Welcome to Our 200th Psychedelic Bulletin!
We published our first Psychedelic Bulletin in October 2020, half a year after Psychedelic Alpha was founded. What started as a brief rundown of the week’s news has become a mostly-weekly report on key news, data, and insights from across the field of psychedelic industry, policy, and science.
We launched our paid subscription offering, Pα+, in November 2023, meaning the vast majority of Bulletins since then have been reserved for our Pα+ subscribers. That means they’re more detailed than ever. While Bulletin 100 came in at around 1,000 words, our average Pα+ Bulletin is in the region of 3,000 words.
To celebrate our 200th Bulletin, we’re making this jam-packed edition free to read.
Before we get into this issue, we’re looking back at the stories covered in Bulletin 100 and seeing where they are now…
The Class of Bulletin 100: Where Are They Now?
Bulletin 100, published in April 2022, featured a handful of stories.
We reported that Terran Biosciences had licensed two late-stage CNS assets from big pharma company Sanofi. That came shortly after it bought some CNS assets from Concert Pharmaceuticals. Terran was keeping a very low profile at the time, but had boasted of its psychedelics patent portfolio as early as March 2022, telling reporters that it had “more than 150 patents in psychedelic therapeutics”.
As Terran’s psychedelics IP strategy became clear, we covered it in drips and drabs over the years. Our magnum opus on that particular topic, however, was Noah Smith’s 7,000-word investigation into the company’s strategy, published in July 2023.
Elsewhere in Bulletin 100, we briefly covered Nue Life Health’s $23M Series A financing, which we described as “whopping” and noted that it came less than a year after its $3.3M seed round.
The round, led by Obvious Ventures, demonstrated “some level of investor confidence in the at-home ketamine therapy space, despite a range of recent reporting on concerns surrounding the niche”, we wrote at the time.
Since then, the discussion (or, debate) around at-home ketamine businesses has intensified, as has the market. Mindbloom has emerged as perhaps the most commercially successful yet controversial such business (see Ketamine on the Edge), with others including Joyous and Innerwell. More recently, companies like Noma Therapy have emerged, hoping to offer a more supportive at-home ketamine treatment protocol.
The industry has also suffered regulatory uncertainty, with FDA issuing warnings about compounded ketamine for psychiatric disorders, and PR crises including the drug’s implication Matthew Perry’s death. (As we note later, Mindbloom is suing the Wall Street Journal for defamation, as it claims the outlet linked it to Perry’s death.)
For Nue Life, however, the road travelled since that $23M Series A has been tumultuous, culminating in the company being sold for parts to Beckley Waves, as we reported in November 2023 (see A Nue Lease of Life? Beckley Waves Acquires Struggling At-Home Ketamine Provider Nue Life Health).
What’s more, its co-founder, Juan Pablo Cappello, has gone from leading the at-home ketamine charge to becoming one of the industry’s most vocal critics (see Prominent At-Home Ketamine Co. Founder, Juan Pablo Cappello, Sounds Alarm, Withdraws Support for the Practice).
Elsewhere, we covered Olivia Goldhill’s STAT reporting that covered a lawsuit filed in May 2021 alleging a MAPS board member had exploited her relationship with an elderly psychedelics advocate. The article detailed a complaint brought by George Sarlo’s family, which alleged that Vicky Dulai had “exploited her relationship with Sarlo to take more than $4 million from him.”
Dulai remains Board Chair at MAPS and will interview British actor Esmé Bianco on stage in Denver later this month at the nonprofit’s Psychedelic Science conference. Her LinkedIn profile describes her role as a “Psychedelic Philanthropic Consultant” at MAPS.
Other headlines we covered included Mindset Pharma’s filing of a provisional patent application covering next-gen DMT and 5-MeO-DMT candidates. In August 2023, Mindset was acquired by Otsuka in an all-cash transaction valued at around $60M.
As you can see from the small set of stories covered in Bulletin 100 alone, so much has changed in the past few years since that issue.
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Can Czechia Deliver on Psilocybin Access and Provide a Model for the Continent?
The Czech Republic’s Chamber of Deputies—the lower house of the country’s Parliament—has voted to pass sweeping reforms to the European nation’s criminal code that generally aim to reduce the prison population and focus more on fines versus custodial sentences.
Of the 159 MPs present, 142 voted in favour of the reforms, meaning just 16 actively opposed the measures (all hailing from SPD, a right-wing populist party) and one abstention.
Justice Minister Pavel Blažek, who has stepped down after becoming embroiled in a Bitcoin scandal whereby his office accepted a €40 million bitcoin donation from convicted darknet drug market operator Tomáš Jiřikovský, hoped the reforms would bring the penal system more up to date and in line with EU standards.
While the headline changes in the bill include an easing of cannabis laws (allowing for cultivation of up to three cannabis plants for personal use and the possession of up to 100 grams of dried cannabis at home or 25 grams in public), one psilocybin-related change was inserted.
The psilocybin-related amendment, forwarded by MP Marek Benda, contemplates the legalisation of psilocybin’s use as a medicine in certain contexts. (View a machine-translated copy of the amendment here: PDF.)
The amendment broadly allows for psilocybin to be used ‘in limited therapeutic purposes in psychiatric hospitals under the direct jurisdiction of the Ministry of Health and in psychiatric outpatient or inpatient facilities that are part of those hospitals, by a physician with specialised qualifications in the field of psychiatry or medical psychotherapy.’ For healthcare facilities that are not under the direct jurisdiction of the health ministry, a treatment permit may be sought.
Interestingly, the text of the amendment contemplates certain physicians (to be decided upon through government regulation) being able to prescribe the drug, but only certain healthcare professionals, like psychiatrists, permitted to administer it. That could allow, for example, a palliative care doctor to prescribe psilocybin, which would then be administered by a psychiatrist.
According to the present language, psilocybin ‘may only be administered in justified cases to a patient over 18 years of age’, and its administration ‘is guided by the clinical recommended procedure for assisted psychotherapy with psilocybin for therapeutic use.’
In terms of how such use must be supervised, the text says that such supervision ‘includes repeated monitoring of the mental state and vital functions’ during the session. The administering physician must keep a record ‘of the course of each individual session’ for at least ten years.
Physicians who are found in breach of these rules will generally face a fine of up to CZK 500,000 ($23,000).
In his commentary on the amendment, Benda suggested that psilocybin prescriptions might be requested by qualified physicians via a ‘blue-stripe’ prescription form, which is a special type of prescription reserved for more tightly-regulated medicines, like addictive or psychotropic ones, in Czechia.
But many of the specifics will be determined by the Government at a later date, by way of regulations. That is expected to include:
- The conditions for which psilocybin can be used.
- Limits on quantities that can be dispensed over a given period of time.
- Requirements around specialised competencies of those involved in the delivery of psilocybin.
Next Steps
The bill now heads to the Senate, where those close to the action believe it will pass.
According to Psyres, a Czech psychedelic research and advocacy group, 68% of Czechs think that psychedelics should be used medically if a patient and their doctor agree to it. The survey, conducted by Simply5 in February 2025 with a representative sample of just over 1,000 Czechs, also showed a lack of familiarity with the class of drugs, with a significant portion of respondents having no real awareness of the topic. Nonetheless, views on medical use were broadly positive.
Proponents of the amendment are presumably hoping this public and MP support will only buoy their case. “Given the overwhelming support in the Chamber of Deputies, I hope it’s high”, lobbyist Viktor Chvátal said when we asked him to give a percentage likelihood of its passage. “However, politics is politics and uncertainty is the core principle of living”, he added.
Advocates that Psychedelic Alpha spoke with could not answer how long it might take for people to be able to access psilocybin treatment if the amendments are signed into law.
Tempering Expectations: Lessons from Psilocybin Access Experiments
While some have touted the potential legal change as a potential breakthrough for the 700,000 patients with depression and anxiety in the country, it’s unclear whether any meaningful portion of those would receive access to the drug.
Benda’s amendment specifically references Oregon and Australia’s efforts to set up psilocybin access in its justification for the proposed changes, stating explicitly: “The amendment is inspired by these foreign regulations.”
But experiences in Australia, Switzerland, and Canada—all of which have mechanisms for accessing psilocybin and/or other psychedelics pre-approval—might be cause for tempering expectations around the scale of potential patient access.
As we covered last week, data obtained by Psychedelic Alpha reveals that fewer than 100 patients accessed psychedelics through Australia’s limited rescheduling pathway in its first 18 months of operation. In Switzerland, meanwhile, just shy of 700 patients accessed MDMA, LSD or psilocybin in 2024, a number which has grown consistently year-on-year over the past decade or so. And, in Canada, throughout the first 1,000 or so days of its Special Access Program accepting applications for psilocybin and MDMA, just 318 applications were approved.
But advocates told Psychedelic Alpha that they believe the Australian system is built to scale, in time. Aussie health insurer Medibank Private, for example, is funding an MDMA-assisted therapy study, and the country’s Department of Veterans’ Affairs is also funding studies of psilocybin and MDMA. That work could lead to new models, or new reimbursement pathways, that broaden access down under.
Chris Raine, who worked on implementing the country’s psychedelic-assisted therapy infrastructure, has suggested that the slow roll-out is a feature, not a bug, which “protects against the risk of commercial interests creating ‘pill mills’” and ensures “those delivering care will be held to the highest standards”. He believes that, within the next decade, tens of thousands of patients will receive treatment through the system.
Ted Cassidy, meanwhile, who is thought to have handled the first psychedelic prescription in the country via his Monarch Mental Health Group, said the limiting factor is “good therapists”. He added that each psychedelic-assisted therapy patient receives around 80-100 hours of therapy as part of the package.
“Over the last 18 months Monarch Mental Health Group treated about 30 of those first 100 PAT patients”, he said, “by contrast, we treated 1,000 patients with TMS and 100-200 with Spravato/esketamine.” “My point is that PAT does not stand alone”, he continued, “but [is] part of a treatment algorithm for TRD and PTSD where simpler, easier, cheaper and yes ‘more scalable’ treatments are tried first.”
It will also be interesting to see how the Czech psychiatric establishment responds to the potential establishment of a psilocybin treatment pathway prior to a conventional approval. Regular readers might remember that many Australian psychiatrists, including the Royal Australian and New Zealand College of Psychiatrists, were caught off-guard by the country’s limited rescheduling.
In a recent episode of that organisation’s podcast, Psych Matters, guests emphasised that they were taken by surprise by the decision, and that they did not—and still do not, to some extent—believe there was or is enough research on how to safely and effectively deliver psychedelics to people with mental health disorders. Professor David Castle said that the data is encouraging, but “very, very limited”, especially on matters like who shouldn’t be a candidate for psychedelic therapy, how many doses are optimal, certain safety data, and so on.
They described it as ‘somewhat premature’, and said that patients, too, were unsure what to expect from it. (Dr Diana Korevaar, for example, said that patients often expect it to be a passive process where they are healed by the drug, especially if they are coming from standard therapy, as opposed to a more involved one.)
The psychiatrists speaking on the podcasts also emphasised just how unaffordable the therapy is, with a price tag of around $25,000 AUD ($16,250). It’s looking like it could become “just another rich medicine”, Castle added.
Professor Colleen Loo, meanwhile, urged patients to seek the advice of an independent psychiatrist before seeking out psilocybin therapy for depression, warning against turning up at a specialty clinic, which she argued has an incentive to qualify you for the treatment as opposed to taking a more holistic view of other modalities and potential treatments.
In Oregon, the model has not only priced out many would-be psilocybin services clients, it’s also made it tricky for psilocybin service providers to survive.
Still, advocates insist they are building a ‘Czech model’ of psilocybin access that is not beholden to the models employed elsewhere. Some of those individuals also told Psychedelic Alpha that they believe this is a foot in the door, which could allow for broader access in time, as more scalable, resource-efficient models that maintain care are devised.
Chvatal, meanwhile, was more frank: “I am a lobbyist,” he told us, “not a public health expert or therapist.” He considers the changes to be, “a strategic and incremental step within the margins of politically possible.”
A Czech Model for Europe?
In the U.S., there is an idea that its system of fifty states are each ‘laboratories of democracy’, where individual states can pursue distinct policy agendas that might lead to learnings for other states, or the federal government.
Indeed, psychedelics are featuring heavily on that front, with states like Oregon, Colorado, and New Mexico all advancing psychedelic access programs without relying on FDA approvals. Other states, of course, have passed their own flavours of psychedelics-focused policy reforms, too.
While the term is most commonly used to refer to the states, might countries like Czechia show that EU member states can also act as laboratories of democracy when it comes to psychedelic policy reform?
“It’s super encouraging to see Czechia taking a lead in Europe”, Tadeusz Hawrot, founder of PAREA told us. “For progress to happen at EU level, we need member states to lead, and this kind of national initiative can provide both political weight and practical insights.”
Beyond this specific amendment, Chvatal and co. are hoping that the Czech Republic will play an important role in addressing deteriorating mental health among Ukrainians.
“In a nutshell,” Chvatal told us, “we want to position the Czech Republic as an EU Member State that has an ambition to help Ukraine with mental health reconstruction in coordination with other EU institutions.” (A conference being hosted at Prague Castle, the President’s residence, next Monday will continue that discussion. Our Editor, Josh Hardman, will be in attendance and speaking.)
Czechia’s Psychedelic Legacy Comes Full Circle
When it comes to being a leader in access to psychedelic therapies, Czechia might be a natural candidate.
In 1960s Czechoslovakia, pioneers of LSD treatments for psychiatric issues included Milan Hausner and Stan Grof, a rich history charted in beautiful detail by Ross Crockford. Grof eventually made his way to the U.S., landing at Johns Hopkins University, one of the many modern-day psychedelics research centres.
While that mid-Century LSD work stalled by the 1970s, the country has exhibited glimmers of a more progressive attitude to drug policy. With the fall of the communist regime in late 1989, for example, the country reworked its criminal code to decriminalise the possession of illicit drugs for personal use. While personal use-related drug offences were again tagged with criminal penalties in the late ‘90s, they were again removed after a study found that they did not impact drug use. In 2013, the country allowed cannabis to be used as a medicine, seven years before the UN Commission on Narcotics reclassified the drug. (As mentioned by Benda.) All in all, the approach has been deemed as somewhat more rational than other countries, with Open Society Foundations describing it as ‘smart and humane’ in a 2012 article.
Back to the topic of psychedelics, Czech researchers and practitioners have shown interest in studying and rolling out access in recent years.
The country’s early embrace of ketamine-assisted psychotherapy (KAP), for example, is a case in point. While American readers might be familiar with ketamine clinics, they are a rare sight on the European landscape.
Psyon, a clinic based in Prague, began offering KAP in late 2020. Remarkably, the company has been able to strike a deal with certain health insurers in Czechia, roughly halving the cost of treatment. Still, the treatment is pricey, with an initial KAP session with one therapist present coming in at between 14,200 and 19,700 crowns for those with relevant insurance ($650-$900), and 29,500-39,700 crowns for those paying privately ($1,357-$1,800).
But Psyon’s model is, admittedly, much more involved than the average U.S. provider, which often hooks a patient up to an IV and leaves them be. The combination of the pharmacological agent and the psychotherapy is central to their offering, the company suggests.
The fact that payors, including some of the country’s largest health insurance companies, are willing to partially reimburse ketamine-assisted psychotherapy increases the legitimacy of psychedelic therapies among government stakeholders, advocates have said.
Aside from being a leader in providing partially-reimbursed KAP on the continent, Psyon is also one of six Czech sites for Compass Pathways’ Phase 3 study of COMP360 psilocybin (NCT05711940).
Elsewhere, Tomáš Páleníček’s Psychedelic Research Center at the National Institute of Mental Health in Klacany, just north of Prague, has a healthy portfolio of psychedelic research projects underway.
With a clear lineage of LSD mid-Century LSD research through to today’s ketamine-assisted psychotherapy and psychedelics research work, Czechia might have been primed for the present amendments to its criminal code.
Beyond researchers and practitioners, Chvatal told us that the proposed changes are the product of a long-term effort by philanthropists, advocates, and groups like Psyres. “In my opinion, we have witnessed a combination of both bottom-up awareness raising as well as top-down political negotiating with very senior stakeholders on both sides involved”, he said.
Chvatal believes that a focus on the practical issues around psilocybin therapy, such as cost effectiveness, “made it easier for authorities to engage.”
Could Countries Like Czechia Challenge Psychedelic Pharma’s Playbook?
It will be curious to see if for-profit psychedelic drug developers, like Compass Pathways, react at all to this development.
Indeed, in Marek Benda’s discussion of the proposed changes detailed in his amendment, he writes: “The reason for submitting this amendment is the fact that scientific studies show that psilocybin has very good results in the treatment of psychiatric illnesses”. The one study he cites? Compass Phase 2b trial of COMP360 psilocybin in treatment-resistant depression (Goodwin et al., 2022).
While Compass has kept shtum on this particular issue, some psychedelics industry insiders are vocally against the move. Christian Angermayer, co-founder and chairman of atai Life Sciences, wrote on Twitter: “All these grassroots initiatives don’t really work”, adding: “It’s the same story in the Netherlands and other countries.”
“What the world truly needs are psychedelics that are fully medical: FDA-approved, pharmaceutical-grade, administered by your local doctor, and covered by health insurance”, he continued.
Indeed, the cost of accessing psychedelics through any of the existing legal pathways—from Oregon’s psilocybin services through to Australia’s limited rescheduling—is prohibitive for the vast majority of patients, meaning the carrot of potential payor reimbursement is dangled by drug developers as the reason for their marketing authorisation efforts. (Or, it’s used as a fig leaf to cover what some believe to be their immodesty—a desire to enjoy a monopoly on marketing psychedelics in the event of an approval.)
Should the Czech Republic succeed in creating a more accessible model, it could directly challenge the commercial strategies of psychedelic drug developers. Czechia is a small market for pharmaceuticals, meaning it is unlikely to cause any real concern to psychedelic drug developers on its own. If, as some advocates hope, it begins to inspire similar moves in more profitable markets, that calculus might shift.
For now, however, the contours of the country’s potential psilocybin access system remain underdeveloped, meaning there is no reason just yet to believe that it will be so.
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In the first instance, it remains to be seen whether the Senate will give its own nod to the proposed amendments. If the amendments do become law, all eyes will then be on whether the Czech Republic can succeed in delivering a scalable access pathway to psilocybin, ahead of any EMA approval.
As our Editor sets off to Prague tomorrow, you can be sure this is a story we are following very closely!
A Closer Look at atai’s Potential Acquisition of Beckley Psytech
As we reported on Monday, atai Life Sciences has inked a deal with Beckley Psytech that would see it acquire the private British psychedelic biotech in an all-share transaction that values the company at around $370M.
Importantly, the terms are structured in a way that gives atai the option to back out of the transaction, should Beckley’s imminent Phase 2b study of intranasal 5-MeO-DMT (BPL-003) in treatment-resistant depression (TRD) not deliver.
For a thorough look at the deal based on discussions with insiders, and a review of the competitive landscape, see our original coverage: atai Moves to Acquire Beckley, If Phase 2b 5-MeO-DMT Data Delivers.
Shares in atai have continued ripping upwards since then, up around 10% on the week and 70% on the month.
Since that coverage, we have had time to mull over an SEC filing associated with the proposed transaction, as well as the concurrent $30M PIPE financing by Ferring Ventures and Adage Capital Partners.
That document provides a closer look at the ‘certain milestones’ that Beckley’s Phase 2b readout must meet in order to avoid atai backing out of the purchase. Those Phase 2b success criteria are as follows:
- Statistical significance must be achieved on the primary endpoint, MADRS change at week 4, with a p<0.05.
- There must be 3 or fewer individual cases of drug-related serious adverse events in the 8 mg arm.
- There must be less than a total of 6% drug-related serious adverse events observed in the 12 mg arm.
(The verbiage also suggests that those are the specific ‘medium’ and ‘high’ doses employed in the study.)
Should these conditions not be met, atai can pay a break fee of $4M to Beckley, in cash or shares, and sink the deal.
Since our Monday coverage we have also had time to speak with insiders about the news. Investors seem generally enthused. Some expressed excitement around what they believe might be a return of M&A activity in the space, with this deal marking the first of its kind for quite some time.
But some in the field have communicated concern at atai’s acquisition. Those people generally expressed a belief that Beckley Psytech’s ethos is not aligned with that of atai. Some of these people said that they had been relieved to see a potent psychedelic drug like 5-MeO-DMT developed under the tutelage of Beckley, which they perceived to be a more ‘psychedelic-informed’ crowd, and are now concerned that atai’s more substantial involvement could somehow change the spirit of the development effort.
We have also reviewed materials describing the deal, which show that the new C-Suite team will retain Srini Rao as CEO, with Beckley CEO Cosmo Feilding Mellen assuming the role of Chief Strategy Officer. Beckley’s Rob Conley will take the role of Chief R&D Officer, while atai’s CFO Anne Johnson will retain her role, as will atai CMO Kevin Craig, CSO Glenn Short, and COO Gerd Kochendoerfer.
A leaked slide from an investor presentation projects atai Beckley’s valuation following certain potential milestones. Between the announcement and closing of the deal, the slide suggests that certain potential catalysts—the deal announcement, BPL-003 Phase 2b readout, COMP360 Phase 3 readout, and a financing event—could see the combined company’s valuation rocket to $1.6 billion by the time of its anticipated VLS-01 Phase 2 readout in Q1’2026.
Q1’25 Psychedelic Lobbying Update
Each quarter, we provide a look at federal lobbying disclosures by psychedelic drug developers and nonprofits. That data is a lagging indicator, especially as filings are not required immediately at the end of each quarter.
Here’s a review of Q1 2025 activity…
Drug Developers: MindMed Leads Record Quarter for Federal Lobbying Spend
Disclosed federal lobbying activity among psychedelic drug developers has hit an all-time high, with four companies funnelling $300,000 into the effort last quarter.
The most significant jump comes from MindMed, which has launched a Phase 3 program studying its LSD candidate (MM120) in generalised anxiety disorder (GAD) and major depressive disorder (MDD). The company’s spend has leapt from $60k in Q4’24 to $100k in Q1’25. Compare this also to the combined spend across the first three quarters of 2024, $45k. That reveals a substantial increase in spending since the new administration took office.
According to its filings, MindMed is looking to lobby the Senate and House of Representatives on topics related to “mental health”, “FDA/DEA communication on controlled substances”, as well as “VA funding for operational infrastructure for mental health care.” It’s also engaged in “education and advocacy for novel brain health treatments.”
Otsuka maintained its $50k spend on lobbying related to “Research, development, and reimbursement of psychedelics for mental health conditions”.
Compass Pathways also held steady, again disclosing $60k in federal lobbying spend, the same figure it’s filed since Q1’24. It continues to push for “Funding for research on psychedelic drugs.” As we have covered previously, a substantial portion of Compass’ lobbying effort is taking place at the state level, where it has backed rescheduling trigger law bills that could see its drug come to market faster in certain states, and has opposed state-regulated psilocybin access systems.
Lykos Therapeutics has again reduced its federal lobbying spend to $90k, down from $110k in Q4’24 and a peak of $160k in Q3’24, around the time of the FDA’s decision on its MDMA new drug application (NDA).
Nonprofits: Lobbying Spend Settles to 2023 Levels
On the nonprofit side, the story is quite different, with filings showing a continued drop-off in disclosed federal lobbying spend, returning to Q3’23 type levels.
Of the handful of nonprofits that had been active in such efforts over the past year or so, only three disclosed federal lobbying spend in Q1’25: Reason for Hope, the Veteran Mental Health Leadership Coalition (VMHLC), and BrainFutures.
Reason for Hope and VMHLC spent the same sum that had been disclosed in the prior two quarters: $30k and $15k, respectively. The pair of organisations continue their focus on “Issues related to psychedelics research and psychedelic-assisted therapy”, and dropped language around their support for the Breakthrough Therapies Act that had been mentioned in previous disclosures. Those bills (H.R.1393 and S.689) were introduced in 2023 but made little progress.
BrainFutures again allocated $40k to their efforts, as in Q4’24. The organisation, which has engaged Hooper, Lundy & Bookman, disclosed that it is lobbying on “Issues related to a pathway for FDA approval of psychedelic drugs and therapies, issues related to reducing barriers to research and increasing federal funding of clinical research trials for psychedelic drugs and therapies; Issues related to medical adoption of and access to psychedelic drugs and therapies; S. 331 – HALT Fentanyl Act, provisions related to research.” In previous filings, the organisation had also lobbied for the Breakthrough Therapies Act, but has joined others in dropping that language since the bills festered.
A comparative look shows that psychedelics-focused nonprofits have continued to decrease their spend on federal lobbying, while psychedelic drug developers ramp up slightly.
As we have noted several times, the dollar spend reflected in federal lobbying disclosures does not capture the full extent of lobbying activity by psychedelics-focused organisations and their backers.
Obviously, it does not reflect activity at the state level, but there’s also the matter of realpolitik: lobbying is a soft power sport, with less formal lawmaker education projects or even outright schmoozing not always captured in the record.
Take Lykos, for example. While it has cut back its federal lobbying spend, at least one of its new investors, Antonio Gracias, has close ties to the government via Elon Musk. (Though, as this piece goes to press, it is clear that the Musk-Trump bromance has descended into an all-out feud.)
atai, meanwhile, hasn’t disclosed any federal lobbying spend since Q2’22, but its co-founder Christian Angermayer and investor Peter Thiel have expressed support for the Trump administration, even as the former told us he does not want psychedelics to become politicised.
And, Cybin has never spent any money, according to filings, on federal lobbying, making it an outlier among for-profit psychedelic drug developers with Phase 3 programs underway. Its CEO, Doug Drysdale, has flattered members of the new administration on social media and in interviews, however, and boasted of meeting with HHS Secretary RFK Jr. earlier this year.
On the nonprofit front, it seems clear that a flurry of activity in Q3 last year was an abnormality; a spurt of lobbying cash that sought to spur the approval of Lykos’ MDMA for PTSD new drug application from affiliated or like-minded groups.
While federal lobbying by psychedelic drug developers hit an all-time high last quarter, it’s important to acknowledge that the numbers remain modest, at least compared to what we might expect of more conventional pharma companies.
Other Stories
Holy Trips and Hot Takes: Religious Leaders Study Finally Published
Late last week, the religious leaders study finally published in Psychedelic Medicine (Griffiths et al., 2025). The publication of the study, which saw 24 psychedelic-naïve clergy from several religions dosed twice with psilocybin, was at one point uncertain and the subject of some level of controversy.
In terms of its key findings, the study reports:
- Most rated at least one psilocybin session among the top five most spiritually significant of their lives.
- At 16-month follow-up, most reported lasting positive effects on both their religious practices and their daily sense of the sacred.
- Nearly half also described the experience as among the top five most psychologically challenging of their lives.
- No serious adverse events were reported.
The findings were mostly met with a ‘meh’ by those within the psychedelics bubble, perhaps mainly because its publication was scooped by Michael Pollan’s New Yorker piece.
Reactions to the study have ranged from excitement to sarcasm. On the latter end of that scale is Jules Evans, writing on Twitter: “It turns out if you give psychedelics to priests who volunteered for a psychedelic trial, they have religious experiences…” Well, he is a Brit… what do you expect!?
Popular comments on New Yorker’s Instagram post that shares snippets from Pollan’s article include one from Paul Simon’s son, Harper: “And they didn’t toss their organized religion in the dustbin?”
Other commenters alluded to a potential opening of a joke: “A priest, a rabbi and a Zen Buddhist walk into a magic mushroom study”. (The ‘walked into a bar’ “almost writes itself”, Pollan himself acknowledged in his piece.)
Other popular comments cringed at Hunt Priest’s quotes in the New Yorker article, with one reading “More patriarchy” and another asking if women participated in the study. (The publication discloses that 33% of the 24 participants who received both doses were female, i.e. 8 participants.)
On the r/Christianity subreddit, meanwhile, the article received a modest 18 comments, all of which were positive or neutral. One user, Hazarbeard, said: “Mushrooms and robotripping softened my heart and opened my mind enough for me to finally let Christ into both.” Comments on the article in the r/Jewish subreddit were similarly positive.
New Guidelines Aim to Standardise ‘Set and Setting’ Reporting in Psychedelic Research
Researchers from McGill and Exeter University led an international Delphi consensus study that culminated in the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) 2025 Guidelines.
The recommendations, published in Nature Medicine, represent insights from 89 experts from 17 countries, including psychedelic researchers, clinicians, and past trial participants.
The Guidelines aim to encourage clinical psychedelics projects to use the standardised framework to report on contextual variables in studies, from the physical environment (ambience, lighting, bathroom facilities, and so on) through to the dosing session procedures, therapeutic framework, and subjective experience like therapeutic alliance and trust.
Exeter University’s press office described the publication as “the first global agreement on which psychosocial factors have the greatest impact on a psychedelic experience”, adding that the overall aim for the 30-item checklist is “to become the standard in the field and encourage the reporting of contextual factors in future studies.”
More Headlines
Mindbloom Sues WSJ. At-home ketamine company Mindbloom has filed a defamation suit against The Wall Street Journal, it said in a statement. The lawsuit concerns an August 2024 article that was published on the back of Mindbloom’s decision to add an injectable ketamine offering. Mindbloom argues that the article “falsely blamed Mindbloom in the death of actor Matthew Perry”. The lawsuit claims that the Journal “sensationalized risk, trafficked in fear, and portrayed mental health treatment in a way that reinforces harmful misconceptions.” The company also said that the article “blunted” its “rapid growth” trajectory, causing a “slide” in its new customer acquisition “resulting in a halving in net new client sales, and total net sales down a quarter, with no rebound to date.” The company added that customer acquisition costs rose. Mindbloom is seeking, among other things, damages for “lost profits of not less than $4,000,000”, “lost enterprise value of not less than $35,000,000”, and “expenses incurred combatting The Journal’s libels of not less than $350,000.”
HHS FY2026 Budget Published. The U.S. Department of Health & Human Services (HHS) has published its FY2026 Budget in Brief document (PDF). Three large mental health and substance abuse programs will be rolled into one Behavioral Health Innovation Block Grant, the budget notes.
Startup Licenses Rights to JHU Psilocybin Stroke Study IP. Rose Hill Life Sciences has licensed certain intellectual property related to a Johns Hopkins study that will investigate whether psilocybin-induced neuroplasticity can improve motor function among stroke patients, according to a press release. More information on the JHU project, PHATHOM, can be found here.
PharmAla to Publish MDMA Investigator’s Brochure on MAPS Website. MDMA research and supply company PharmAla has granted MAPS “authorization to post the PharmAla LaNeo MDMA Investigator’s Brochure (IB) publicly on the MAPS website”, a press release states. MAPS founder Rick Doblin described the move as “a model for the industry” and “a major contribution to researchers all over the world.” The company added that the IB “remains the sole copyrighted work of PharmAla Biotech, all rights reserved.”
Lawsuit to Compel Oregon to Allow In-Home Psilocybin Services Proceeds. A lawsuit against the Oregon Health Authority that seeks to allow disabled and terminally ill people to receive psilocybin services at their homes will proceed. As Oregon Live reports, a U.S. District Judge has denied the state’s motion to dismiss the suit. The state made some interesting arguments in attempting to have the case thrown out, arguing that a federal judge cannot compel OHA to allow in-home psilocybin use because it would violate federal law and the Controlled Substances Act. But the judge has ruled that Oregon state law might need tweaking in order to see it comply with the Americans with Disabilities Act, for example.
Dan Grossman Leaves PSFC Staff, Joins Board. PSFC’s Head of Field Building, Dan Grossman, who joined the group in late 2023 after Rick Doblin and David Bronner came across ‘a certain BCG guy’, is stepping out of his staff role at the organisation. He now joins the board, where he hopes he will have greater influence on the group’s strategic direction.
What the British Public Wants from Psychedelic Research. In a manuscript written by Maria Bălăeţ, the neuroscientist explores public priorities in psychedelic research, based on conversations she has had with the general public in the course of giving talks across the UK. While not systematic, the topics raised are indicative of what some (perhaps more psychedelics-curious) corners of the British public are intrigued by. The most frequently discussed topic, according to Bălăeţ, was the effect of psychedelics on people with autism spectrum disorder. Other topics included the potential role of psychedelics in ageing and neurodegenerative diseases, microdosing for cognitive enhancement, psychedelics for pain management, and long-term psychosis risks. The short manuscript is well worth a read for researchers and funders who wish to propose and support psychedelic research that chimes with public priorities.
“I am NOT taking drugs!” Musk Responds to Ketamine, Psychedelics Use Allegations. A much-discussed NYT feature claims that Musk regularly took ketamine (to the point it was “affecting his bladder) as well as “ecstasy and psychedelic mushrooms.” Musk has denied the reporting. “I am NOT taking drugs!”, he wrote on Twitter, adding: “The New York Times was lying their ass off.”
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