The Psychedelic News Feed

In this episode of The Psychedelic News Feed podcast, Psychedelic Alpha’s editor Josh Hardman runs through the last two weeks in the psychedelics field, including these stories:
  • Usona Institute files its psilocybin for major depressive disorder new drug application with FDA
  • FDA approves NRx Pharmaceuticals’ preservative-free generic ketamine
  • We share our analysis of 610 public comments on FDA’s psychedelics docket
  • ICER is set to review Compass Pathways’ psilocybin for treatment-resistant depression
  • More takeaways from The Psychedelic Healthcare Forum
  • Other stories

Read more:

The Psychedelic News Feed is published by Psychedelic Alpha and airs every two weeks.

This episode of The Psychedelic News Feed is supported by UBC. As psychedelic therapies move toward potential approvals, UBC helps sponsors navigate the evidence generation, pharmacovigilance, and comprehensive risk management strategies that support a path forward grounded in patient safety. Learn more at ubc.com.

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Creators and Guests

Host
Josh Hardman
Founder, Psychedelic Alpha

What is The Psychedelic News Feed?

The Psychedelic News Feed is the audio edition of Psychedelic Alpha's regular news roundup, bringing you a concise update from the worlds of psychedelic drug development, policy, and access.

In it, Psychedelic Alpha Editor Josh Hardman provides a brief review of happenings across the field.

Josh Hardman:

Welcome to the Psychedelic News Feed, a podcast from Psychedelic Alpha. Each episode brings you up to speed with the latest across psychedelic drug development, policy and access from around the world. It's presented by me, Josh Hardman, Psychedelic Alpha's founder and editor. These are intended to be concise summaries as opposed to deep dives. If you are looking for more nuanced analysis, exclusive interviews and unrivaled reporting on these topics and much more, head to psychedelicalpha.com.

Josh Hardman:

Welcome to the fourth episode of the Psychedelic News Feed podcast covering the period October 19 through November 1. We've got plenty to share today based on our reporting over the last two weeks, including our story that Usona Institute has filed its psilocybin new drug application for the treatment of major depressive disorder with the FDA. We have also covered FDA's approval just last week of NRx Pharmaceuticals preservative free ketamine. We also share our analysis of over 600 public comments that landed on the FDA's Psychedelic's docket. We look at how ISA, the healthcare cost effectiveness watchdog of sorts, is set to review Compass Pathways psilocybin for treatment resistant depression package, and we share some more takeaways from our Psychedelic Healthcare Forum that we hosted with Horizons in New York City last month before diving into some other stories.

Josh Hardman:

So let's get into it. This episode of the Psychedelic News Feed is supported by UBC. As psychedelic therapies move toward potential approvals, UBC helps sponsors navigate the evidence generation, pharmacovigilance, and comprehensive risk management strategies that support a path forward grounded in patient safety. Learn more at ubc.com. So a headline story which actually publishes today is that Usona Institute, the nonprofit psychedelic research organization, has completed its submission of a new drug application, an NDA, to the US Food and Drug Administration, the FDA, for its psilocybin candidate in major depressive disorder.

Josh Hardman:

At least that's what we understand according to sources close to the matter who spoke to Psychedelic Alpha on condition of anonymity. That would make it the second psychedelic NDA under review at present by FDA after Resilient Pharmaceuticals, which was formerly Lycos Therapeutics, and before that, MAPS PBC refiled its MDMA for PTSD application in the summer. Like Compass Pathways, a for profit psilocybin drug developer, Usona holds a Commissioner's National Priority Voucher, a CNPV, which aims to see the FDA make a decision within a couple of months after accepting the filing. So if the most optimistic timelines hold, there could be a decision in the coming weeks and certainly months. We understand that FDA has inspected several Usona trial sites as well as its headquarters in Wisconsin, and that Usona is now responding to agency questions and working on its REMS, which is the risk evaluation and mitigation strategies that would accompany any psychedelic approval by FDA.

Josh Hardman:

So this is fascinating. I think many listeners and readers will be surprised to learn that Usona may have even beat Compass Pathways to filing the full submission of a new drug application concerning psilocybin. But we have been, you know, sort of guiding this for quite some time, certainly since late last year. Last week, Usona hosted a summit at its headquarters, its remarkable headquarters, which I've been lucky to visit, incredible facility in Fitchburg just outside of Madison, Wisconsin. They hosted that meeting last Wednesday, and it was attended by many of the psychedelic drug developers I hear, including Compass, but also AbbVie, Otsuka, and others.

Josh Hardman:

Usona hosted the event. It didn't say anything about its program. Really, though, from what I understand, no updates. More, it sort of provided a forum for others to share, and there were federal agency representatives there, care delivery representatives, some researchers, and so on. So really discussing the rollout related topics.

Josh Hardman:

So we do know that Compass Pathways is still guiding that it plans to submit its own complete new drug application this quarter, and the company will be making its business update this week. So that's one to watch. So if Usona has submitted just before Compass, it could give it a slight edge in the race towards approval that Compass may still hold some advantages when it comes to launching. Compass certainly has a larger sort of commercial team, Salesforce, and and marketing capacity, and it does have a a larger dataset, of course. But still, Usona as a nonprofit would be a bit of a thorny competitor for Compass.

Josh Hardman:

Usona would be on label presumably for major depressive disorder, which is a broader population, encompasses treatment resistant depression. Both companies are pursuing full new drug applications, five zero five b one pathway applications as they're known in the FDA lingo. So neither of them would be able to block one another at the FDA as they would be able to if it was a sort of generic or a five zero five p two applicant. So, really, any competition and contest would be in the realm of patents and commercial execution. But if Usona were able to navigate around Compass's patents and were able to come to market in a meaningful way, that could be a real headache for Compass given that Usona, a nonprofit, would likely look to price its psilocybin well below the roughly 17 to $22,000 per dose that we estimate Compass could charge.

Josh Hardman:

So this is a fascinating moment for both Usona and Compass. I think many investors in Compass are quite confident in its patents and its ability to enforce those, one might presume. But maybe some of them are also underestimating Usona. So that might be the key question, whether Compass are able to exclude Usona from the market. Otherwise, things could get very interesting.

Josh Hardman:

So for much, much more, you can read our article out today. That's Monday, November 2 at psychedelicalpha.com. Sticking with the theme of FDA approval and review, on Friday, NRx Pharmaceuticals as ketamine drug developer announced that FDA has approved its abbreviated new drug application, an ANDA, for what it was calling Ketaphree, which is a preservative free generic ketamine product. I spoke with the CEO, Jonathan Javitt, last week to learn a little more. The drug is a generic, as I said, so it has the same label as Ketamine, which was the first ketamine product approved by FDA back in 1970, which means it's on label for anesthesia only.

Josh Hardman:

The real sort of differentiating factor of this product is that it doesn't contain a preservative, which is called benzathonium chloride or BZT, which virtually all commercially available formulations of IV ketamine at least in The US contain. Now NRx has gone on this interesting strategy of not only trying to get their preservative free ketamine approved, which they've now done, but also trying to lobby FDA to push all preservative containing formulations of ketamine off the market. Now they sought to do this through a citizen petition submitted to FDA last year, but the agency has yet to respond. So some providers, particularly those working in ketamine clinics or or offering ketamine for psychiatric purposes, are worried that this could cause a squeeze on supply if NRx are successful in pushing others off the market. But to be clear, that hasn't happened yet.

Josh Hardman:

And the company's claims themselves might warrant a little bit of scrutiny, and and we did quite a long article on this on Friday looking at their claims that BZT is toxic. So the safety case against BZT is a little bit sketchy. I mean, there's no definitive evidence, sort of pharmacovigilance evidence, for example, that people taking ketamine regularly do experience harms directly from BZT, and there's very little in the way of looking at the types of BZT exposure from psychiatric type dosing, which is obviously what our readers are mostly interested in. The company has also described the product as the sort of first preservative free ketamine formulation and has said that it's American made. Well, we went a little deeper on that, and Baxter Healthcare did win approval for a preservative free ketamine in The US in September 2025.

Josh Hardman:

And the actual ketamine ingredient, the active pharmaceutical ingredient in NRx's product is imported. It's made abroad with just the vials being filled and finished in South Carolina. So maybe a few questions hanging over some of those claims. And with no exclusivity and no ability to make comparative safety claims, pricing of its product, at least for now, whilst preservative containing forms of ketamine are allowed to remain on the market, will presumably follow the generic market for ketamine, which is measured in dollars per dose or dollars per vial. Now NRx's stock price slumped in response to the news.

Josh Hardman:

Many investors probably more interested in NRx 100, a separate program around that preservative free IV ketamine for which the company plans a new drug application in depression and suicidality. It's seeking to leverage real world data and real world evidence and license some data from places like France to get that on label. Now that could be a little bit more useful because it could allow clinicians and providers and patients to seek reimbursement from insurance companies and health care payers for generic ketamine for depression and suicide allergy, and therefore could offer an alternative, at least in the ketamine world, to spravato. Now last episode, we said that our review of FDA's Psychedelic's Docket was on its way, and that was published last Monday. So there were 610 submissions with just under 500 of those being distinct or unique, and a 100 of them were template style forms from different campaigns and and 14 duplicates.

Josh Hardman:

And of those submissions that took a position on psychedelics, on psychedelics potential use in the medical system, 94% were at least somewhat supportive. So predominantly positive valence of these submissions, at least in aggregate. Now the main fault lines were perhaps unsurprising to listeners here. The first was psychotherapy and whether it should be viewed as an integral part of the delivery of psychedelics in the medical system. Now industry had a clear position with groups like Definium Therapeutics and the Association for Prescription Psychedelics, which represents several drug developers in the field, and Eli Lilly suggesting that it should be optional and not part of the core model, while groups like MAPS and its founder, Rick Dublin, as well as the American Psychological Association wanting to see it as something more built into the protocols.

Josh Hardman:

Another area of discussion among submitters were trial era safeguards. So whether the sorts of regulations and requirements built into trials predominantly through FDA's draft guidance and now finalized guidance for psychedelic developers and sponsors, whether those employed in phase three studies should be mirrored in the real world. So Rick Doblin, actually, the founder of MAP, says that any conditions on approval should mirror phase three studies until companies produce data that says otherwise. A group of researchers at Oxford and Johns Hopkins who are focused on ethics proposed a sort of safety floor, which should be perhaps somewhat stringent and then relaxed one safeguard at a time as data allow. Now the Association for Prescription Psychedelics, which, as I say, represents several of the drug sponsors that says the trial protocol shouldn't automatically become permanent conditions.

Josh Hardman:

And lastly, another sort of area of much debate is around who is in the room when psychedelics are being dosed. So some people said that the two monitor per patient requirement that's often used in studies should be upheld. So, again, Dublin from MAPS, but also public citizen, sort of nonpublic citizen, which is a consumer advocacy group advocated for that position, whereas others advocated for a more risk based staffing model. So submissions from Cleveland Clinic, Eli Lilly on Usona, hoarding that argument. And others still sort of push for less labor intense models and and maybe even group models.

Josh Hardman:

So Odyssey, which provides psilocybin services in state regulated models, suggested that one licensed professional per three participants could be feasible and safe or at least worth exploring. There were a few particularly interesting comments. Aside from those main themes, there was one anonymous commenter who purported to have trained hundreds of dosing session monitors for psychedelic drug developers trials, and they urged FDA not to take sponsors' descriptions of in trial psychological support at face value. They said that they think that sponsors might be misrepresenting what is going on in trials. Another submission from CJ Healy questioned in a similar manner the external validity of psychedelic trials and asked whether plans for real world implementation truly reflect clinical conditions used in trials.

Josh Hardman:

It did appear that there was agreement elsewhere, though, many submissions saying that they believe there shouldn't be a class wide risk evaluation and mitigation strategies, so REMS. Others agreed that there should be attention given to reimbursement and trying to ensure that there's coverage where it is provided for the full course of care rather than just the drug product itself. Others agreed that there should be competency based credentials and that there should be registries with common data elements. Now in terms of the opposition, there were 45 comment, but most of those appeared to be a coordinated template letter. But there were some interesting submissions, at least one, a submission from former attorney general Ed Meese, who served under Ronald Reagan.

Josh Hardman:

And he said that premature legalization of these drugs can be very dangerous and even disastrous to our country. Now a couple of things to note. Of course, the FDA does not have the remit to legalize drugs. And also the comment by the former US attorney general was submitted as it carries a date of 06/01/2026, which is a month or so before FDA actually announced the public comments. So a little bit strange there.

Josh Hardman:

And there were also submissions from a group associated with the Church of Scientology, which is known for having a sort of anti psychiatry stance. So as I say, predominantly positive submissions. I'm not sure there's anything really new here, but we await to see if and how FDA digests this feedback and how it reflects it in its practices or guidances. On October 21, the Institute for Clinical and Economic Review, known as ISA, said that it will assess Compass Pathways psilocybin for treatment resistant depression package. Now ICER is a nonprofit that assesses the cost effectiveness of new health care treatments and interventions, and its reviews are pretty influential with insurance companies and others who pay for health care services in The US.

Josh Hardman:

So this would be the second psychedelic that ICER has assessed. In June 2024, quite infamously now, it concluded that the evidence on MDMA for PTSD was insufficient to determine benefit, and that review was shared quite widely, including that headline sort of finding, and it was mentioned as well at FDA's advisory committee later that year. And, obviously, MDMA went on to be rejected by the FDA in August 2024. For now, ISO has just published its scoping document, outlines how it might conduct the review, and comments on that scoping document are open until November 10. So time for any of you listening to get a word in there.

Josh Hardman:

For context, Compass is benchmarking its price against Bravato. As we said earlier in this episode, that comes out to roughly 17,000 to $22,000 per dose. And anyone interested in this particular topic might be interested in going back and looking at ICER's review of Johnson and Johnson's Esketamine nasal spray, which was in 2019 and, I think, again, in 2020. So worth a look there if you're particularly interested here.

Josh Hardman:

Our latest write up from the Psychedelic Healthcare Forum that we hosted last month in New York City covers the sort of capital and drug development side of the agenda. I think the common thread between all of those was that risk has moved downstream from questions around safety and efficacy now more towards things like REMS and reimbursement rollout related questions. On our investment panel, we heard from Ritu Baral at TD Cowen, Edni Inui at Palo Santo, Connor Williams at RTW Investments, and the panel was moderated by Madison Mueller at Bloomberg. Ritu Baral said that the questions she's had in 2018 were around efficacy, around how FDA would interpret the data and commercialization have now been knocked down one by one, she said, leaving remaining questions around things like reimbursement and how this will fit into the sort of health care system from an operational point of view. Now Connor Williams, RTW, he sort of named the REMS as perhaps the biggest remaining risk for companies that are coming up for FDA review.

Josh Hardman:

He worried that one that's too restrictive could massively cut down, he said, provided capacity. Elsewhere, these investors highlighted that the entrance of pharma into the field could be a positive in terms of expanding the sort of indications or conditions that the drugs are targeting given that those firms have a lot more financial firepower than sort of startups that are yet to have drugs brought to market. We then heard from a panel of drug developers, including Dan Karlin from Definium, AJ Cannon from AbbVie, and Srini Rao from AtaiBeckley, now part of Eli Lilly, of course. And that was moderated by Kyle LaHucik at Endpoints News. There, AJ Cannon sort of emphasized that AbbVie is looking beyond major depressive disorder for its bretsilosin candidate that it acquired from Gilgamesh, including perhaps PTSD.

Josh Hardman:

Srini Rao at Lilly said that Spravato has really sort of validated the interventional psychiatry model, which short directing drugs perhaps like the company's five MEO DMT and DMT candidates. And Dan Karlin sort of argued in a more philosophical sense as he is often won't to do that sort of dimensional flattening, he called it, in the field that treats psychedelics as one class is perhaps ill advised and said that we should look at each of these drugs on their own merits and with their own sort of profiles. He also said towards the end of the remarks in that session that politics shouldn't infringe on the science, and that if there were optics that it had done so, that would not be a good thing. You can read much more coverage from the forum, including on these topics over at psychedelicalpha.com with more yet to be published. We have some other assorted stories from the last two weeks, so we'll run through them one by one.

Josh Hardman:

So firstly, Fireside Project, a nonprofit that runs a hotline that people can call if they're encountering distressing psychedelic experiences or they just wanna talk about their psychedelic experiences, has published data from over 25,000 interactions with that support line in the journal Science Advances. They say that weather callers reached out during or after an experience predicted distress better than which substance they had taken, and they say that the de identified data will be available to researchers for them to sort of analyze themselves. Elsewhere, Terran Biosciences trade secrets lawsuit against Compass Pathways now has a trial date, so a ten day jury trial has been scheduled to be heard in Baltimore starting September thirteenth next year, by which point Compass's psilocybin should be well to market. Elsewhere, US congressman Steve Cohen has introduced the public health and research reforms in Controlled Substances Act, which essentially aims to have a major shakeup of the Controlled Substances Act, the CSA. It sets out a new sort of and also how countries like The UK and Estonia are preparing for their own sort of models.

Josh Hardman:

Staying in Europe, Norrsken Mind or Norrsken Mind, as I'm told it's pronounced, I've been told many times, but it's quite a difficult one, has issued a request for proposals for a pan European patient registry for psychedelic therapies. So really looking to collect data from all these various systems that we mentioned in that last article that are happening across the block. And now lastly, before we wrap up, I just wanna flag that researchers at Johns Hopkins University are looking for opinions on where the future of psychedelic research should focus. I think this is a really cool initiative. They're basically asking anyone who has an interest whether professionally or personally in psychedelics to give them your views on on what you think are the most pressing areas for psychedelic research to be funded and conducted.

Josh Hardman:

So please do consider filling out that survey. The URL is a bit sorta hectic, but if you type into your browser psychedelicsurvey2026.com, it will redirect you to the survey page. Okay. That's it for our fourth psychedelic News Feed. A reminder that comments on ICER's COMPASS scoping document are due on November 10, and FDA's ibogaine request for information closes November 20.

Josh Hardman:

So a couple of ways to have your voice heard. And as we just mentioned, do consider completing that Johns Hopkins survey on the future of psychedelic research. Again, that's at psychedelicsurvey2026.com. Okay. We'll be back in two weeks.

Josh Hardman:

Thanks for listening. Have a great day. That's it for this edition of the Psychedelic News Feed. For deeper analysis, exclusive interviews, and reporting that you won't find anywhere else, head to psychedelicalpha.com. Have a great day.