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Editor’s Note: The Dutch Medicines Evaluation Board (MEB) is hosting a pipeline meeting on the topic: ‘Regulatory development of psychedelics – therapeutic targets and new indications’. Developers with psychedelic products in their pipeline may apply to meet with MEB and CCMO to present those products and “elaborate on the challenges they face and how they wish or have addressed them”. Three companies will be selected from the applications. Registration closes tomorrow, Friday August 29th. ∎
Lykos Therapeutics Rebrands to Resilient Pharmaceuticals
MDMA drug developer Lykos Therapeutics has changed its name to Resilient Pharmaceuticals, Inc., Psychedelic Alpha understands.
The move comes after British investor and philanthropist Sir Chris Hohn and Musk ally Antonio Gracias teamed up to inject fresh funding into the ailing company, which suffered an FDA rejection last Summer.
That $50M recapitalisation, which the company called a Series B, was quickly followed by the appointment of a new execs, including Mike Burke as CEO and Javier Muniz as CMO.
According to a story published in The Guardian today, Gracias told Doblin at Burning Man last year “that the FDA’s rejection wasn’t his fault”. Instead, he “blamed the company’s other leaders for the failure.”
“Let Lykos go bust and start again with a clean slate, Gracias advised,” the Guardian article continued.
“Resilient is an inspiring name”, Rick Doblin told us today, when he briefly had WiFi at Burning Man.
Pharma Pushes Back on Norway’s Off-Label Ketamine Decision
A decision by Norway’s New Medicines Decision Forum (Beslutningsforum) to reimburse generic ketamine for treatment-resistant depression (TRD), announced on Monday and covered in these pages, was met by many with celebration.
But some in the pharmaceutical industry are not happy at all.
Johnson & Johnson is ‘furious’ according to Norwegian outlet HealthTalk. As we have reported previously, the company’s esketamine nasal spray (Spravato) has been rejected thrice by the Decision Forum, just like the product’s fate at the hands of the UK’s NICE, with both bodies questioning whether the price point of the nasal spray is justified.
Unsurprisingly, then, J&J is upset. Its Norway branch’s Market Access & Government Affairs Lead, Pål Suseg, said that the decision sends an ‘unfortunate signal’, adding that he believes the Norwegian regulator is encouraging the off-label use of ketamine ‘primarily to save money’.
He said that the company has provided additional information, such as longer-term follow-up and real-world data from other countries, multiple times, to no avail. “This unfortunately shows that Norway does not value innovation”, he told HealthTalk.
The Association of the Pharmaceutical Industry in Norway (LMI) also criticised the decision, with the head of patient access Barbara Suter writing in HealthTalk that ‘financially motivated off-label use’ could harm the country’s reputation.
In short, the groups argue that there is an approved drug for this indication—Spravato—but that Norway just doesn’t want to pay for it.
Aside from continuing to give J&J the cold shoulder, instead opting for a much cheaper ketamine-based treatment option for Norwegians, the terms of the approval also cut private clinics out of the mix, at least for now.
At present, ketamine for TRD will only be reimbursed with public funds where it’s delivered in public hospitals or the country’s outpatient mental health services, DPS.
But Lowan Stewart, who we featured in Monday’s coverage, told us that the move “opens the door for insurance companies and company health policies to pay for the treatment”, given that there is now both a ‘thumbs up’ and a price estimate from the health authorities.
Should capacity become overwhelmed, which Stewart expects to be the case, “regional health authorities have an obligation to contract with private clinics to provide the treatment in a timely manner”, he added.
Since the decision was announced, some have wondered whether this might serve as a template for bringing true psychedelics to Norwegians, if they are ultimately approved.
In that case, might the government again undercut a psychedelic product? That seems less likely, as—unlike in the case of ketamine—a psychedelic-based therapy would be first-in-class, meaning there is no generic. Indeed, this situation is perhaps more of an artefact of what happens when you try to commercialise a tweaked form of a widely-available generic drug.
AbbVie–Gilgamesh Deal Viewed as Validation for Short-Acting Psychedelics
Responses to Monday’s news that AbbVie is set to acquire Gilgamesh Pharmaceuticals’ lead candidate, GM-2505 (aka bretisilocin, a serotonergic psychedelic) appear to have been almost universally positive.
Seaport Therapeutics founder and CEO, Daphne Zohar, wrote on Twitter that the deal highlights that “Next gen psychedelics w/ reduced psychoactive experience (trip) [are] heating up”.
Regular readers will recall that Seaport has a 2-Bromo LSD program, as we reported in May. But, as we have also reported, Gilgamesh’s lead is very psychoactive, even at the 1 mg active control dose! (Zohar later updated her Tweet, which now reads: “w/ reduced time psychoactive experience”.)
It does look like big pharma’s Overton window, with regard to psychedelics, has gone from a narrow interest in potential non-hallucinogenic psychedelics, or psychoplastogens, to now include short-acting psychedelics.
As we have written many times over the past years, investors had cottoned on to this preference for shorter-acting psychedelics quite some time ago. Adrienne Jo, a Senior Associate at VC fund Palo Santo, wrote on LinkedIn that the deal “validates…our conviction that rapid, durable treatments delivered through short in-clinic visits are advancing toward patient impact at scale.” Gilgamesh is Palo Santo’s largest holding in its first fund.
Teja Mullapudi, a Principal at Noetic Fund, told Psychedelic Alpha that he is “elated that a major pharmaceutical company like AbbVie is going to help and support the development of a paradigm-shifting treatment option for many suffering from Major Depressive Disorder.”
Speaking on behalf of the fund, he added: “We also commend the Gilgamesh team for having the highest standards for drug development in a chaotic set of years spanning COVID-induced disruptions and investor trends.”
Specifics around the deal, such as how much of the $1.2bn is to be paid upfront, remain elusive.
(Disclosure: Psychedelic Alpha Editor Josh Hardman worked at Noetic Fund when the investment in Gilgamesh’s seed round took place.)
Psilocybin Rescheduling Petition Heads to HHS
In January 2021, lawyers approached the DEA on behalf of Dr. Sunil Aggarwal, a Seattle-based physician and co-founder of Advanced Integrated Medical Science (AIMS) Institute. The doctor was hoping to rely on state and federal Right to Try laws to provide psilocybin to his patients with life-threatening conditions.
The group then filed a rescheduling petition in early 2022, seeking to have psilocybin moved from Schedule I to Schedule II. In doing so, they wanted DEA to acknowledge that the drug has a currently accepted medical use with severe restrictions.
DEA denied the petition in a two-paragraph letter, pointing to the fact that the drug is not FDA-approved. However, the Court of Appeals for the Ninth Circuit instructed the agency to reconsider its denial, urging it to address the arguments presented in the petition rather than issuing a blanket rejection.
In February 2025, the DEA contacted the Petitioner to notify them that it was preparing to transmit the petition to the Department of Health and Human Services (HHS), and provided them the opportunity to supply any additional information. They did just that, including research that had been published since the original filing.
On August 11th, DEA formally sent the petition to HHS for scientific and medical review.
Once HHS produces its scientific review and rescheduling recommendation, it’s back to the DEA to decide whether to start formal rulemaking proceedings. The DEA could, of course, sit on it.
Speaking on The Dales Report podcast, lawyer Shane Pennington described the transmission of the petition to HHS as “a big deal”, noting that usually, the DEA is the primary roadblock when it comes to scheduling actions. (Pennington, along with the likes of Kathryn Tucker and HHS Deputy General Counsel Matt Zorn, has represented the Petitioners.)
In the case of cannabis, it took President Biden’s directive to have HHS look at the matter. In that case, HHS produced its analysis and concluded that it should be placed in Schedule III, which it detailed in a letter sent to former Attorney General Merrick Garland and former DEA administrator Anne Milgram in February 2024.
“We feel good about where we are, and getting it to HHS is a huge deal”, Pennington said about the psilocybin rescheduling petition. Still, “as we all know from the cannabis history, we have a little ways to go yet”, he added. Indeed, cannabis remains in Schedule I, despite HHS’ rescheduling recommendation 18 months ago.
Aggarwal, the Petitioner, told Psychedelic Alpha that he is “very happy” about the development. “This is a serious health and human rights matter”, he went on, which is “especially pressing for those who have life-threatening and terminal illnesses who have a legally protected yet presently obstructed right to try psilocybin”.
“I sincerely hope HHS acts expeditiously on rescheduling psilocybin and lets the medical and scientific record for this twice-FDA-granted Breakthrough Therapy status drug speak for itself”, Aggarwal added.
Robert Rush, attorney and founder of the Rights and Reason Project, also described the move as “positive”.
“Much of the litigation has revolved around the DEA’s definition of Currently Accepted Medical Use”, Rush told Psychedelic Alpha. Whether a drug meets that standard is determined by a five-factor analysis that DEA developed, which has come under scrutiny from those inside and outside of government.
“While Congress defined the agency as a law enforcement agency, the DEA has become a gatekeeper of access to medicine”, Rush went on, pointing to what he believes are more fundamental issues with how the agency perceives its remit. “The DEA was never intended to be an agency regulating medicine and scientific research.”
Advocates are hoping that Trump’s loud introduction of the Right to Try Act in his first term, coupled with his present coterie’s apparent enthusiasm for psychedelics like psilocybin, could bolster their chances of success.
But FDA data shows that the Right to Try Act is not leading to a great deal of access, with just five drugs and biological products accessed in 2024 through the scheme.
Sensorium Scores $25M Series A Extension to Take Kanna-Based Candidate Into Clinic
Last week, Endpoints reported that Sensorium Therapeutics has raised a $25M Series A extension, with support from Mission BioCapital, Hatteras Venture Partners, Mockingbird Capital Partners, and Dolby Family Ventures. Existing investors in the company also participated in the round.
The company had expected to enter the clinic last year, using its $30M Series A funding, but evidently faced delays. The fresh funding is now expected to take its lead, SNTX-2643, through that Phase 1 study, in which the first participant has now been dosed.
The Phase 1 program includes single- and multiple-ascending dose studies, food-effect, and PET target occupancy studies, CEO Jacob Hooker told us, though he would not provide an estimated timeline for readouts.
That might be wise, given earlier delays. “We took a very rigorous approach in selecting our development candidate for anxiety”, Hooker said in response to a question about the hold-up. “Along the way, we optimized the molecule to improve oral bioavailability, extend half-life, and reduce metabolic liabilities”, all of which led the company to SNTX-2643, he added.
SNTX-2643 is related to Sceletium tortuosum, better known as kanna, and the company aims to develop it for social anxiety disorder (SAD). Hooker described it as “a psychoactive but not a psychedelic molecule.”
Researchers Call Lykos’ MDMA Pricing Modelling “Problematic”
A new article by Elliot Marseille and Jennifer Mitchell (2025) critiques a cost-effectiveness analysis (CEA) of MDMA-assisted therapy (MDMA-AT) for PTSD that was funded by Lykos Therapeutics and published in November 2024 (Stanicic et al., 2024).
They argue that the pricing of MDMA used in the modelling—$12,000 per dose—is “problematic” and “threatens accessibility”.
We spoke to Marseille about the paper, as well as his thoughts on which conditions might prove to be the most cost-effective ones to treat with psychedelic therapies.
***
Psychedelic Alpha: You take issue with the pricing scenario discussed in the Lykos analysis. What price ceiling do you suggest to make MDMA-AT for PTSD attractive to payers and to ensure more equitable access?
Marseille: In our 2022 modeling, we used $11,500 for the full 3-dose course (≈ $3,500 per session).
That yields an [incremental cost-effectiveness ratio] ICER of roughly $47,500/[quality-adjusted life-year] QALY, assuming (conservatively) only one year of benefit. MDMA-AT breaks even at roughly 4 years of benefit, and anything beyond 4 years means MDMA-AT is not just cost-effective (good use of money) but actually saves health care dollars. But this assumes very low cost of the MDMA itself: $490 for all three sessions.
By contrast, the $36,000 drug price assumed by Lykos’s CEA, the payer break-even point is about 8.5 years, far beyond typical commercial enrollee tenure. This delays cost recovery for payers, weakening incentives to cover the therapy. The lower the drug price, the sooner payers reach break-even, and the more attractive MDMA-AT becomes. Pricing also affects equity and access: a lower drug cost frees “headroom” to compensate clinicians adequately, which is crucial to easing workforce bottlenecks.
In short, while MDMA-AT remains cost-effective even at Lykos’s high price under a $150,000/QALY threshold, a substantially lower ceiling is needed to make the therapy both payer-friendly and accessible.
Psychedelic Alpha: Is it likely that Lykos would have arrived at that sort of price anyway through payer discussions?
Marseille: Unlikely without strong external pressure. Their own CEA anchors drug cost at $12,000 per session ($36,000 per course) and still calls the result “cost-effective” at an $83,845/QALY. They even explore thresholds that allow MDMA drug costs of >$14,000 per session under a $100k/QALY willingness-to-pay threshold. This may signal a materially higher pricing ambition than what payers would find compelling in real-world comparisons.
Moreover, their analysis offers no transparent logic tying the proposed price to verifiable R&D recovery needs. In practice, they would likely start with high list prices and negotiate rebates, rather than voluntarily targeting a payer-friendly range, unless pressured by payers, regulators, or HTA bodies.
Psychedelic Alpha: Outside this analysis, which conditions (or groups of conditions) are most likely to show strong cost-effectiveness for psychedelic therapies?
Marseille:
- PTSD (MDMA-AT): The clearest case. Multiple CEAs (using standard-of-care comparators) show cost-saving or very attractive ICERs with reasonable pricing and observed durability.
- Major depressive disorder (psilocybin): Early modeling suggests cost-effectiveness is plausible, especially for treatment-resistant depression but results are sensitive to support costs and net price. Efficacy evidence continues to strengthen, but HTA-grade CEAs remain limited.
- Substance use disorders (notably AUD and tobacco): Early RCTs report large treatment effects (e.g., psilocybin reducing heavy-drinking days; high abstinence rates in smoking cessation pilots). Given the high downstream medical and societal costs of addiction, even moderate durability would likely translate into favorable CEAs once priced and delivered efficiently (e.g., group formats). Formal CEAs are still sparse, but the signal is strong.
- Ibogaine holds early promise of cross cutting efficacy including opioid use disorder and traumatic brain injury. Again, given the high medical and societal costs of these disorders, ibogaine-assisted therapy too, may deliver favorable cost-effectiveness.
Finally, group delivery models—already under exploration—could halve clinician time for MDMA-PTSD and substantially reduce costs for psilocybin-MDD, directly improving cost-effectiveness and scalability.
***
Editor’s note: Since the Lykos-funded cost-effectiveness analysis was published, the company has undergone major changes, including the arrival of new investors who apparently have a less revenue-focused orientation. It even has a new name, Resilient, as discussed above.
Other Stories
Alabama Board of Medicine Issues Guidelines for Off-Label Ketamine in TRD
The Alabama State Board of Medical Examiners has issued a four-page position statement on and guidelines for the off-label use of ketamine for treatment-resistant depression (TRD) in outpatient settings (PDF).
Among other things, it stipulates that:
- prescribing and administering ketamine in outpatient settings for TRD should be done by Alabama licensed physicians only;
- the prescribing physician must remain on-site;
- the facility must have certain emergency medical equipment, like a crash cart;
- psychotherapy should be considered in tandem with ketamine administration;
- ketamine infusions should not be administered more than twice a week;
- and, physicians “should never allow the patient to administer ketamine for psychiatric reasons at home”.
FDA Approves PharmaTher’s Ketamine After Two CRLs
Earlier this month, PharmaTher announced FDA approval of its ketamine product, KETARx, for surgical pain management.
Prior to the approval, KETARx received two Complete Response Letters from the agency since it filed its Abbreviated New Drug Application (ANDA) in September 2023. It had initially planned to launch in Q2’24.
Upon accepting the ANDA, FDA set a Generic Drug User Fee Amendments (GDUFA) goal date of April 29th 2024. Throughout its press releases, the company emphasised ketamine’s use in mental health, neurological, and pain disorders—not emphasising (or even mentioning, in many cases) surgical pain.
“The Company’s overall goal is to solve the ketamine shortage problem in the U.S.”, it has said many times. Indeed, a slide in a KETARx investor presentation anticipates FDA removing ketamine from its Drug Shortages list and thus reigning in compounding pharmacies’ distribution of the drug
In that scenario, it hopes to ‘fill the void’.
In February 2024, the company shared that the agency had some concerns around possible deficiencies in the Quality realm, before it announced, in April, that it had received a CRL focused on those areas. It responded, and a new GDUFA goal date of October 29th was set
PharmaTher received a second CRL in October, with ‘minor’ deficiencies identified, it said. “The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology.”
Having responded to those issues, the company announced a new FDA approval goal date of June 4, 2025, which then became August 9. On August 11th, the company announced approval. Shares in the company dropped sharply on that news.
It’s not the only company looking to market racemic ketamine, however. NRx Pharmaceuticals is looking to bring its preservative-free IV ketamine formulation (NRX-100) through to approval for suicidal ideation in patients with depression (including bipolar depression). Earlier this month, FDA granted the program a Fast Track designation.
More to come.
Incannex Reports Positive Phase 2 Results for Psilocybin-Assisted Psychotherapy in GAD
Earlier this week, Incannex Healthcare shared positive topline data from its Phase 2 trial of psilocybin-assisted psychotherapy for generalised anxiety disorder (GAD).
The study enrolled 73 adults with moderate to severe GAD, who were randomly assigned to receive two dosing sessions with 25 mg psilocybin or placebo, alongside a “proprietary psychotherapeutic protocol”.
Those in the psilocybin arm saw an average 12.8-point reduction on the Hamilton Anxiety Rating Scale (HAM-A) versus a 3.6-point reduction in the placebo arm. The statistically significant difference persisted through the 11-week follow-up period, the company said.
On the safety front, the company reports that there were no serious adverse events, with just one withdrawal during the 7-week program.
Incannex says that it now plans to initiate a multi-country Phase 2 study, and that it has an open IND application with FDA. It also says that it’s “exploring strategic partnerships to accelerate development”. That’s not surprising, given the company is not exactly flush with cash
Other Headlines
MDMA Use Jumps in Australia. According to the Australian Criminal Intelligence Commission (ACIC), its national wastewater drug monitoring program has identified a significant increase in the amount of MDMA consumed in August 2024 versus August 2023, up 49%. While the data is a lagging indicator, ACIC says that its modelling suggests the rise is likely to continue through 2027, but at a lower clip.
Reconnect Labs Emerges from Stealth. University of Zurich spin-out Reconnect Labs has officially emerged from stealth, according to an article in Swiss outlet Startup Ticker CH. The company is developing a few candidates, including RE01, a combination of DMT and harmine.
Alaska Psychedelics Ballot Initiative Starts Collecting Signatures. A ballot initiative that would give Alaskans the chance to decriminalise certain psychedelics and establish a regulated system for their use has been certified, meaning advocates can now begin collecting signatures. It’s similar to Colorado’s Natural Medicine Act, which is now being rolled out.
Osmind Publishes Real-World Evidence on Ketamine for PTSD and Comorbid Depression. Analysis of real-world data reflecting just over 8,000 PTSD patients—87% of whom had comorbid depression—demonstrates that IV ketamine therapy significantly reduced PTSD and depression symptoms, according to McInnes et al. (2025). The study, funded by Osmind, found that the greatest benefits were observed during the first 3 doses.
Angermayer Pumps Further Cash Into atai as Marketcap Surpasses $1bn. Last week, atai Life Sciences co-founder and chairman Christian Angermayer purchased an additional 8.6 million shares of the company. It is currently the only publicly-traded psychedelics company with a marketcap of $1bn+.
Preclinical Study on Cardiovascular Risks of Microdosing. A study that chronically administered mice with serotonin, d-fenfluramine or LSD at two subhallucinogenic doses for 8 weeks found no significant cardiovascular changes in the LSD or vehicle groups. It is a welcome finding, given concerns around chronic 5-HT2B agonism’s potential impact on the heart, though human studies are still needed.
EYWA Licenses Psilocybin Biosynthesis Tech from Miami University. EYWA Biotech is licensing psilocybin biosynthesis technology from Miami University, which the company’s co-founder and CSO Paola Rodriguez thinks “overcomes key bottlenecks in psilocybin biosynthesis”.
Colorado Natural Medicine Advisory Board Emphasises Nagoya Protocol Compliance. In its August Board meeting, Colorado’s Natural Medicine Advisory Board made the following recommendation: “The state write a letter of intent to start and follow Nagoya Protocol, the state should request a waiver to the Controlled Substance Act from the Federal Government to import Iboga or Ibogaine extract/powder from existing Gabon infrastructure that is Nagoya protocol compliant.” In a notice published on the Department of Regulatory Agencies’ website, the Board states that its intent and recommendation is that “any ibogaine sourcing into Colorado follow the Nagoya protocol and is culturally sensitive.” It will provide its recommendation to the Executive Directors of both the Department of Regulatory Agencies and the Department of Revenue, which oversee the program.
‘Singularism’ Tests Utah’s Religious Freedom Restoration Act. The leader of Singularism, a religious group based in Utah, is suing after police seized psilocybin from its headquarters in 2023 and slapped him with criminal charges. Earlier this month, a federal judge sided with the group, which points to the state’s version of the Religious Freedom Restoration Act, which was codified last year. The federal judge denied Utah County’s request to have the lawsuit dismissed and directed it to halt all criminal proceedings against the group and its founder until the lawsuit is settled.
Rick Perry and Kyrsten Sinema Both Tried Ibogaine. A New York Times article published earlier this month revealed that both former lawmakers have experienced ibogaine. It’s unclear whether this fact will help or hurt their advocacy.
Study Suggests No Significant Association Between Amount of Therapy Hours and Outcomes with Psilocybin. A study published earlier this month in General Hospital Psychiatry details a meta-analysis of the relationship between number of therapy hours and treatment outcomes in psilocybin-assisted therapy. The authors report that there was no statistically significant association, but note that the strength of their analysis “was limited due to inadequate reporting and lack of standardised therapy protocols.” Speaking to Psychedelic Alpha, researcher Robin Carhart-Harris said that “it may reflect inaccurate reporting of therapy hours across sites/PIs or that therapy (in this context) is most important for maintaining safety than maximizing efficacy.” “It’s interesting”, he continued, “but really needs a controlled study to properly test.” He plugged such a study that his group is working on.
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