin.) The latter study, in particular, has sparked plenty of discussion among researchers.

In the mainstream media, BBC Future published an interesting look at the impact of Erowid, “the 30-year-old drug website that transformed psychedelic research”. Women’s Health, meanwhile, explored “why more midlife women are turning to psychedelics to heal their 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 #211: AbbVie Officially Enters Psychedelics; atai-Beckley’s 5-MeO-DMT Scores Breakthrough Therapy Designation; California Bill Signed

Psychedelic Bulletin 211

Psychedelic Alpha ↗

  • AbbVie Officially Enters Psychedelics as Gilgamesh Deal Closes, Patent Dispute Opens
  • BPL-003 Wins Breakthrough Status as atai Raises $150M
  • FDA Passes on Psychedelics in First Round of Priority Vouchers
  • California’s Newsom Signs AB 1103, Easing Review Bottleneck for Psychedelic Studies
  • Funding Lags Sentiment
. Or Does It?
  • and more…

October 13 – 19, 2025

A Note from the Editor

It’s been another busy week in the psychedelics field!

I’m currently in Japan, where psychedelic research is beginning to find its footing. Earlier this week, I met with Dr. Hiroyuki Uchida, a psychiatrist who is leading Asia’s first modern clinical trial of psilocybin therapy for treatment-resistant depression (TRD). I interviewed Dr. Uchida earlier this year (we published it in both English and Japanese), so it was a real pleasure to meet him in person at Keio University Hospital, a sprawling complex in the country’s capital.

I was struck by just how much work it takes to get a psychedelic trial started in a country like Japan. In many Western countries, psychedelic studies are quickly becoming part of the furniture, with entities like Institutional Review Boards increasingly familiar and comfortable with them. But Dr. Uchida and co. were, in many regards, starting from scratch when they set out to launch a study a few years ago. Aside from securing buy-in from the necessary stakeholders, Uchida’s group also had to translate scales like the mystical experience questionnaire (MEQ) and get the study drug into Japan, a country with notoriously strict drug laws. But he persevered, and today the trial has nearly finished dosing the twelve patients it aimed to enrol. I will share some more brief thoughts on Japan’s psychedelic research scene in our next Bulletin.

Outside of Japan, plenty has happened this week, including:

  • AbbVie’s purchase of Gilgamesh Pharmaceuticals’ lead psychedelic candidate, bretisilocin, has been completed (the candidate also appears to be the subject of a patent dispute: more to come next week, for our Pα+ subscribers)
  • The FDA did not award one of its new Commissioner’s National Priority Vouchers to a psychedelic drug developer, nor did it award one to any mental health program
  • But, FDA did award Breakthrough Therapy status to Beckley Psytech and atai Life Sciences’ intranasal 5-MeO-DMT candidate (BPL-003) for TRD
  • California Governor Gavin Newsom signed a psychedelics Bill into law, with AB 1103 seeking to catalyse psychedelic research in the Golden State by reducing a key bureaucratic hurdle

We will cover all this, and more, in Bulletin 211 next week, which is exclusively for our Pα+ subscribers.

Here on Psychedelic Alpha, we published a discussion I had with trauma and memory researcher Samuli Kangaslampi, as well as the Q3 update to our Psychedelic Financing Tracker, plus a summary of the latest funding developments for our Pα+ subscribers.

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

October 6 – 12, 2025

A Note from the Editor

It was a very busy week here at Psychedelic Alpha. On Thursday, we launched The Psychedelic Practitioner, a new publication designed specifically for therapists, clinicians, facilitators, and other professionals working with—or preparing to work with—psychedelic therapies and related treatments. Issue 1 is now available to read, and we welcome your feedback via the survey.

Friday was World Mental Health Day, which saw media outlets across the world spotlighting psychedelics’ potential in this realm. I was very pleased that my interview with journalist Dominique Nora was featured in French magazine Le Nouvel Obs’ Friday special. There, I discussed how the psychedelics field has changed in the past half-decade, what the pipeline looks like today, the challenges that psychedelic studies and rollout are facing, or might face, and a brief outlook on the future of the field.

Elsewhere, CBS News featured our U.S. psychedelic laws tracker in a segment on “The rise of psychedelic-assisted therapy for mental health treatment”, which saw Dr. Rachel Yehuda interviewed by the morning show’s anchors.

But the week ended on a sombre note, as we learned that Dr. Nolan Williams had died by suicide. Williams was a Stanford researcher whose work reshaped modern brain stimulation treatments for depression and suicidality. More recently, he became a prominent voice in the psychedelics research field, especially on the ibogaine front. This shocking news underscores the enormity of the struggle he fought to tackle through his own work. But those close to Williams have already expressed that his vision and compassion will continue to shape the field he redefined. Yesterday, psychiatrist Owen Scott Muir, who described Williams as both a friend and a hero, published a eulogy.

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

Sept 29 – Oct 5, 2025

A Note from the Editor

If you’re a podcast or radio fan, it’s a great time to be interested in psychedelics. Right now, you can listen to season 2 of the Altered States podcast, catch an episode on the evidence base for psychedelic medicine over at Undark, and enjoy a BBC Radio 4 segment on psychedelics for mental health hosted by Chris and Xand van Tulleken.

If you prefer to consume your media with your eyeballs, psychedelic scientist Manoj Doss and colleagues published a feature on ‘what we know, and what we think we know’ regarding how psychedelics affect the brain in The Scientist. Elsewhere, we published our latest Bulletin, which included our Dispatch from the Borealis Psychedelic Science Summit as well as updates from across the field.

On Wednesday, we unveiled our latest resource: The Psychedelic Perceptions Tracker. We combed through opinion polls, surveys, government reports, and other datasets to produce a curated series of headline figures, charts, and data visualisations on how various groups perceive and interact with psychedelics.

This coming week, we again have something new to share: The Psychedelic Practitioner, a publication designed specifically for therapists, clinicians, facilitators, and other professionals working with—or preparing to work with—psychedelic therapies and psychedelic-based treatments. Keep an eye out in your inbox for that first Issue next week.

Anyhow, without further ado: Here’s 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 #210

Psychedelic Alpha ↗

  • Dispatch: Borealis Summit Puts Compass’ Minimal Support Model Under Microscope
  • IV Ketamine Outperforms IN Esketamine in Retrospective Study
  • Reunion Advances RE104 While Academic Preclinical Study of Psilocybin Raises Postpartum Questions
  • Mindstate Completes Phase I Study, Teases First Fixed-Dose Combination Program
  • New York Assembly Discusses Psilocybin
  • Neurocentrx Secures $5M+ From Wellcome to Advance Abuse-Deterrent Ketamine Capsules and Digital Tool Combo
  • and more…

September 22 – 28, 2025

A Note from the Editor

I write this short note from Stockholm, Sweden, where the fantastic Borealis Summit just wrapped.

I gave a talk that provided an update of sorts on the psychedelic drug development pipeline as well as policy developments from around the world. It was among the driest topics, truth be told, with others exploring themes as rich as consciousness and meaning-making, challenging experiences, and gender and psychedelics.

As a Brit myself, I am very pleased to have reason to attend events and cover stories much closer to home, with Europe catching up with its North American counterparts in terms of psychedelic policy reform efforts, government-funded research, and so on. The continent, and the Nordics, are making their mark on the so-called psychedelic renaissance.

Elsewhere this week, we published a very long Issue of the Psychedelic Bulletin, which covers a whole host of topics: from atai Life Sciences’ $11.4M NIDA grant and Reunion Neuroscience’s $133M upsized Series A financing to a payor-backed psilocybin pilot program in Australia and real-world outcomes data from Oregon’s psilocybin services.

In the press, a New York Times feature has caused quite a stir. It details the story of venture capitalist Amy Griffin, whose immensely popular book, “The Tell”, recounts her story of recovering what she describes as a memory of sexual assault by a teacher during her childhood. The apparent memory was recovered, Griffin says, during an underground MDMA therapy experience. (Griffin was connected to the MDMA therapists via MAPS founder Rick Doblin. Her husband is a MAPS donor, and the pair invested in Lykos Therapeutics via their foundation.) The Times piece probes Griffin’s account and presents several questions that the book, and its popularity, raise. The case also draws focus on questions around psychedelic-induced recovered memories, which is quite a sensitive matter. During my time in Stockholm, I spoke to an expert on this topic; the interview will be published soon.

Anyhow, without further ado: Here’s 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 #209

Psychedelic Alpha ↗

  • atai Wins $11.4M NIDA Grant to Develop Non-Hallucinogenic Psychedelics for OUD
  • Australia’s Largest Private Health Insurer Funds Psilocybin for Treatment-Resistant Depression Pilot
  • Osmind and Bendable Share Real-World Outcomes from 88 Psilocybin Clients
  • Psychedelic Pipeline Bullseye Chart Update Log
  • Pennsylvania Lawmakers Talk Psychedelics in Hearing on Treatment-Resistant Depression
  • Reunion Upsizes Series A to $133M Following Phase 2 Success
  • Virtual Ketamine Startup Noma Therapy to Wind Down Operations
  • Feilding Commission Launches to Develop UK Framework for Psychedelic-Assisted Therapy
  • Neurocrine’s Osavampator Prints Positive Phase 2 Results
  • atai and Beckley Share Positive Open-Label Two-Dose Data
  • and more…

September 15 – 21, 2025

A Note from the Editor

Welcome to the hundreds of new subscribers who have joined us after exploring the latest versions of our signature Psychedelic Drug Development Tracker visualisations, which were published last week.

The timing of those fresh Bullseye Charts was, in hindsight, quite opportune, as it was a relatively quiet week
 for psychedelics, at least.

Other than a few media mentions, the only real news that broke was the UK Royal College of Psychiatrists’ new position paper and guidance booklet on the use of ‘psychedelic and related substances’, as they choose to refer to them. We covered both publications when they were made available on Friday morning.

Early next week, we will publish another bumper Issue of the Psychedelic Bulletin and a look at MindMed’s Phase 2b study of LSD for generalised anxiety disorder. Subscribe to Pα+ today to make sure you receive all of our Bulletins and articles. (More info / join here; or, reply to this email to discuss group/corporate plans.)

Anyhow, without further ado: Here’s your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.

Josh Hardman
Founder & Editor

September 8 – 14, 2025

A Note from the Editor

This week has been a little quieter, as the dust began to settle following the FDA’s publication of the Complete Response Letter it sent to Lykos Therapeutics last August, when it declined to approve its MDMA for PTSD new drug application. On Monday, we published a deep dive into the CRL’s contents, reactions from the field, and what it might mean for Lykos’ path to approval.

On Thursday, we shared a conversation I had with former EMA scientific expert Dr. Florence Butlen-Ducuing, where we discussed Europe’s psychedelic renaissance.

Elsewhere, both the LA Times and Wired ran stories on how athletes are turning to psychedelics, including ibogaine, to address brain injuries. And, STAT reports that psychedelics “are suddenly drawing interest from big drugmakers”, in a story that I was pleased to appear in.

Anyhow, without further ado: Here’s your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelics business, policy, research and beyond.

Josh Hardman
Founder & Editor

September 1-7, 2025

A Note from the Editor

This week looked set to be much quieter, with no real news to speak of for the first half, aside from Cybin’s ousting of its CEO, Doug Drysdale.

Then, on Thursday, our eagle-eyed Medical Advisor, Michael Haichin, noticed the FDA had released 89 previously unpublished complete response letters (CRLs) that it has issued to sponsors since 2024.

Among them was the letter it sent to Lykos Therapeutics last August, when it rejected its MDMA for PTSD new drug application. We broke the news on Thursday morning and will share a little more detail with our Pα+ subscribers on Monday.

Given that we were anticipating a quieter week (read: we tempted fate!), we used Bulletin 208 to look back at two conversations that took place at Psychedelic Science in June. One was an on-stage discussion between psychedelic drug development execs, while the other was a chat that I had with APA Division 56 President Jessica Punzo.

Anyhow, without further ado: Here’s 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 #208

Psychedelic Alpha ↗

  • Psychedelic CEOs’ FDA Wish-List
  • APA Division 56 President Jessica Punzo on Psychologists and Psychedelics
  • Compass’ Phase 2 PTSD Study Published
  • Cybin Ousts CEO Doug Drysdale
  • DoD to Test Military for Psilocybin
  • MindMed’s Phase 2b LSD for GAD Study Publishes
  • and more…

August 25 – 31, 2025

A Note from the Editor

Gosh, what a busy week! Monday saw two breaking news stories: AbbVie acquires Gilgamesh Pharmaceuticals’ lead psychedelic candidate in a transaction valued at up to $1.2 billion, and Norwegian regulators approved the use of public funds to cover generic ketamine for treatment-resistant depression. While the first of those two stories signals a growing appetite from ‘big pharma’ to dabble with true psychedelics, the latter story has upset some pharmaceutical firms, especially Johnson & Johnson (more on that here).

Later in the week, we learned that Lykos Therapeutics is renaming itself Resilient Pharmaceuticals, presumably in a nod to the fact that, despite decades of work and last summer’s FDA rejection, the MDMA drug developer keeps pushing on.

On Thursday and Friday, I took part in the Hopkins-Oxford Psychedelics Ethics (HOPE) workshop at The Oxford Union, which was a fantastic, intimate gathering of scholars and scientists (and, well, me!). I look forward to keeping tabs on HOPE’s future outputs.

Anyhow, without further ado: Here’s 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 #207

Psychedelic Alpha ↗

  • Lykos Therapeutics Rebrands to Resilient Pharmaceuticals
  • Pharma Pushes Back on Norway’s Off-Label Ketamine Decision
  • AbbVie–Gilgamesh Deal Viewed as Validation for Short-Acting Psychedelics
  • Psilocybin Rescheduling Petition Heads to HHS
  • Sensorium Scores $25M Series A Extension to Take Kanna-Based Candidate Into Clinic
  • Researchers Call Lykos’ MDMA Pricing Modelling “Problematic”
  • Alabama Board of Medicine Issues Guidelines for Off-Label Ketamine in TRD
  • FDA Approves PharmaTher’s Ketamine After Two CRLs
  • Incannex Reports Positive Phase 2 Results for Psilocybin-Assisted Psychotherapy in GAD
  • and more…

August 18 – 24, 2025

August 11 – 17, 2025

August 4 – 10, 2025

Psychedelic Bulletin #206

Psychedelic Alpha ↗

  • Q2’25 Psychedelic Lobbying Update
  • Tabernanthalog Spurs Neuroplasticity via Alternative Pathway, Davis and Delix Researchers Find
  • UK Moves Toward Easing Schedule I Research Restrictions But Keeps Industry at Arm’s Length
  • “Shell Games” and Whistleblowers: MassGOP Goes on Offensive Against Psychedelics Campaigners
  • Aussie University Seeks Public Comments on MDMA Clinical Practice Guideline
  • and more…

July 28 – August 3, 2025

Psychedelic Bulletin #205

Psychedelic Alpha ↗

  • AbbVie Eyes Billion-Dollar Gilgamesh Acquisition
  • What Is Kyrsten Sinema Selling?
  • Compass Pathways ‘Encouraged’ by Germany’s Psilocybin Compassionate Use Program
  • Psychedelics Industry’s Input on EMA’s Draft Depression Guideline
  • National Survey Reveals Psychedelics Use Again Rises in US
  • FDA Moves to Ban Kratom Compound 7-OH
  • Compass Talks Accelerated Approval on Q2’25 Earnings Call
  • atai All-In on Psychedelics Following RL-007 Flop
  • UK Government Publishes Life Sciences Plan
  • NMDA or Opioid? Ketamine’s True Target Under Scrutiny
  • Budget, Dosing, and Paperwork Raised at OPS Listening Sessions
  • and more…

July 21 – 27, 2025

Psychedelic Bulletin #204

Psychedelic Alpha ↗

  • FDA Keeps GH Research’s 5-MeO-DMT on Ice as atai and Beckley Surge Ahead
  • Makary’s Priority Voucher Program Launches, Cites Novel PTSD Treatment as Example
  • HALT Fentanyl Act Signed by Trump, Could Streamline Schedule I Researcher Registration for Some
  • FDA AdComm Skewers PTSD Drug Combo
  • Czech President Signs Medical Psilocybin Into Law
  • Psychedelic Stocks Surge, Compass Recovers from Readout Sell-off
  • New Zealand’s Medicines Regulator Publishes Guidance for Practitioners Applying to Prescribe Psychedelics
  • Psilocybin for Stroke Study Launches at Hopkins
  • Spravato Sales Continue to Increase
  • and more…

July 14 – 20, 2025

Psychedelic Bulletin #203: Norway Considers Funding Off-Label Ketamine for TRD; Longevity Crowd Hypes Psilocybin Study; Will State-Legal Psychedelics Eat Psychedelic Pharma’s Lunch?

Psychedelic Bulletin #203

Psychedelic Alpha ↗

  • Norway’s Health System Considers Funding Off-Label Ketamine for Treatment-Resistant Depression
  • Spravato’s Monotherapy Success Puts Pressure on Psychedelics Developers
  • Longevity Crowd Hypes Psilocybin Study But Researchers Urge Caution
  • Will State-Legal Psychedelics Eat Psychedelic Pharma’s Lunch?
  • Three Years of Psychedelics Access via Canada’s Special Access Programme
  • The New Neuroplastogen Developer on the Block
  • and more…

July 7 – 13, 2025

June 30 – July 6, 2025

Oregon Psilocybin Services Tracker_ Q1 2025

Q1 2025: Oregon Psilocybin Services Tracker

Psychedelic Alpha ↗

As the first cut of data from Oregon’s psilocybin program becomes available, we take a deep dive into emerging trends through various data visualisations and analysis. This marks the first instalment of our new Oregon Psilocybin Services Tracker, which will produce analysis of each cut of data as it is released.

June 23 – 29, 2025

Psychedelic Bulletin #202

Psychedelic Alpha ↗

  • RFK Jr. Envisages Psychedelics Access ‘Within 12 Months’
  • Psychedelics in Washington: FDA, VA, and New Political Signals
  • Lykos Therapeutics’ New CEO and CMO, Amy Emerson Joins Board
  • New Zealand Approves First Psilocybin Prescriber
  • DEA Judge Recommends Schedule I Placement for DOI and DOC
  • First Legal Psilocybin Sessions in Colorado
  • GH Research Submits IND Hold Response as 5-MeO-DMT Race Heats Up
  • Dutch Cabinet Responds to MDMA State Commission
  • and more…

June 16 – 22, 2025

June 9 – 15, 2025

Psychedelic Bulletin #201

Psychedelic Alpha ↗

  • The Psychedelics Circuit: Dispatches from Prague and London, Looking Ahead to Denver
    • EU Member States as Laboratories of Democracy? Conference Discusses Czechia’s Psychedelic Future at Prague Castle
    • At ‘the Davos of Mental Health’, Investors Eye Psychedelics’ Next Chapter
    • Join Us in Denver: Psychedelic Alpha at Psychedelic Science 2025
  • High-Dose LSD Shows Potential in Depression Trial, But Findings Are Fragile
  • Lone Star State Becomes Leader in Ibogaine Research
  • One-Year Outcomes from Psilocybin Study in Veterans with TRD
  • A Series of Unfortunate Events: Recent Incidents Underscore Psychedelic Safety
  • and more…

June 2 – 8, 2025

Psychedelic Bulletin #200

Psychedelic Alpha ↗

  • The Class of Bulletin 100: Where Are They Now?
  • Can Czechia Deliver on Psilocybin Access and Provide a Model for the Continent?
  • A Closer Look at atai’s Potential Acquisition of Beckley Psytech
  • Q1’25 Psychedelic Lobbying Update
  • Holy Trips and Hot Takes: Religious Leaders Study Finally Published
  • and more…

May 26 – June 1, 2025

Pα+ Psychedelic Bulletin #199

Psychedelic Alpha ↗

  • New CEO Tapped as Gracias and Hohn Close In on Lykos Therapeutics Takeover
  • Data Reveals Fewer than 100 Patients Received Psychedelics in Australia During First 18 Months of Access
  • Ibogaine Bill Clears Texas Legislature Amid THC Crackdown
  • and more…

Amanda Feilding

Drug Science ↗

“Her legacy is one of courage, curiosity, and an unshakable belief in the power of love over fear.”

May 12 – 18, 2025

Pα+ Psychedelic Bulletin #197

Psychedelic Alpha ↗

  • Bridging Promise and Prudence: Portuguese Health-Related Professions Unite to Release First National Guidelines on Psychedelic Therapy
  • Shrooms, Shots, and the Next Surgeon General: Psychedelics at the Centre of MAGA Infighting
  • ‘No One Has the Right to Speak for Us’: Religious Leaders Who Participated in Hopkins Study Push Back on Critics As Publication Nears
  • Manvir Singh Challenges the Stories Westerners Tell About Psychedelics’ Past
  • Compass Pathways Sets Expectations Ahead of June Readout
  • and more…

May 5 – 11, 2025

Pα+ Psychedelic Bulletin #196

Psychedelic Alpha ↗

  • Otsuka Eyes Psychedelic Future in Japan with New Infrastructure Drive
  • ASCP 2025 Preview: Psychedelic Therapies Dominate Clinical Psychopharmacology Agenda
  • First Look at Gilgamesh’s Phase 2a Data: Psychedelic Candidate Yields Effect Size of ~1.0, But Sparse Details
  • VA Secretary Pressed for Details on Psychedelics Plans
  • and more…

April 28 – May 4, 2025

Pα+ Psychedelic Bulletin #195

Psychedelic Alpha ↗

  • Psychedelics Namechecked in Trump Cabinet Meeting
  • Interview: Noma Therapy Raises $4.25M, Aims to Disrupt At-Home Ketamine With Insurance-Friendly Approach
  • Interview: Christian Angermayer: Keep Politics Out of Psychedelics—And Bitcoin on the Balance Sheet
  • and more…

April 21 – 27, 2025

Pα+ Psychedelic Bulletin #194

Psychedelic Alpha ↗

  • Europe’s Next Chapter in Psychedelic Therapy Begins in Barcelona
  • Make-or-Break Moment Looms for Compass Pathways
  • Makary Outlines Vision for Faster Drug Approvals
  • RFK Jr. Details Teenage Acid Trip That Preceded Years of Addiction
  • Enthea Ventures into Oregon’s Psilocybin Services
  • A Neuroimmune Theory of Psychedelic Action?
  • Pilot Study Explores Psilocybin for Mood Dysfunction in Parkinson’s Disease
  • and more…

April 14 – 20, 2025

April 7 – 13, 2025

Pα+ Psychedelic Bulletin #193

Psychedelic Alpha ↗

  • ‘Everything’s On the Table’: VA Secretary Signals Openness to Psychedelics, But Concrete Plans Lacking
  • Drug Developers Caught Between Tariff Talk, Agency Shake-Ups, and Market Mayhem
  • Multi-Lab Preprint Study Challenges Replicability of Psilocybin’s Persistent Effects in Mice
  • and more…

March 31 – April 6 2025

Behind the Bill_ Inside a Bipartisan Effort to Bring Psychedelic Therapy to Veterans with Melissa Lavasani and Amy Rising

Behind the Bill: Inside a Bipartisan Effort to Bring Psychedelic Therapy to Veterans

Psychedelic Alpha ↗

Yesterday, Representatives Lou Correa (D) and Jack Bergman (R) introduced the Innovative Therapies Centers of Excellence Act. The bipartisan bill—co-sponsored by Reps. Morgan Luttrell (R), Ro Khanna (D), and Dan Crenshaw (R)—would see the VA designate at least five such centres, which would focus on researching and delivering certain psychedelic therapies. Here, we speak to two of the bill’s architects…

March 24 – 30 2025

Pα+ Psychedelic Bulletin #192

Psychedelic Alpha ↗

  • Psychedelic Safety Takes Centre Stage in Berkeley
  • Selection Bias and Small Sample Size Hampers Compass Pathways’ Long-Term Psilocybin Data
  • Placebo Outperforms LSD in MindMed’s Microdosing Study for ADHD
  • atai Bets on Bitcoin
  • Potential Tweak to Ukrainian Law Could Permit Psychedelic Research
  • Governor of Virginia Vetoes Compass Pathways Rescheduling Bill
  • and much more…

May 19 – 25, 2025

Pα+ Psychedelic Bulletin #198

Psychedelic Alpha ↗

  • New Data Offers Look at Spravato’s Long-Term Use, Highlights Opportunity for Psychedelics
  • MAHA Report Slams Psychiatric Drug Use Among America’s Youth
  • Beckley’s Small Study Supports Adjunctive Use of 5-MeO-DMT with SSRIs in TRD
  • and more…

March 17 – 23 2025

Pα+ Psychedelic Bulletin #191

Psychedelic Alpha ↗

  • De-Weirding Psychedelics, SXSW
  • Psilocybin for Alcohol Use Disorder: Swiss Study Finds No Impact on Drinking
  • HALT Fentanyl Act Could Streamline Schedule I Research
  • Compass Pathways on Phase 3, REMS, and Potential Tailwinds
  • Government Accountability Office Issues Note on Psychedelics
  • and much more…

March 10 – 16 2025

March 3 – 9 2025

Psychedelic Bulletin #190: ‘Europe’s Most Feared Investor’ Teams Up with Musk Associate to Fund Lykos Therapeutics

Pα+ Psychedelic Bulletin #190

Psychedelic Alpha ↗

  • ‘Europe’s Most Feared Investor’ Teams Up with Musk Associate to Fund Lykos Therapeutics
  • Risk-Off or Reality Check? Psychedelic Stocks Slump After RFK Jr. Surge
  • Beckley Wraps Enrolment for Phase 2b Study of 5-MeO-DMT in Treatment-Resistant Depression
  • and more…

February 24 – March 2, 2025

February 17 – 23, 2025

February 10 – 16, 2025

Psychedelic Bulletin 188

Psychedelic Alpha ↗

  • Q4’24: Federal Psychedelics Lobbying Update
  • GH Research Discusses Lack of Placebo Effect, Decision to Keep Trial Sites Secret
  • Virginia Lawmakers Question Purpose and Precedent of Compass Pathways’ Rescheduling Bill
  • VA Psychedelics Champion Leaves Post
  • Colorado’s Psychedelics Program Sees Slow Start
  • Lykos’ FDA Rejection in Context
  • Center for MINDS Backs Psilocybin for Creativity Study
  • Study Reveals Differing Views on Psychological Support
  • and much more…

When The Smoke Clears

LA Times (via YouTube) ↗

An LA Times short documentary will premiere on February 18th. It follows two first responders who travel to Mexico to undergo psychedelic therapy in the hopes it will help their PTSD and depression.

February 3 – 9, 2025

Pα+ Psychedelic Bulletin #187

Psychedelic Alpha ↗

  • The Psychedelic Blame Game: NYT Report Fuels Controversy Over MDMA Rejection
    • Mixed Messages on Psymposia’s Role
    • Lykos and MAPS Seize the Opportunity
    • Political Pragmatism Sparks Backlash Among Some Supporters
  • Psychedelic Drug Developers Reflect on “Lykos-Specific Issues” and the Road Ahead
    • FDA “Wanted to Approve” MDMA, Says MindMed Exec
    • Trump on Psychedelics; “Nothing” Lies Beyond Psychological Support; Trial Site Availability Limits Psychedelic Drug Development
  • GH’s 5-MeO-DMT Data and RFK Jr. Confirmation Send Psychedelics Stocks Soaring
  • and much more…

January 27 – February 2, 2025

February 1-7, 2025

January 20 – 26, 2025

Pα+ Psychedelic Bulletin 186

Psychedelic Alpha ↗

  • As Trump Takes Office, Impact on Psychedelics Field Remains Unclear
    • Psychedelics Advocate Sergey Brin Bags Seat in Billionaire’s Gallery
    • When MAHA?
    • NIH Freeze Stokes Funding Fears; Might Psychedelics Benefit?
  • Psychedelic Power Couple, the Jurvetsons, Talk Trump, Lykos, and Philanthropy at Munich Conference
    • Genevieve Jurvetson Hopes to Get MDMA Approved This Year
  • J&J Buys Intra-Cellular for $14.6 Billion
  • Lykos Provides Update on Board Departures, FDA Meeting, and U.S. Patent Applications
  • GH Research Shares Positive Results from Proof of Concept Studies; Provides Update on FDA Clinical Hold
  • and more…

January 13 – 19, 2025

HELP WANTED

↗

Psychedelic Alpha is looking for someone to help us share our content on social media and other platforms. The right person is familiar with the psychedelics field, is able to summarise our content and pull out key themes or quotes, and has graphic design skills. If you are interested in this position, please contact hello@psychedelicalpha.com with one or two sentences about yourself and any samples of your work.

January 6 – 12, 2025

Pα+ Psychedelic Bulletin #185

Psychedelic Alpha ↗

  • Joe Rogan on Ibogaine: Rick Perry and Bryan Hubbard Appear in Two-Hour Interview
  • On Psychedelic Lobbying (Otsuka Joins In)
  • Neumora’s Kappa Opioid Receptor Drug for Depression Fails in Phase 3
  • Wisconsin’s Medicaid System to Cover IV Ketamine for Major Depressive Disorder
  • Inside the Plan to Make Lykos MAPS Again
    Other Stories
  • Tacoma Set to Vote on Psychedelic Decrim.
  • APA Special Issue, APA Workshops and Webinars
  • Colorado Regulator’s Last-Minute Changes
  • and more


Billionaire Investor Antonio Gracias Plots $100M Lykos Takeover with Doblin’s Backing

Psychedelic Alpha ↗

This latest twist in the Lykos Therapeutics saga threatens a major overhaul of the company’s strategy and direction, with Musk ally and billionaire investor Antonio Gracias appearing to want to take the company back toward its nonprofit drug development roots and a more Doblinite philosophy. Now, the company’s board must decide whether to stick with its current lead investor, Helena, or accept Gracias’ proposal.

December 30, 2024 – January 5, 2025

Pα+ Psychedelic Bulletin #184

Psychedelic Alpha ↗

  • We explore psychedelics-related lobbying activity at the federal level in Q3’24, which saw a significant increase in such efforts
  • Psychoplastogens a ‘primary focal point’ of depression trials last year
  • NJ Psilocybin Bill Appears Dead
  • FDA moves to restrict Amanita muscaria
  • DEA increases DMT production quota
  • and more


December 23 – 29, 2024

December 16 – 22, 2024

Pα+ Psychedelic Bulletin #183

Psychedelic Alpha ↗

  • Reflecting on UW Madison’s Fourth Annual Psychedelic Symposium
  • MindMed Doses First Patient in Phase 3 LSD Program
  • Beckley Psytech Shares Small Cut of Data from Phase 2a Study of IV Psilocin in MDD
  • Trial Suggests Psilocybin Could Help Clinicians With COVID-Related Mental Health Issues
  • Naropa Spins Off Psychedelics Centre to Avoid Federal Illegality
  • Awakn Life Sciences Set to Be Acquired
  • and more…

December 9 – 15, 2024

Pα+ Psychedelic Bulletin #182

Psychedelic Alpha ↗

  • Psychedelics Insiders Draw Up Trump 2.0 Wishlist
  • Rick Doblin Reflects on Lykos’ Strategy as MAPS Settles with FDA
  • Polish Medical Research Agency Set to Provide PLN 16M ($4M) to Psilocybin Study
  • VA Issues Note on Psychedelics for PTSD; Officially Funds Psychedelics Study
  • Alleged Killer of UnitedHealth CEO Apparently Interested in Psychedelics
  • Other Stories including: MDMA Plus Massed Exposure Therapy Protocol Published; Pollan Pushes Back on RFK Jr. Hype; Greenbrook TMS Stock Slumps Following Q3 Earnings; 30 Magic Mushroom Hops Shutter in Ontario; Expression of Concern Issued Over MAPS/Lykos Journal Article; Relmada Therapeutics’ Phase 3 MDD Drug Fails; and more


Bullish on Chaos_ Matt Zorn on How Psychedelics Could Benefit from Trump’s Second Term

Bullish on Chaos: Matt Zorn on How Psychedelics Could Benefit from Trump’s Second Term

Psychedelic Alpha ↗

After years of challenging the U.S. government over its drug laws and their application, lawyer Matt Zorn is bullish about the potential regulatory openings that an incoming Trump administration might present. Here, he discusses the types of ‘deeper questions’ we might ask about the U.S. system of drug and medicines regulation and how we might begin to reimagine it.

December 2 – 8, 2024

Inside the FDA’s Psychedelics Journey_ Javier Muniz, MD on Breakthroughs, Challenges, and the Future of the Field

Interview: Inside the FDA’s Psychedelics Journey: Javier Muniz, MD on Breakthroughs, Challenges, and the Future of the Field

Psychedelic Alpha ↗

Psychedelic Alpha’s Josh Hardman speaks with Javier Muniz, MD, who recently left his post as Associate Director at the FDA’s Division of Psychiatry. In that role, Muniz was at the heart of the agency’s psychedelics learning journey and helped formulate its view on thorny topics in psychedelic drug development like functional unblinding and the role of psychotherapy. This interview is far-reaching and provides a unique look into both the mind of the regulator, but also Muniz’s own views on psychedelics, now that he is unencumbered by his position in the agency.

Aaron Rodgers: Enigma (Trailer)

Netflix (YouTube) ↗

The trailer for a Netflix documentary which follows NFL star Aaron Rodgers has been released, with the film set to drop on December 17th. It prominently features his use of ayahuasca.

November 25 – December 1, 2024

November 18 – 24, 2024

Pα+ Psychedelic Bulletin #181

Psychedelic Alpha ↗

  • Last-Minute Rule Changes, Opt-Outs, Ahead of Colorado’s Psychedelics Program Launch
  • Cybin’s Impressive 12-Month Data Overshadowed by Small N and Controversial Marketing Move
  • DEA Extends Telemedicine Rules for Controlled Substances Through 2025
  • Vermont Psychedelic Therapy Advisory Working Group Kicks Can Down the Road
  • Other Stories including: $PSY Sells Out, Raising $2 Million for Psychedelic Science; Johns Hopkins Launches Psilocybin Microdosing Study; New Industry Association Launches; Kentucky Ibogaine Initiative Figurehead Relocates Effort to REID Foundation; and Lawmakers in Georgia Consider Spending Up To $5 Million on Psychedelic Research for Veterans. Read all about it…

Cybin Reports Positive Phase 2 Data for CYB003, Demonstrating Breakthrough 12-Month Efficacy in Treating Major Depressive Disorder

Press Release ↗

The company reports 12-mo efficacy data from a Phase 2 study of its deuterated psilocin candidate, CYB003, in major depressive disorder (MDD). The results are impressive, with 100% of patients responders and 71% in remission at the 12-month mark. The sample is small, however, with just 8 participants represented in the cut of data, 7 of which received two 16 mg doses (the remaining participant received just one dose). The company announced the commencement of its Phase 3 program last week.

November 11 – 17, 2024

Pα+ Psychedelic Bulletin #180

Psychedelic Alpha ↗

  • Massachusetts’ Psychedelics Ballot Question Post-Mortem Begins
  • Cybin Commences Phase 3 Program of Deuterated Psilocin, CYB003, in Major Depressive Disorder
  • Opt-Out Trend Continues: Oregon’s Local Jurisdictions Push Back on Psilocybin Access
  • CaaMTech Claims It’s Solved Functional Unblinding, But Won’t Tell Us How
  • Compass Says Phase 3 Readout Punt Is About Durability, Not Unblinding
  • Lykos-Funded Study Finds MDMA-AT Cost Effective with Drug Priced at $12k per Session
  • Other Stories including: RFK Jr. Scores HHS Position; UC Davis Researchers Claim Separation of DOI’s Hallucinogenic and Anxiolytic Effects; Relmada Launches Ph 1 Study of Low-Dose Psilocybin; Numinus Sells Clinics; and more…

November 4 – 10, 2024

October 28 – November 3, 2024

Final Stretch for Question 4: Controversy, Advocacy, and Celebrity Voices Shape Psychedelic Vote

Psychedelic Alpha ↗

Jack Gorsline shares the latest view from Massachusetts, where psychedelics advocates and detractors are hoping to sway voters to mark a ‘yes’ or ‘no’ next to Question 4 next week. The Yes campaign feels that coverage by The Harvard Crimson was unfair, a key anti-Question 4 campaigner appears to have misrepresented his group’s potential participation in a debate, the No campaign receives its first major donation, and more…

Compass Pathways Pushes Back Phase 3 Readouts, Lays Off 30% of Staff

Psychedelic Alpha ↗

This morning, Compass Pathways announced delays to both of its Phase 3 studies, as well as a major reduction in force that sees its preclinical programs and digital tools effectively shelved. Here, we provide our analysis along with coverage of the company’s earnings call and associated discussion.

Pα+ Psychedelic Bulletin #179

Psychedelic Alpha ↗

  • VA Funds MDMA for PTSD and AUD Study, Chooses Low-Dose MDMA as Control
  • A Look at the Latest Oregon Psilocybin Services Complaints
  • Zuranolone’s MDD Journey Ends
  • Tryp Therapeutics Raises $6M to Forward IV Psilocin Candidate
  • Psylo and Co. Win $3M Grant to Develop Neuroplastogens
  • Other Stories

October 21 – 27, 2024

Searching for New Cures from Ancient Medicines

Yale ↗

A new named professorship supports Deepak Cyril D’Souza’s research on the potential for psychedelic drugs to treat post-traumatic stress disorder and depression.

Free Event: Cultivating Connections II (Nov 1, Hybrid)

Register ↗

UCLA’s Ecological Medicine & Psychedelic Studies Initiative is hosting a one-day hybrid event that aims to bridge mental health, Indigenous perspectives, legal rights, city planning, ethnobotany, conservation, ecology, and psychedelic therapies… gosh! Free to attend.

Pα+ Psychedelic Bulletin #178

Psychedelic Alpha ↗

  • Lykos’ Path to FDA Approval Might Include a Third-Party Review of Phase 3 Data, VA Funding of Phase 3 ‘Definitely a Possibility’
  • Precision Psychiatry Platform Under Pressure as Alto’s ALTO-100 Fails in MDD Trial
  • Antidepressant Withdrawal Doesn’t Diminish Psilocybin Efficacy, Compass Study Suggests
  • Massachusetts Miscellany: MAPS Boosts Funding for Yes on Question 4
  • Czech Republic Establishes Unique Category for Low-Risk Psychoactive Substances, Skirting International Drug Controls
  • Other Stories, including: Imperial Wins UK Government Funding for Psilocybin Study; Seaport Therapeutics Scoops $225M Series B; FDA Issues Complete Response Letter to PharmaTher; and more.

Natural Medicine Advisory Bulletin 14

Psychedelic Alpha ↗

Vicente LLP looks at big-picture questions as the program hurtles towards launch. First up are fees and rule changes, before the firm reviews Natural Medicine-related meetings since our last Bulletin in late August.

Tripping on Nothing

The Atlantic ↗

Shayla Love explores how “new, non-hallucinogenic versions of psychedelics are blurring the boundaries of the drug trip. (* Included here as it just missed the cut-off for last week’s Feed.)

Survey: Exploring Psychedelic Experiences, Belief Systems, and Mental Health

CharitĂ© University ↗

If you’ve had personal experience with classic psychedelics—such as LSD, psilocybin, ayahuasca, DMT, or mescaline—you are invited to take part. The survey takes approximately 30 minutes to complete and is best experienced on a computer or in landscape mode on a mobile device.

October 14 – 20, 2024

Pα+ Psychedelic Bulletin #177

Psychedelic Alpha ↗

  • 5-HT2C Fever: Bright Minds Surges on Longboard’s Seizure Drug Success, But Is It Still a Psychedelics Company?
  • Kasvu Therapeutics: Psychoplastogens, With a TrkB Twist
  • Other stories from the Cambridge Psychedelic Research Group, Awakn Life Sciences, Janssen, AMCP Nexus 2024, and more.

Why voters should pass Question 4

Boston Globe ↗

Bessel van der Kolk encourages Massachusetts voters to get approve the psychedelics question this November.

Lykos Therapeutics Statement on Recent FDA Meeting

Lykos Press Release ↗

Lykos Therapeutics has provided an update on a recent meeting with the FDA re: its MDMA for PTSD New Drug Application. The very brief 100-word statement reveals that the ‘path forward’ for the program will include an additional Phase 3 trial, but could also entail an independent, third-party review of the two existing Phase 3 studies (MAPP1 and MAPP2).

Why traditional plant knowledge is not a quick fix

NPR ↗

Host Regina G. Barber talks with Rosalyn LaPier about ethnobotany–what it is and how traditional plant knowledge is frequently misunderstood in the era of COVID and psychedelics. 

October 7 – 13, 2024

Pα+ Psychedelic Bulletin #176

Psychedelic Alpha ↗

  • Psychedelic Drug Developers Discuss Trial Design at Investor Event
  • Too Close to Call: Massachusetts Voters, Donors, to Decide Fate of State-Level Psychedelic Policy Reforms
  • Mushroom Mirage: SEC Charges Early Psychedelics Stock and Associates Over “Multimillion Dollar Pump-and-Dump” Scheme
  • Other stories.

THE FIGHT FOR QUESTION 4 IN MASSACHUSETTS

↗

As the U.S. elections draw closer coverage of Massachusetts’ Question 4 is heating up, too. If voters endorse the ballot question the state would be tasked with decriminalising certain naturally-occurring psychedelics and establishing a regulated program similar to Oregon’s. But polling shows that the vote is currently too close to call, with donors pouring last-minute funding into the Yes campaign (See Bulletin 176 for more).

September 30 – October 6, 2024

Pα+ Psychedelic Bulletin #175

Psychedelic Alpha ↗

  • atai Sells a Third of Compass Stake to Raise Cash for In-House Programs
  • Lykos’ Unproven Psychotherapy Hampered Studies, Claim Authors of New Viewpoint
  • Picking Placebos for Psychedelic Studies
  • Small Study of Psilocybin in Severe TRD Among Veterans Shows Promise, But Authors Encourage Tempering Expectations

September 23 – 29, 2024

Pα+ Psychedelic Bulletin #174

Psychedelic Alpha ↗

  • Six-Month Follow-Up Data Shows Psilocybin Outperforms Escitalopram
 or Does It?
  • Survey Reveals Healthcare Practitioner Attitudes to Psychedelics
  • MIND Foundation Plots 700-Patient Psilocybin Study
  • Beckley Psytech-affiliated Study of Low-Dose Psilocybin for Headache Disorder Terminated Due to Recruitment Difficulties

September 16 – 22, 2024

Pα+ Psychedelic Bulletin #173

Psychedelic Alpha ↗

  • Upcoming Trial Readouts to Watch
  • Lykos Prioritises Preparing for Resubmission Over Formal Dispute
  • Bogenschutz Scores $3.8m NIAAA Grant for Psilocybin in Alcohol Use Disorder Study
  • FDA Issues Decentralised Clinical Trials Guidance
  • New Mental Health Parity Regs Come Into Force in January 2025
  • More Headlines from Cybin, Bright Minds Biosciences, Richard Branson, Psychedelic Industry UK, Incannex, Big Health, Lophora, and others.

UK’s First Psychedelics Tade Association Launches.

↗

Earlier this week, Psychedelic Industry UK (PsyIndUK) announced its launch. The new association says that it aims to represent the country’s ‘psychedelic medicine and wellness sector’, with founding members including Heroic Hearts Project UK, Onaya, and Imperial College London’s Centre for Psychedelic Research.

11 people shaping psychedelics drug development

STAT ↗

Robin Carhart-Harris; Christian Angermayer; Ekaterina Malievskaia and George Goldsmith; Srinivas Rao; Rick Doblin; Matthew Baggott; David Nutt; Robert Barrow; Doug Drysdale; Michael Mullette.

September 9 – 15, 2024

Real-World Data Reveals Variability in Access to, and Use of, Spravato

Psychedelic Alpha ↗

While Janssen’s Spravato is on-track to become a blockbuster drug, access to the esketamine nasal spray product continues to be a key Acchiles heel for patients and their providers. Here, through study of two recent publications and interviews with their authors, we look at variability in access to, and real-world usage of, the therapy that psychedelic drug developers are increasingly hoping to imitate.

Expanding Minds

The Assembly ↗

A small nonprofit clinic in Waynesville, North Carolina has been part of a national movement to broaden the use of MDMA to treat post-traumatic stress disorder.

Pα+ Psychedelic Bulletin #172

Psychedelic Alpha ↗

  • Lykos Scales Back Investigator-Initiated Trials Program, Refers Some Researchers to PharmAla
  • Lykos Appoints ‘Pharma Veterans’ to C-Suite
  • Psyence Scoops Up Clairvoyant for Peanuts
  • Mindstate’s Moxy Enters Phase I Trial
  • Embattled Braxia Bought for $180k
  • UK Gov. Unveils ÂŁ400m Plan to Catalyse Clinical Trials
  • GH Research Waiting on Tox Studies to Respond to FDA’s Clinical Hold
  • Cydex Sues Bexson Over Psychedelic Salt Patents
  • Other Stories

September 2 – 8, 2024

Exclusive_ David Hough on Lykos’ Path to Resubmission

Exclusive: David Hough on Lykos’ Path to Resubmission

Psychedelic Alpha ↗

Josh sits down with the man drafted in by Lykos Therapeutics to plot a path to resubmitting its MDMA application. They talk about Hough’s experience in developing Spravato to eventual approval and how that might inform any future clinical development of MDMA, Hough’s thoughts about the FDA’s verdict and the AdComm that preceded it, what a future Phase 3 program might look like, and more


Psyence Biomed Announces the Signing of a Conditional Binding Term Sheet for the Acquisition of Psilocybin-Based Drug Developer Clairvoyant

Press Release ↗

Psyence scoops up fellow psilocybin drug developer for just $500k upfront (paid in shares, no less). Clairvoyant, which is currently trialling a psilocybin-based candidate for alcohol use disorder in a Phase 2 study, also has the chance to earn two $250k milestones as part of the deal… but this is still a punishingly low valuation for a company that raised $3M in the heady days of 2021.

August 26 – September 1, 2024

Pα+ Psychedelic Bulletin #171

Psychedelic Alpha ↗

  • Lykos CEO Provides AdComm Feedback to FDA Commissioner
  • Cybin Plans to Fight Functional Unblinding with ‘Firewall’
  • Doblin Charts a Future for MAPS ‱ DEA Plots Ketamine Crackdown
  • Colorado Closes First Round of Rulemaking for State Psychedelics Program.
  • Other Stories, including: MindMed’s Phase 3 program; upcoming FDA-affiliated event on PTSD treatments.

August 19 – 25, 2024

August 12 – 18, 2024

Pα+ Psychedelic Bulletin #170

Psychedelic Alpha ↗

  • MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline?
  • atai Approaches Phase 2 for DMT and R-MDMA Candidates
  • Compass’ Phase 3 Program Generally On-Track, Potential for Slight Delay on Readout
  • European Psychiatrists Remain Open to Psychedelics, Research
  • Other Stories, including: Cybin’s Phase 3 plans; AbbVie’s $8.7bn neuropsych acquisition; Otsuka’s DTx pricing; Intra-Cellular Therapies’ preferred non-hallucinogenic lingo; Gilgamesh’s Fierce 15 spot; Incannex’s green light from FDA; and more.

Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind

Psychedelic Alpha ↗

Josh delves into FDA’s appeal process with regard to Lykos Therapeutics’ development program, and covers the trio of journal article retractions that have cast another shadow over the company’s published studies. Plus: We assess the fallout beyond Lykos, as psychedelic drug developers wrestle over the role of psychotherapy in their protocols, fast followers assess their strategies, and would-be psychedelic therapy delivery companies face a substantial delay.

August 5 – 11, 2024

Vibe Check: FDA Set to Decide Future of MDMA-Assisted Therapy This Week

Psychedelic Alpha ↗

With a target PDUFA date of August 11th, FDA is expected to make a decision on Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA) at some point this week.

As we brace for a deluge of mainstream media coverage and insider reactions, Josh takes the opportunity to provide a brief assortment of notes and thoughts.

Three Lykos-Affiliated Studies Retracted

↗

The journal Psychopharmacology has issued three retraction notices for MAPS/Lykos’ meta-analysis of phase 2 studies of MDMA-assisted therapy for PTSD, which constituted the rationale for a Phase 3 program. The first retraction pertains to the pooled analysis of the half-dozen phase 2 studies (Mithoefer et al., 2019), the second relates to the long-term follow-up of those six trials (Jerome et al., 2020), and the third applies to an analysis of four of the phase 2 studies to explore the effect of tapering antidepressants (Feduccia et al., 2020).

July 29 – August 4, 2024

July 21 – 27, 2024

Pα+ Psychedelic Bulletin #169

Psychedelic Alpha ↗

  • Sergey Brin Bets $15M on Ibogaine Startup Soneira, But Questions Loom Over Patents
  • Head-to-Head Trial Hopes to Assess Role of Psychotherapy in Psilocybin Treatment
  • J&J Seeks FDA Approval of Spravato as Monotherapy
  • Other Stories

July 16 – 21, 2024

Pα+ Psychedelic Bulletin #168

Psychedelic Alpha ↗

  • California’s Psychedelic Research Bottleneck Ends Today
  • Letter to the Editor: NeƟe Devenot
  • A Look at Complaints as Oregon Psilocybin Services Turns One
  • Disability and Psychedelics
  • Other Stories

July 8 – 15, 2024

Pα+ Psychedelic Bulletin #167

Psychedelic Alpha ↗

  • Lykos Insiders, Affiliates, Respond to Critics
  • Might FDA Miss Its August 11th Goal Date?
  • FDA-Affiliated Workshop Discusses Ketamine’s Use In Mental Health Treatment
  • Colorado’s Regulated Psychedelics System Takes Shape; Last Chance for Public Comment
  • EMA Reps Recap Psychedelics Workshop
  • Other Stories

Natural Medicine Advisory Bulletin 12: May and June 2024

Psychedelic Alpha ↗

Vicente LLP walk us through more than a dozen hearings, meetings and (proposed) rule updates since our last Bulletin. As we head into a month that features final public hearings on a number of matters, now is the time to make your voice heard.

July 1 – 7, 2024

Pα+ Psychedelic Bulletin #166

Psychedelic Alpha ↗

In this Issue:

  • Dan Crenshaw and Elon Musk Add Fuel to Lykos ‘Dumpster Fire’ Drama
  • ‘They Not Like Us’ — Psychedelic Drug Developers Emphasise Avoidance of Lykos’ Perceived Pitfalls
  • Mini Interview: Joshua Ismin, Psylo
  • Other Stories

June 24 – 30, 2024

Pα+ Psychedelic Bulletin #165:

Psychedelic Alpha ↗

  • A Closer Look at a Buzzy Oral Ketamine for Depression Study;
  • UN Weighs In on Psychedelics;
  • Another CA Psychedelics Bill Fails

and more…

Considering Alternatives to Psychedelic Drug Prohibition

RAND ↗

RAND has published a 161-page report on the state of non-medical psychedelic use in an effort to inform policymakers in the U.S. and beyond. Psychedelic Alpha is pleased to be cited as a source of data and analysis in the piece.

Oregon sued over access to magic mushrooms

Portland Business Journal ↗

“The plaintiffs are challenging OHA’s “failure to ensure” that the psilocybin program doesn’t discriminate against physically disabled individuals.”

June 17 – 23, 2024

June 10 – 16, 2024

Psychedelic Bulletin #164: Lykos Dominates News Cycle; EPIsoDE Trial Readout; EU Drug Report Discusses Psychedelics; DEA Should Improve RFRA Petition Process; Other News

Pα+ Psychedelic Bulletin #164:

Psychedelic Alpha ↗

  • Lykos Dominates News Cycle;
  • EPIsoDE Trial Readout;
  • EU Drug Report Discusses Psychedelics;
  • DEA Should Improve RFRA Petition Process;
  • Other News

June 3 – 9, 2024

May 27 – June 2, 2024

PTSD Has Surged Among College Students

NYT ↗

“The prevalence of post-traumatic stress disorder among college students rose to 7.5 percent in 2022, more than double the rate five years earlier, researchers found.”

May 20 – 26, 2024

Pα+ Psychedelic Patent Analysis: April 2024

Psychedelic Alpha ↗

This month:

  • A CaaMTech & ASRI Collaboration
  • GH Research & Beckley Psytech: An Update
  • CaaMTech Grows Tryptamine Patent Portfolio
  • Atai Sees Two New Allowances to Support DMT Program

May 13 – 19, 2024

Lucid News Salutes Our Friend Ken Jordan

Lucid News ↗

“The staff of Lucid News is deeply saddened by the death on Sunday of our friend and colleague Ken Jordan. In addition to being our Editorial Director and co-founder of Lucid News, Ken was a true pioneer and leader in the psychedelic movement and a dear friend to many of us. He had a clear vision of the future of psychedelic communities and dedicated his life to the transformative power of psychedelics for worldwide healing.”

We at Psychedelic Alpha share in this deep sadness. If you would like to honour Ken’s legacy, please consider donating to Lucid News.

Amazonian Chief At UN To Combat Traditional Knowledge Piracy

International Business Times ↗

“A psychoactive brew prepared from vines by the people of the western Amazon basin, ayahuasca is seen, depending on the version, as a miracle cure, a tool for inner exploration and personal development, a recreational hallucinogen, or a dangerous psychotropic drug.”

May 6 – 12, 2024

Welcome to the Age of Psychedelic Inequality

The Nation ↗

“Psychedelic-assisted therapies have been hailed as the wave of the future. They’re also becoming big business. What if most people can’t afford them?”

The State of Psychedelics

Oprah Daily ↗

“The idea that all of a sudden, wow, instead of having to take a pill every day, a single dose of psilocybin or MDMA could have this profound effect on a chronic illness—it’s pretty cool,” said former NIMH Director Thomas Insel.

April 29 – May 5, 2024

Rick Doblin Featured in TIME100 Health

TIME100 Health ↗

“I feel incredibly lucky to see the change that I’ve been working for happen in my own lifetime,” Doblin says. “I can die happy, whenever that comes around.”

$3.8 million to help Northern Rivers community heal after 2022 floods

Australian Minister for Health and Aged Care ↗

“The stepped care treatments in this clinical trial will include an arts-based group compassion program and group-based MDMA-assisted therapy. It is hoped the findings will provide additional treatment options for those impacted by future disasters.”

Bob Nelsen on megarounds, Altos and psychedelics

Fierce Biotech ↗

“Psychedelics are included, a field that Nelsen said ARCH has an interest in. He said that there’s more scientific rigor needed to really dig into how psychedelics work but that the mechanisms of action are intriguing.”

Pα+ Psychedelic Patent Analysis: March 2024

Psychedelic Alpha ↗

  • First Look at Nolan Williams et al.’s Ibogaine IP: Is Co-Administration of Magnesium and Ibogaine Common Practice?
  • Clexio Biosciences Protects CLE-100 Development Programs
  • Broad Strokes Attempt from Axsome Fails to Overcome Prior Art
  • NYU Abandons “Hot Psilocybin Patent Garbage”

A Path Toward Parity: Ensuring Equitable Access to Psychedelic-Assisted Therapy

BrainFutures ↗

BrainFutures’ latest report “focuses on the critical intersection between the Mental Health Parity and Addiction Equity Act (MHPAEA) and psychedelic-assisted therapy (PAT), offering insights into how this law can help pave the way for comprehensive insurance coverage and access to PAT for those who stand to benefit.”

April 22 – 28, 2024

Psychedelic drugs to treat eating disorders

UK Parliamentary Office of Science and Technology ↗

Two new Rapid Response briefings from the UK Parliament’s POST look at the state of the evidence for psychedelics’ use in treating PTSD and eating disorders.

April 15 – 21, 2024

GUEST WRITERS

↗

Are you interested in writing for Psychedelic Alpha? Please reach out to hello@psychedelicalpha.com with a short blurb about yourself, topics you might be interested in writing about, and any published work samples.

The Bad Trip Detective

Nautilus ↗

“[Jules] Evans doesn’t advocate against psychedelics. But by exposing the hazards that tripping could involve, Evans hopes to temper the prevalent ethos of breezy optimism with a dash of caution.”

April 8 – 14, 2024

Developing Esketamine (Spravato) and Lessons for Psychedelic Drug Developers with Jaskaran Singh

Developing Esketamine (Spravato) and Lessons for Psychedelic Drug Developers with Jaskaran Singh

Psychedelic Alpha ↗

Josh sits down with Jaskaran (‘Jaz’) Singh, Vice President Psychiatry Development at Neurocrine Biosciences. For the purposes of this conversation, however, we focus on Singh’s role in spearheading the development of esketamine for treatment-resistant depression, now marketed as Spravato.

Here, we discuss how Singh’s early work assessing ketamine’s antidepressant effects at the National Institute of Mental Health (NIMH) encouraged him to move into industry; how his team decided to pursue esketamine; lessons learned that might be relevant for psychedelic drug developers; and his broader outlook on the field.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Press Release ↗

The company’s pipeline includes SPT-348, “a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, [which] leverages Glyph to create a potential first-in-class treatment with improved pharmacokinetics and tolerability compared to conventional psychedelics.”

April 1st, 2024

April 1 – 7, 2024

MindMed’s ‘Total Elimination’ of Psychotherapy in LSD Study Stokes Debate Around Its Role in Psychedelic Therapies

Psychedelic Alpha ↗

In March, MindMed scored an FDA Breakthrough Therapy Designation for its LSD-D-tartrate candidate (MM120) for generalised anxiety disorder (GAD). In this piece, Josh takes a closer look at the company’s claim to have ‘eliminated’ psychotherapy from its Phase 2b study of MM120 and explores how a broader ‘Spravato-isation’ of psychedelic therapies is stoking debate around the contribution of psychotherapy (or lack thereof) in these interventions.

March 25 – 31, 2024

atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

Press Release ↗

According to the press release, a single dose of BPL-003 “demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12”.

It’s worth noting that the initial topline results represent 12 participants.

Beckley Psytech also published its own press release.

March 18 – 24, 2024

The psychedelic AI found

POLITICO ↗

POLITICO covers Mindstate Design Labs’ IND submission for a Phase I study of 5-MeO-MiPT.

March 11 – 17, 2024

March 4 – 10, 2024

FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder; Company Provides 12-Week Data and Fleshes Out Phase 3 Program Plans

Psychedelic Alpha ↗

Psychedelic drug developer MindMed has announced that the FDA has granted breakthrough therapy designation to its LSD-D-tartrate candidate (MM120) for the treatment of generalised anxiety disorder (GAD). The company also shared topline 12-week data from the same program, as well as results of a pharmacokinetic bridging study and further details on phase 3 study design.

Pα+ subscribers can read our coverage here.

Pα+ Psychedelic Bulletin #158

Psychedelic Alpha ↗

  • Fluence and UPRA Team Up to Bring Psychedelic Therapy Training to Ukraine
  • MindBio’s Small Open Label Microdosing Study Shows Promise in MDD
  • Biomind’s 5-MeO-DMT Study Shows Promise, But Small Sample and Unclear Protocol Temper Excitement
  • Oregon Psilocybin Services Complaints
  • Further Reading & Other Stories

Read the latest Issue.

Prominent At-Home Ketamine Co. Founder, Juan Pablo Cappello, Sounds Alarm, Withdraws Support for the Practice

Psychedelic Alpha ↗

One of the at-home ketamine industry’s biggest boosters has turned bearish, calling for caution among patients and providers and withdrawing his endorsement of the practice. Here, we take a closer look at the case study that changed Cappello’s mind as well as broader concerns around at-home ketamine operators, and we speak with Cappello himself.

atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01

Press Release ↗

Readers might remember that atai shared topline results from a Phase 1 study of the candidate back in October 2023, finding the oral transmucosal film (OTF) formulation to be “well-tolerated with a favorable safety profile”. However, the company announced it would “further optimize” the candidate in preparation for a Phase 2 study in treatment-resistant depression.

As such, this Phase 1b study will compare an improved OTF formulation of the candidate with IV. The improvements include taste masking, a backing layer, “and enhancements to further increase permeability.”

For reference, atai dosed the very first subject with VLS-01 in Q4 2022.

Vancouver to reinstate business licence of illegal magic mushroom dispensary

Vancouver Sun ↗

“At a business licence hearing Tuesday, a three-person panel approved a motion asking staff to reinstate the licence with terms that clarify the business is involved in education and advocacy of medicinal psychoactive substances.”

“We opened the door now, just a crack, but it’s only going to get bigger”, said Dana Larsen.

On March 7th, Vancouver Sun columnist Dan Fumano wrote a piece titled, “Dan Fumano: Psychedelics are illegal — and Vancouver police say criminal charges could be coming”.

February 26 – March 3, 2024

Incannex Announces Positive Topline Results from Phase 2 Psi-GAD1 Clinical Trial of Psilocybin in Generalised Anxiety Disorder

Press Release ↗

The Phase 2a study, which saw 73 GAD patients assigned to receive psilocybin-assisted therapy or placebo with psychotherapy, achieved its primary endpoint.

The sponsor, Incannex, is now preparing to test the intervention in a Phase 2b study. More coverage is available in Bulletin 157.

The study is featured in a new SBS documentary, too.

Separately, Incannex’s Chief Scientific Officer, Mark Bleackley, spoke with Pharmacy Times about psilocybin’s potential.

March 1-7, 2024

February 19 – 25, 2024

Ibogaine Advocates Seek Ohio Opioid Settlement Funds Following Failure in Kentucky

Psychedelic Alpha ↗

The loose coalition of ibogaine funding advocates—led by former Kentucky Opioid Abatement Advisory Commission Chairman Bryan Hubbard—has landed on a new state to house their project: Ohio.

In this article, we explore the magnitude of opioid settlement funds available in Ohio; the funding mechanisms we expect ibogaine advocates to tap in support of their renewed initiative; why advocates believe Ohio makes sense as a potential champion of this work; and, the challenges ahead for such an ambitious project.

February 12 – 18, 2024

Pα+: Dispatch from ‘Advancing Psychedelic Clinical Study Design’, Hosted by the Reagan-Udall Foundation for the FDA (Part 1)

Psychedelic Alpha ↗

Two weeks ago, the Reagan-Udall Foundation for the FDA hosted a two-day meeting, Advancing Psychedelic Clinical Study Design. It offered great insight into how academics, industry representatives, and—crucially—the FDA are viewing psychedelic drug development programs.

In this piece, Josh shares some key themes, analysis and take aways.

The Day 2 Dispatch is now available, too. It covers Set and Setting, FDA’s regulatory authority, and real-world use of psychedelics.

Natural Medicine Advisory Bulletin #8: January 2024

Psychedelic Alpha ↗

As Colorado’s Natural Medicine Advisory Board (NMAB) officially adopts an initial set of 123 recommendations, with many having dozens of sub-parts, Vicente LLP review the January 2024 meetings of the NMAB and its subcommittees.

February 1-7, 2024

January 1-7, 2024

December 11 – 17, 2023

Pα+ Psychedelic Bulletin #151: Psilocybin for BDII, ACNP Readouts, Methylone for PTSD, and More Psychedelic Drug Dev. News

Psychedelic Alpha ↗

Featured content in this Issue:

  • MAPS PBC Files New Drug Application for MDMA-Assisted Therapy for PTSD
  • Compass-Sponsored Study of Psilocybin in Bipolar Type II Finds Preliminary Safety and Efficacy, Potentially Warranting Larger Trial
  • MindMed Shares Topline Results from LSD for Generalised Anxiety Disorder Study
  • Clairvoyant Therapeutics Provides Update on Ph 2b Psilocybin for Alcohol Use Disorder Trial
  • Delix Provides A First Look at DLX-001 Phase I Data
  • Intra-Cellular Therapies Presents Preclinical Data from Non-Hallucinogenic Psychedelics Program
  • Gilgamesh Wraps Phase I Trial of GM-2505
  • Cybin Provides Further CYB003 Data
  • Transcend Provides First Look at Phase 2 Methylone for PTSD Data

Read Bulletin 151 now.

MAPS Public Benefit Corporation (MAPS PBC) has filed a New Drug Application (NDA) with FDA for MDMA-Assisted Therapy for PTSD.

Psychedelic Alpha ↗

MAPS Public Benefit Corporation (PBC) has submitted its New Drug Application (NDA) to the FDA in order to seek marketing approval of MDMA-assisted therapy (MDMA-AT) for PTSD.

The organisation and its parent non-profit, MAPS, has been conducting clinical studies of MDMA-AT for over twenty years, making this a significant milestone.

And it’s not just a milestone for MAPS: this is the first psychedelic-assisted therapy submitted to the FDA for approval.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD,” said MAPS PBC’s CEO, Amy Emerson.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health”, she continued.

More Coverage:

  • FDA to review MDMA-assisted therapy, a milestone for psychedelics (WaPo)
  • The US Is One Step Closer To MDMA Therapy (VICE)
  • FDA may review MDMA for the treatment of PTSD (CNN Health)
  • First-ever drug application for MDMA finally reaches FDA after near 40-year journey (Fierce Biotech)
  • FDA to consider psychedelic-assisted therapy for PTSD (The Hill)

DEA Again Moves to Place DOI and DOC in Schedule I of the Controlled Substances Act

Federal Register ↗

The agency withdrew its earlier effort to do so in August 2022, but noted it would be back with an amended procedure.

“Perhaps this withdrawal is the product of a procedural quirk as opposed to a change in attitude from the agency”, we wrote in Bulletin 116 back in August 2022.

It certainly seems so.

Comments close on January 12th, 2024.

One has to wonder whether proposing this rule over the holidays might reduce the likelihood of significant public and industry engagement, as seen in DEA’s first attempt to schedule these substances.

Comments may be submitted here.

In Memoriam: Roland R. Griffiths, Ph.D

Neuropsychopharmacology ↗

“Griffiths lived a remarkable and consequential life. As one young physician scientist said upon hearing of his death: he changed the world for the better.”

Reminder: Don’t Put Your Medical License At Risk

On Drugs ↗

“Bottom line: if you are a medical professional flirting with these new systems, be careful. Certainly, dial down blasĂ© echoing from the purveyors of the medical marijuana establishment. Get a robust and unbiased legal opinion. Don’t let someone shoot from the hip.”

AWESTRUCK

Johns Hopkins Magazines ↗

“The scientists plan to spend another year or so slipping the VR headset on patients dosed with psilocybin to learn what settings might dial up the awe of a psychedelic experience.”

December 4 – 10, 2023

Ex-Alaska Airlines pilot accused of trying to cut plane’s engines indicted on endangerment charges

Associated Press ↗

Attempted murder charges against a former pilot have been dropped. Instead, he now faces 83 reckless endangerment charges.

The off-duty pilot had consumed psilocybin mushrooms around 48 hours prior to attempting to cut the engines off during an Alaska Airlines flight.

“The attempted murder charges were never appropriate in this case because Captain Emerson never intended to hurt another person or put anyone at risk – he just wanted to return home to his wife and children,” his defense lawyers Ethan Levi, Noah Horst and Norah Van Dusen said in a statement. “Simply put: Captain Emerson thought he was in a dream.”

EVENT RECAP

reMind’s Psychedelics Business Forum

↗

We had a great time in Las Vegas at reMind’s second Psychedelics Business Forum, which brought together a diverse crowd to discuss the present and future of the psychedelics industry.

I (Josh) really enjoyed the focus on sharing practical tips for operators and the focus on what entrepreneurs and practitioners can do right now, or in the near future. This was a nice change from my usual beat, which is often focused on things like drug development that have long timelines.

It was great to moderate a couple of panels, too. I spoke with Courtney Barnes and Sam Chapman about psychedelic policy reforms, as well as Nykol Bailey Rice and Chris Walden about ketamine clinics. Having written quite a bit about both of these topics over the past few years, it was refreshing to hear from those with intimate, first-hand experience.
Josh Hardman

Having attented many psychedelic conferences in the past few years, I appreciated reMind’s focus on making plenty of space for networking in the program. Providing this scaffolding and drop-in networking space was especially helpful for people like me who simultaenously suffer from networking FOMO and networking burnout at conferences.

Josh Court Sam

Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes

JAMA ↗

This Compass Pathways-funded study evaluated a single dose of psilocybin with psychotherapy in 15 individuals with bipolar II depression.

“…most participants met remission criteria on the Montgomery-Åsberg Depression Rating Scale 3 weeks after a single 25-mg psilocybin dose, and most remained in remission 12 weeks postdose with no increase in mania/hypomania symptoms or suicidality.”

“The findings suggest efficacy and safety of psilocybin in bipolar II depression and support further study of psychedelics in this population.”

November 27 – December 3, 2023

Psychedelic Bulletin #150: Drug Development and Research Updates

Pα+ Psychedelic Bulletin #150: Drug Development and Research Updates

Psychedelic Alpha ↗

This Issue of the Bulletin primarily focuses on psychedelic drug development and business stories, with around 4,000 words of coverage and analysis.

Featured content in this Issue:

  • GH Research’s Lead 5-MeO-DMT Candidate Faces Development Hiccup, Potential Hold-Up
  • Psychae Therapeutics Scores AUD $4.5m to Develop DMT-Based Candidate
  • Cybin Closes $30m Offering
  • Brain & Behavior Research Foundation Awards Grants to 8 ‘Young Investigators’ Exploring Psychedelics
  • atai Buys Out Remainder of DemeRx’s Ibogaine Asset; Announces Novel 5-HT2A Agonist Candidates
  • Compass Pathways Commences UK Portion of Phase 3 Trial, Officially Opens Centre for Mental Health Research and Innovation in London
  • Awakn Plans to Commence Enrollment for Phase 3 Study of Ketamine for Severe Alcohol Use Disorder in Q1 2024

Read Bulletin 150.

UPCOMING EVENTS

↗

reMind Psychedelics Business Forum
28-29 November, Las Vegas, U.S. (info & tickets). Use Josh’s code for 20% off: REMJHARDMAN20.

Horizons NW
1-3 December, Portland, U.S. (info & tickets). Use PALPHA-NW-15 for 15% off.

Psychedelics and mental health (Seminar)
7 December, Imperial College London (Zoom registration)

Rapid-Acting Mental Health Treatment Summit
7 Jan, 2024, San Francisco, U.S. (info & tickets).

Leave No Drug Behind

Transform ↗

“Psychedelic drugs (or any drug), should not be treated as exceptional and more viable for decriminalisation or legal regulation simply because they are perceived to present lower risks than other drugs, be therapeutically more useful, or be somehow more spiritually significant.”

November 20 – 26, 2023

Pα+ Psychedelic Patent Analysis (October 2023)

Psychedelic Alpha ↗

Our monthly Psychedelic Patent Analysis provides headline figures regarding published psychedelic patent applications and grants, before diving into commentary on a select handful of patent-related actions.

This month:

  • MindMed Scores Psilocybin-Antidepressant Co-Treatment Patent
  • A Spate of PCTs Published from GH Research
  • Early Fruits of Cybin’s Small Pharma Acquisition

Note: the monthly Psychedelic Patent Analysis is a Pα+ subscriber benefit (join today). Given that this is a new format, we’re making this first issue available without a paywall.

Podcast: The Psychedelic Industry with Josh Hardman

Drug Science ↗

“In this episode, Josh Hardman, the founder of Psychedelic Alpha, explores the multitude of challenges currently being encountered by the psychedelic industry. He engages in discussions regarding the progress of decriminalisation and legalisation initiatives, upcoming clinical trial milestones, and delves into the current state and the potential evolution of the Psychedelic industry.”
Drug Science Josh Thumbnail

Plea for psychedelic rules reform

RACGP ↗

“A new coalition of healthcare professionals wants a review of ‘overly restrictive’ [psychedelics] prescribing guidelines, but a GP expert says changes must be done ‘slowly and carefully’.”

November 13 – 19, 2023

WEEKLY POLL

↗

You answered:

  • None: 37%
  • 1: 30%
  • 2: 26%
  • 3: 5%
  • More than 3: 2%

Psychedelic Bulletin #149: Worldwide Psychedelic Policy Developments

Pα+ Psychedelic Bulletin #149: Worldwide Psychedelic Policy Developments

Psychedelic Alpha ↗

This Issue of the Bulletin focuses on various policy-related developments that have materialised in the past few weeks. These include inaugural hearings in the U.S. House, subcommittee meetings and forums, as well as the publication of reports and key changes to major psychedelic policy reform efforts.

In this Issue:

  • TREAT Retreats
  • Wiener Regroups: Decrim. Off the Agenda
  • California Psilocybin Decrim. Initiative Continues Gathering Signatures
  • Veterans’ Affairs Subcommittee on Health Discusses Psychedelics
  • Canadian Senate’s Subcommittee on Veterans Affairs: “The Time is Now” to Fund Psychedelic-Assisted Therapy Research
  • Transform Publishes a “Practical Guide” to Regulating Psychedelics
  • UK Government Responds to Drugs Committee’s Report
  • More Policy News

Read the 5,000+ word Issue.

Colorado Natural Medicine Advisory Bulletin #5: October 2023

Psychedelic Alpha ↗

While some aspects of the Natural Medicine program, like cultivation and testing requirements, are more or less settled, the Board is still wrestling with some difficult questions.

The Board is attempting to strike a delicate balance between regulatory safety and program sustainability, a task that may turn out to be the most difficult one of all.

Read the latest via our Bulletin, written by Jeff Fitzgerald and Vicente LLP.

VA “committed” to studying psychedelics for PTSD

Axios ↗

“Based on our assessment of the literature to date, there is still much to learn, and much yet to be understood, about the potential benefits of psychedelic compounds. Our department is not only focused on finding the best innovative treatments and cures but doing so safely.” – VA assistant undersecretary for health, Carolyn Clancy

Regarding MAPS’ Phase 3 program, Clancy suggested the VA’s main concerns are related to a relatively small sample size and even smaller number of veterans included.

Library: Psychedelic REMS

Pα+ Library: Psychedelic REMS

Psychedelic Alpha ↗

Here, we sketch out what a psychedelic Risk Evaluation and Mitigation Strategy (REMS) might look like, which should go some way to highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

How to Regulate Psychedelics

Transform Drug Policy Foundation ↗

Transform’s Practical Guide is now available to download. Consider ordering a hard copy to support their work.

Magic mushrooms and the mind

The Week ↗

“A growing number of states and cities are legalizing the use of psychedelic fungi in therapy. Some experts think that’s a big risk.”

November 6 – 12, 2023

WEEKLY POLL RESULTS

↗

We Asked: In 2033, this molecule will have approvals for the most indications in the U.S.:

You answered:

  • MDMA (48%)
  • Psilocybin (44%)
  • LSD (4%)
  • DMT (0%)
  • Other (4%

Cybin Announces up to US$64 Million Offering of Units

Press Release ↗

The company announces “a firm commitment underwritten offering” of around 67 million units at a price $0.45 per unit for gross proceeds of $30m. Up to an additional $34m could be raised if warrants (priced at $0.51) are exercised.

Psychedelics Will Help America’s Mental Health Crisis — If the FDA Lets Them

American Institute for Economic Research ↗

The AIER, a ‘conservative and libertarian free-market think tank’ published a short article on psychedelics for mental health illness.

The bent of the article is that “it’s time for the FDA to decide” whether to ‘generate an approval process for psychedelics.” But this seems to hinge on a misunderstanding of FDA’s draft guidance on clinical investigations involving psychedelics which does not seek to establish a separate approval pathway for psychedelics.

Why We Need to Regulate Psychedelics

Transform ↗

“This is an edited extract from Transform’s How to Regulate Psychedelics: A Practical Guide – by Steve Rolles and Ester KincovĂĄ – now available to buy in print. This will be published on Nov 14th! Register for the launch webinar here.”

October 30 – Nov 5, 2023

Psychedelic Bulletin #148 (Pα+)

Psychedelic Alpha ↗

This is the first issue of our Psychedelic Bulletin that’s exclusively for Pα+ subscribers. Head to our Join page to learn more.

This issue’s contents:

  • Notes from the Conference Call: Cybin’s Deuterated Psilocybin Analog Results
  • Federal Appeals Court Throws Lifeline to Psilocybin Rescheduling Effort
  • UK Report on Barriers to Research with Controlled Drugs Expected to Publish Soon
  • Meta Ignores its Oversight Board’s Suggestions Regarding Ketamine Ads
  • ‘Mushroom Pilot’ Case Sparks Soul-Searching
  • Leading UK Psychedelic Drug Policy Reform Group Rebrands, Founder Mired by Arrest
  • NIH to Establish and Fund a National Cannabis Research Centre
  • New NIDA Grant Opportunity for Psychedelics
  • Ethics Approval for Study of Psychedelics in Romantic Relationships
  • Other Headlines & Weekend Reads

Cybin Announces Unprecedented Positive Phase 2 Interim Data for CYB003 in Major Depressive Disorder Meeting Primary Efficacy Endpoint with Rapid and Significant Improvements in Depression Symptoms After Single Dose

Press Release ↗

Pα Take: It’s worth stressing once again that this is a small N study, and today’s interim data reflects a subset of that already-small N. Nonetheless, the data appear positive, with a substantial mean MADRS score reduction and safety profile that gives other psychedelic candidates a real run for their money. It now remains to be seen whether these results are reflected in the full Phase 2a data and ultimately sustained in a larger Phase 3 program. With plans to commence a Phase 3 program as early as Q1 2024, along with a Phase 2 study of its CYB004 deuterated DMT candidate for generalised anxiety disorder, it’s going to be a busy couple of quarters for Cybin staff and investigators! ∎  ↗ Psychedelic Alpha

Photo shows vehicle crashed into ‘Shroomyz’ shop in Toronto
 again

↗

There’s little information about the Friday morning incident: chiefly, whether it’s an accidental car crash or intentional ram-raid (or a pure act of malice, etc.).

Remember that, because they’re operating outside of the law, stores like Shroomyz are often relying on cash for transactions.

The neighbouring store, which has been forced to close, wrote on Instagram that “someone drove their truck into [Shroomyz…] for what I’m sure are some pretty nefarious reasons.”

The striking image was posted by u/Key-Suggestion-1377 on the Toronto subreddit, and is now reported in a number of local outlets.

It’s not the first time this has happened. Back in September, a car was crashed into another Shroomyz store on Dunlop Street West just after midnight on a Wednesday.

Based on images, the crash wasn’t quite as destructive as yesterday’s RAM truck.

WEEKLY POLL RESULTS

↗

We Asked: Do you consider ketamine a psychedelic?

You answered:

  • Yes (43%)
  • No (36%)
  • Not sure (21%)

Psychedelic Summer School! (UvA, June 2024)

UvA Summer School ↗

Christian Greer and Erik Davis are running a two-week summer school intensive at University of Amsterdam next year. The Psychedelic Universe: Global Perspectives on Higher Consciousness will provide “an in-depth exploration of psychedelic consciousness across space, time, and culture”.

Vancouver police bust three storefronts selling psilocybin and psychedelics

Vancouver Sun ↗

“Longtime pot activist Dana Larsen opened the stores on East Hastings, West Broadway and Granville street starting in 2019”

“Larsen claims his operations are “under attack by the city,” and is urging supporters to attend a public hearing about the business licences on Dec. 6 at city hall.”

Over in California, Bakersfield man arrested in illegal marijuana dispensary bust on California Avenue: BPD (Oct 31) ↗ Bakersfield Now

SCHOLARSHIPS

Usona Institute ↗

Usona Institute’s scholarship program supports practitioners seeking training or certification in psychedelic-assisted therapy and emerging scholars engaged in post-graduate degree programs focusing on psychedelics.

Breakthrough antidepressants with fewer side effects could help millions of Americans. Here’s what the future of treatment may look like

Fortune ↗

“Products in the works at various pharmaceutical companies aim to make ketamine and other dissociative drugs, such as psychedelics like MDMA, even better antidepressants. Some drugs combine ketamine with other medicines to extend its efficacy and reduce the need for such frequent doctor visits. Other research explores ways to cut the hallucinogenic effects from ketamine and psychedelics while holding onto the antidepressant effects.”

TREAT California Withdraws 2024 Ballot Initiative Efforts

Statement (PDF) ↗

TREAT California, which had hoped to make its way onto the state’s 2024 ballot and ultimately convince voters to endorse a $5bn psychedelic R&D institute, has withdrawn the project.

In a statement, the organisation said that while voters “have expressed widespread support for the initiative’s objectives”, polling “indicates they do not yet believe in creating a state agency to fund the program.”

Polling conducted by FM3 Research revealed striking political cleavages (which we discussed in Bulletin 147), with the average Californian independent or Republican opposing the measure.

The group announced a newly-formed nonprofit, TREAT Humanity.

October 23 – 29, 2023

WEEKLY POLL RESULTS

↗

We Asked: When will MDMA-assisted therapy be approved by FDA?

You Answered:

  • First half of 2024 (11%)
  • Second half of 2024 (50%)
  • 2025+ (33%)
  • Not sure (6%)

Beckey Waves Acquires Nue Life

Beckley Waves ↗

Beckley Waves co-founder Daniel Love will act as interim CEO of NueCo Holdings PBC, a newly-formed company that will acquire the assets of Nue Life Health Inc.

A New Era of Psychedelics in Oregon

NYT ↗

“The state has pioneered a therapeutic market for psychedelic mushrooms. Researchers are watching with a mix of excitement and unease.”

What’s behind ketamine, the drug of the decade

EL PAÍS ↗

“Consumption of this substance has reached its highest point since 2017 and is leaving a mark on popular culture. Some defend its therapeutic power, but others warn of its destructive potential”

October 16 – 22, 2023

Psychedelic Bulletin #147

Psychedelic Alpha ↗

  • đŸš« Analysis: California Governor Vetoes Psychedelic Decrim. Bill
  • 🚹 At-Home Ketamine Gets Another Lifeline, But FDA Sounds Alarm
  • ⚖ One to Watch: Challenge to Chevron Could Shatter Federal Agencies’ Power
  • 📊 Bionomics’ Phase 2b Study of PTSD Treatment Reports Positive Results
  • 🏅 Fabre-Kramer’s 5-HT1A Agonist Scores FDA Approval for MDD After Multiple Rejections
  • 📰 Psychedelic Drug Development Updates (GH Research; atai; Cybin)

and lots more.

Dr. Roland Griffiths Passes Away

↗

On Monday evening Roland Griffiths, a pioneer in psychedelic and consciousness research, passed away.

Professor David Nutt shared:

A sad day: my longtime friend and colleague Roland Griffiths died last night after a long battle with cancer during which he showed the inspiring courage and wisdom that characterised his whole career, especially in resurrecting psychedelic research. A truly great scientist.

An interview between Roland and his wife, Marla, and Manish Agrawal displays the pair’s remarkable sense of perspective on Roland’s diagnosis and beyond.

Beyond his immense impact on the present field of psychedelic and consciousness research, his legacy includes The Roland R. Griffiths, PhD, Professorship Fund in Psychedelic Research on Secular Spirituality and Well Being. The Fund establishes (and aims to support, in perpetuity) a world-class psychedelic research program to advance human flourishing and wellbeing.

The ↗ New York Times remembered Griffiths in an article that charts his contributions.

…as did the ↗ Baltimore Banner.

↗ Johns Hopkins shared a tribute to Griffiths, too, which noted that the endowment is at $24 million.

Diamond Therapeutics Announces First Patient Enrolled in FDA-authorized Study Evaluating Low-Dose Psilocybin in Human Subjects with Demoralization

Press Release ↗

Announces First Patient Enrolled in FDA-authorized Study Evaluating Low-Dose Psilocybin in Human Subjects with Demoralization (Oct 17) ↗ Press Release

The trial hopes to enrol 60 patients to evaluate low-dose psilocybin in demoralisation (which includes feelings of hopelessness and meaninglessness). Diamond does not expect the doses to produce subjective effects.

Pα: Given the dearth of clinical trials evaluating ‘microdosing’, and the equivocal nature of observational studies regarding the practice’s effects (or lackthereof), this should be an interesting study to follow (speaking of which, here’s the trial registry entry: NCT05227742). However, it is worth pointing out that the trial’s dosing protocol – which sees five drug (or placebo) administrations over as many weeks – is dissimilar to popular microdosing regiments. ∎

Spravato Sales Reached $183m in Q3

J&J ↗

Johnson and Johnson’s Q3 2023 results show $183 million in worldwide sales (the vast majority of which were in the U.S.) of Spravato in Q3 2023 vs. $100 million in Q3 2022.

Harvard launches new Study of Psychedelics in Society and Culture

The Harvard Gazette ↗

A gift from the Gracias Family Foundation supports the launch of an interdisciplinary effort across the Faculty of Arts and Sciences, Harvard Law School, and Harvard Divinity School.

Quartz also covered the news: A former Tesla director is giving Harvard $16 million to study psychedelics in society and culture

Mario Can’t Be Super Without Psychedelic Power-Ups

NY Times ↗

“Now there’s Super Mario Bros. Wonder, which turns the franchise into a carnival of bizarre delights. Each level includes a wonder flower, a new mechanic that sends Mario on something like a psychedelic trip, reconfiguring the world around him — warp pipes start crawling like caterpillars, rhinos begin a stampede and some mountains gain a set of googly eyes.”

October 9 – 15, 2023

WEEKLY POLL Results

↗

Q: Should Governor Newsom have signed SB-58 to decriminalise certain psychedelics in California?

A: Unsurprisingly, the ayes have it! 80% of you voted yes, with just 5% voting no. 15% of you sat on the fence, answering not sure.

Natural Medicine Advisory Bulletin #4: September 2023

Pα X Vicente LLP ↗

“Coming into the sixth month of work, Colorado’s regulated natural medicine program is starting to take shape”, writes Jeff Fitzgerald of Vicente LLP for the latest update from the state’s Natural Medicine Advisory Board.

MDMA-assisted psychotherapy for PTSD in adolescents: rationale, potential, risks, and considerations

European Child & Adolescent Psychiatry ↗

While comments on ‘giving MDMA to kids’ have caused some hoopla on the conference circuit, if MDMA-assisted therapy is approved in adults then exploring it in adolescents may be the next step on the clinical research agenda. Two researchers published a review article on the topic today, Tuesday 10th (they published a preprint in the Summer).

See our earlier coverage of MDMA-AT’s potential pediatric studies.

Johns Hopkins Group Eyes TV Reboot to Capture the Wonder of Science

JHU Hub ↗

JHU is exploring a reboot of its postwar science TV show, “The Johns Hopkins Science Review”, on a platform like Netflix, and psychedelic research could get airtime: “Psilocybin research and the groundbreaking work of the School of Medicine’s Center for Psychedelic and Consciousness Research is another topic of interest”, the article notes.

God, Magic Mushrooms, and Me

Esquire ↗

“There’s a growing movement among religious leaders to use psychedelics like psilocybin to deepen their faith. The author attended a secret ceremony to find out whether it works.”

California Gov. Gavin Newsom vetoes bill that would have decriminalized psychedelic mushrooms

AP News ↗

Pα: (We will be covering this more extensively in a forthcoming Bulletin – sign up today.) The Governor’s veto is not entirely surprising, given Newsom’s rumoured national political ambitions. Newsom’s associated letter (which is not something a Governor has to accompany a veto with) doesn’t slam the door closed on psychedelic policy reform, either. But it’s clear Newsom would like to see something more closely focused on ‘therapeutic use’, though the term is admittedly vague. Expect to see Sen. Wiener return next year with a new Bill. Our Editor-at-Large Graham Pechenik and I (Josh Hardman) spoke to Wired about the news. ∎
Video Thumbnail

Psychedelics Prove Popular at ECNP

ECNP’s Tweet ↗

“Psychedelics are hot in the field of mental health!”, Tweeted the European College of Neuropsychopharmacology alongside a photo of a packed conference hall.

Pα: Our own Josh Hardman attended ECNP’s New Frontiers meeting in France earlier this year, which was entirely dedicated to psychedelics (read our write-up). It’s great to see this interest borne out at the main conference, too. ∎

Psychedelic health claims may be promoting risky self-medication

New Scientist ↗

“Drugs such as psilocybin can trigger dangerous psychotic experiences and should only be used with medical supervision, warns psychiatrist Jonathan Iliff at New Scientist Live”

Pα: A number of researchers that work with psychedelics have shared concerns around topics like decriminalisation and ‘self-medication’ of late. In response to a WaPo Opinion piece titled “Self-medication with psychedelic drugs is a dangerous plan”, Robin Carhart-Harris said, “I tend to agree”. Jennifer Mitchell, meanwhile, told the LA Times she was against California’s decrim. bill. ∎

The Big Money Behind Kentucky AG Daniel Cameron’s Bizarre Psychedelic Drug Crusade

Daily Beast ↗

Is ibogaine R&D an appropriate use of the state’s Opioid Abatement Advisory Commission funds? A $42m grant would be its biggest to date, by a long shot.

Cameron’s ibogaine initiative “came out of the blue” and “caught everybody off-guard”, according to a source in a Daily Beast exclusive, which alleges conflicts of interest.

Pα: Just as psychedelic advocates question Newsom’s motives for vetoing SB 58, this reporting questions the motives behind KY’s potential ibogaine funding. Opposition researchers have requested ibogaine program-related records from Cameron’s office, so there may be more to come. ∎
SVG Image

Filament Health Receives Health Canada Authorisation for Ph 2 Psilocybin Trial

Press Release ↗

Health Canada has given the go-ahead for a Filament-sponsored study of psilocybin for the treatment of opioid use disorder. The Phase 2 trial will take place at University of British Columbia

Pα: In a crowded synthetic psilocybin drug development space, Filament is looking to differentiate itself by using a ‘botanical’ psilocybin candidate. ∎

Case Report: Fungal Infection in Lungs Following Psilocybin Use

Chest Journal ↗

The case report details how a 49 year old immunocompromised male ended up with a fungal infection in his lungs.

The patient explained that he had cultivated his own psilocybin mushrooms and turned them into a powder using an electric coffee grinder.

NYT profiles the Athenaeum

NY Times ↗

“…just three blocks from Grand Central Terminal, tucked within the sprawl of advertising offices, finance firms and chain stores, a community center dedicated to consciousness-altering substances has taken root.”

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