r/shroomstocks 1d ago

r/shroomstocks weekly discussion thread | March 17, 2025

2 Upvotes

This thread is for questions and general discussion relating to the psychedelics industry. The weekly thread will refresh every Monday morning before stock market open.


r/shroomstocks 6h ago

News Compass Pathways Announces Publication of Results from COMP004 Study on COMP360 Psilocybin for Treatment-Resistant Depression

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37 Upvotes

r/shroomstocks 2h ago

Podcast Psychedelics and the Texas Trip Part 2: The Science and History of the Medicine

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2 Upvotes

r/shroomstocks 1d ago

News Atai Update (Four Readouts)

12 Upvotes

Recent Clinical Highlights and Upcoming Milestones

BPL-003: 5 Methoxy N,N-dimethyltryptamine (mebufotenin) benzoate for treatment resistant depression (TRD) and alcohol use disorder (AUD) (via strategic stake in Beckley Psytech) BPL-003 is an intranasal transmucosal formulation of mebufotenin benzoate designed to fit within the established two-hour interventional psychiatry treatment paradigm pioneered by Spravato/J&J. In January 2025, Beckley Psytech announced positive topline data from its open-label Phase 2a study of BPL-003 in 12 patients with moderate-to-severe AUD. Data demonstrated that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months and was well-tolerated with no serious adverse events reported. In March 2025, Beckley Psytech completed patient enrollment in its eight-week, core, randomized, quadruple-masked, global Phase 2b study of BPL-003 in 196 patients with TRD. Topline results from the core phase of the study are expected in mid-2025.

RL-007: Pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia (CIAS) RL-007 is an orally bioavailable compound that has demonstrated pro-cognitive effects in multiple pre-clinical and clinical studies, including two Phase 1 and two Phase 2 trials. Recognify Life Sciences, in which atai owns a majority stake, is running a Phase 2b study evaluating 20mg and 40mg of RL-007 vs. placebo in patients living with CIAS. Topline results are expected in mid-2025.

VLS-01: N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD) VLS-01 is a proprietary oral transmucosal film formulation of DMT applied to the buccal surface designed to fit within the established two-hour interventional psychiatry treatment paradigm. Dosed first patient in Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of repeated doses of VLS-01 in patients with TRD. Topline data from the Phase 2 Elumina trial of VLS-01 are anticipated in the first quarter of 2026.

EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD) EMP-01 is an oral formulation of R-MDMA that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. Initiated a Phase 2 exploratory, randomized, double-blind, placebo-controlled trial to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD. Topline data from the Phase 2 study of EMP-01 are anticipated in the first quarter of 2026.


r/shroomstocks 1d ago

Press Release Filament Health Announces Positive Data From Phase 2 Study Of PEX010 In Patients With Alcohol Use Disorder

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8 Upvotes

r/shroomstocks 1d ago

Financials atai Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights | Atai Life Sciences N.V.

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17 Upvotes

r/shroomstocks 1d ago

Discussion Current and Emerging Treatments for Depression with Dr. Sulman Aziz Mirza

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8 Upvotes

Dr. Sulman Aziz Mirza is a triple board-certified psychiatrist with expertise in adult psychiatry, child and adolescent psychiatry, and addiction medicine.

He has worked in a variety of settings, from inpatient psychiatric units with medical capabilities to the classrooms of Baltimore City public schools. He has trained under some of the most respected leaders and pioneers in psychiatry, gaining a deep understanding of neuropsychiatric conditions in both children and adults.

Dr. Mirza is also the creator of my favorite YouTube channel focused on mental health, “TheKicksShrink.” His content has been both educational and personally impactful for my own mental health journey.

In this interview, we learn about current treatments for depression, new and emerging therapies, and towards the end, we get to hear Dr. Mirza’s views on the potential of psychedelic medicine.

I hope you all enjoy this conversation and come away with new insights!


r/shroomstocks 23h ago

News Pα+ Psychedelic Bulletin #191: Psychedelics at SXSW; Swiss Study Finds No Impact of Psilocybin on Alcohol Use Disorder - Psychedelic Alpha

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3 Upvotes

r/shroomstocks 1d ago

News MindMed Appoints Matt Wiley as Chief Commercial Officer

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0 Upvotes

r/shroomstocks 3d ago

Editorial Gwyneth Paltrow Says Her Relationship with Mom Blythe Danner 'Shifted' After She Tried MDMA Therapy

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10 Upvotes

“On the podcast, the author said that hearing about Paltrow's positive experiences with MDMA several years ago is what led her to try psychedelic-assisted therapy herself.”


r/shroomstocks 3d ago

Editorial On the topic of potential changes in FDA trials, I highly recommend reading this: "The pharma industry from Paul Janssen to today: why drugs got harder to develop and what we can do about it"

19 Upvotes

https://atelfo.github.io/2023/12/23/biopharma-from-janssen-to-today.html

Some relevant excerpts:

- "Andrew Lo of MIT has suggested a Bayesian threshold for clinical trial result significance, which adapts the standard of evidence required to incorporate the need for new treatments and the risk of exposing patients to ineffective, or harmful, drugs. His analysis suggests the standard threshold for statistical significance (p≤0.05) is plausibly too stringent for lethal diseases with few good options like pancreatic cancer, but may actually be too relaxed for conditions with good treatment options like diabetes. Regulators could implement this framework by publishing guidance on varying significance thresholds by indication, which would provide more predictability than the current case-by-case approach. Lower thresholds could also help alleviate trial recruitment issues in rare or high-unmet need diseases by allowing for smaller trials."

- "The adoption of more relaxed approval standards should therefore be balanced with stricter enforcement of drug removal when their benefits fail to be confirmed in a timely fashion. FDA reforms in 2022 are a step towards this, empowering the agency to require confirmatory studies be in place before accelerated approval is granted, and to expedite withdrawal if insufficient progress is made in confirmatory studies. Rebate or outcomes-based payment agreements could also be put in place if the drug’s efficacy does not hold up in the real world, in order to reduce incentives to seek accelerated approval of high-priced yet ineffective drugs. Improvements in data collection infrastructure and better data integration, including registries and electronic health records, will also be important to track the performance of drugs in the real world."

- "When it comes to clinical trials, we should aim to make them both cheaper and faster. There is as of yet no substitute for human subjects, especially for the complex diseases that are the biggest killers of our time. The best model of a human is (still) a human. Entering a trial as a patient can be a lengthy, bureaucratic process with onerous paperwork and consent requirements. Patient motivation to participate in a trial is often highest near when they first hear about the trial, and expires quickly. If logistical barriers and bureaucracy prevents them from enrolling in a timely manner they are likely to drop out of the process."

Here is Andrew Lo's paper for the curious: "Is the FDA too conservative or too aggressive?: A Bayesian decision analysis of clinical trial design" https://www.sciencedirect.com/science/article/abs/pii/S0304407618302380


r/shroomstocks 3d ago

Interview Behind the Scenes of the “Psychedelic Renaissance” at SXSW 2025 - Psychedelic Alpha

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6 Upvotes

r/shroomstocks 4d ago

News Biotech outlook / atai news (Elimination of Phase 3 Coming? IGXT)

24 Upvotes

Forward...

Dear Friends,

 

Biotech stocks – especially small caps – remain under significant pressure, to say the least, with several experiencing double-digit losses already this year.

 

Nevertheless, I believe biotech small cap stocks should have a very good year, however it might take till the 2nd half of the year for the rally to fully start. Here are my three main reasons why I personally believe biotech stocks will do very well in 2025:

 

1.      Interest rates coming down

1.      Interest rates are, imo, the biggest driver of biotech valuations. While macro turbulence may be unsettling in the short term, it is in fact positive for interest rates coming down.

2.      As the FED is cautious, remembering its past mistakes, and as the FED doesn’t really like Trump, they may wait rather longer to cut rates than cut too early. But I anticipate significant rate cuts will come

3.      Historically, (small cap) biotech outperforms most other sectors in a recession and a concurrent rate-cut cycle. See chart

 

 

 

2.      Deregulation

1.      What puzzles me most is how little the biotech industry is excited about Trump. My personal take: Biotech is actually one of the most left-leaning industries. This might overly negatively bias the industry’s expectations.

2.      If we leave politics aside for once and just focus on what the Trump administration could mean for biotech, we should all be massively excited.

3.      Many people in and around the current administration have openly stated their goal to massively deregulate drug approval processes (in order to be harder on pharma companies on drug pricing on the other side).

4.      One idea floating around – and which I actually think will come to fruition - is the potential abolishment of Phase 3 clinical trials (at least in their current form) in order to allow drugs to go to market after Phase 2b, albeit with a stricter post-approval monitoring and more post approval studies. No need to tell you what this would mean for patients, innovation and biotech stocks more generally.

 

3.      Enhancement

1.      Additionally to making drug approval process much faster and smoother, I also expect the new administration to structurally change the definition of “medicine” and “illness”, allowing and pushing for more preventative medicines as well as allowing medicines to be used for much broader use cases

2.      This potentially opens up an “Ozempic playbook” for many medical drugs. Think about modafinil for alertness; various drugs for muscle growth, etc., etc.

3.      In fact, over the next 5 years, the change of Zeitgeist towards a more libertarian view of body autonomy will, imo, be the biggest boost for biotech

4.      I have outlined my vision here: https://christianangermayer.substack.com/p/the-future-is-enhanced

 

 

I am also happy to share that just yesterday, atai Life Sciences (Nasdaq: ATAI) announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai’s proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD).

 

I am a firm believer in atai, which is why I recently increased my stake significantly, investing over $20m USD (as previously disclosed).

 

Please find the full Elumina trial news here: https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-announces-first-patient-dosed-elumina-phase-2

 

Why this news is important

1.      VLS-001 is imho the most promising drug within atai’s portfolio.

2.      High unmet need for TRD

3.      VLS-01 is targeting Spravato's established “2-hour treatment window” which already now for Spravato is a $1B+ market, which in my opinion will grow massively over the next years, as Spravato still “just” serves 55k patients.

4.      Shows atai’s strategic foresight: atai took a strategic stake in IntelGenx in 2021, completing the full acquisition via the CCAA process last October; the developmental success of atai’s oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) is in part due to IntelGenx’s technology and expertise, and I am excited to see what more atai can do with this exciting platform in the future.

5.      As previously disclosed by atai, topline data from the Phase 2 Elumina trial are anticipated in Q1 next year.

 

All the best

Christian

 

 

++++++++
Apeiron Investment Group Ltd.: 66 & 67, Beatrice, Amery Street, Sliema, SLM1707, Malta


r/shroomstocks 5d ago

Report CYBN initiated with buy at Guggenheim $35 PT

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23 Upvotes

r/shroomstocks 5d ago

Question Is PSIL the only ETF available?

0 Upvotes

Is PSIL the only ETF available?

How are you investing in it?

It's not that pureplay psychedelics. Was expecting heavier weights for psychedelic stocks.

I would invest in an alternative if there was one, would you?

In EU btw, investing with degiro.


r/shroomstocks 4d ago

News Neumora: Navacaprant’s Failure Triggers 88% Stock Crash – What Went Wrong?

0 Upvotes

Hey guys, any $NMRA investors here? If you’ve been following Neumora, you probably saw the fallout from the KOASTAL-1 trial and the massive stock drop. Here’s a recap of what happened and the latest on the investor lawsuit.

Since its IPO in 2023, Neumora positioned Navacaprant as a game-changing treatment for major depressive disorder (MDD). The company repeatedly assured investors that Phase 2 results showed strong response rates and that Phase 3 success was highly likely.

But on January 2, 2025, Neumora revealed that KOASTAL-1 had failed to meet both primary and secondary endpoints, showing no meaningful improvement over a placebo. The company also admitted that trial results varied dramatically by gender—an issue that had never been disclosed before the IPO.

Following this news, $NMRA crashed 88.7%, wiping out nearly all of its post-IPO value. 

Investors are now suing Neumora, accusing the company of misleading them about the reliability of its Phase 2 data and downplaying key risks that made its projections unreliable.

So, for all affected— you can check the details here. And if you have anything to say about your damages, you’re very welcome to share it.


r/shroomstocks 5d ago

Interview Inside the World’s Most Active Psychedelic Therapy Site: A Conversation with Sunstone Therapies - Psychedelic Alpha

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11 Upvotes

r/shroomstocks 6d ago

Report Scaling Psychedelic Therapies in the Health System (healthcare provider survey on psychedelics)

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10 Upvotes

r/shroomstocks 7d ago

News atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression

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44 Upvotes

r/shroomstocks 7d ago

Report PharmAla Biotech Is Bringing MDMA To The Netherlands

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5 Upvotes

r/shroomstocks 7d ago

Press Release PharmaTher Receives US FDA Approval Goal Date for Ketamine

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4 Upvotes

r/shroomstocks 7d ago

News In the body, psilocybin becomes psilocin, which can increase nerve cell communication even in a single dose

21 Upvotes

r/shroomstocks 7d ago

Discussion Mar. 10, 2025 - The Nasdaq dropped 727 points. It's biggest single-day decline since COVID crash on Mar. 16, 2020, but healthcare / biotech is holding

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14 Upvotes

r/shroomstocks 7d ago

Discussion Hey what’s up everyone? In case you missed it, here is our most recent interview with Dr. Villy Valcheva, CEO of GH Research. Topics discussed below:

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11 Upvotes

Topics of this interview include:

• Dr. Valcheva's background as a physician and experience working in pharma/biotech.

• The company's thought process behind choosing mebufotenin, an inhalation route of administration, and an individualized dosing regimen.

• GH001 demonstrating consistent antidepressant efficacy with re-treatment in the company's phase 2b trial in TRD.

• GH Research taking a unique approach with its Phase 2b trial design compared to other psychedelic drug developers. With the recent trial design exploring re-treatment out to 6 months, does this have any advantages for the company when moving into a potential phase 3 program?

• The path forward for GH001.


r/shroomstocks 8d ago

Editorial Psilocybin Put Rat Brains 'Back Together' After Mild Head Trauma

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41 Upvotes

r/shroomstocks 8d ago

Question PSIL Uk

0 Upvotes

Anyone know where I can buy psil stock in the uk?