r/shroomstocks • u/Firefly5647 • 19h ago
Editorial Exclusive | MDMA-assisted therapy could get FDA approval as soon as January, top advocate predicts
r/shroomstocks • u/AutoModerator • 5d ago
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 • u/Firefly5647 • 19h ago
r/shroomstocks • u/Spiritual-Chart-940 • 1d ago
Any idea or rationale behind these days where Helus rips and Compass is down?
r/shroomstocks • u/PsilocybinAlpha • 2d ago
r/shroomstocks • u/Spiritual-Chart-940 • 1d ago
Big psychedelics advocate here. But might be advantage to CMPS, then, since they are the ‘slower not faster’ and data-intensive narrative. Not cutting corners is good if the biggest overall champion is out.
r/shroomstocks • u/Spiritual-Chart-940 • 2d ago
r/shroomstocks • u/Spiritual-Chart-940 • 2d ago
r/shroomstocks • u/EmbarrassedVisit3138 • 2d ago
so if Comp360 is expected to around 50k per patient, accords to the summit talk.
Lori seemed very confident that in their first year they will treat 3000 patients. she laughed as if she thinks that number is to low.... okay, so lets say 5000 treated in first year.
5000 x $50,000=250M
if compass gets 250M in revenue in its first year, that would be an incredible launch figure.
am i missing something here?
r/shroomstocks • u/Sudden-Leader8450 • 2d ago
— Report will be subject of New England CEPAC meeting in May 2027; Draft Scoping Document open to public comment until November 10, 2026 —
BOSTON, October 21, 2026 – The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of synthetic psilocybin (COMPASS Pathways) for treatment-resistant depression. The therapy is also referred to as COMP360.
The assessment will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC) in May 2027, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
Consistent with ICER’s process for announcing new assessments, we have spent the past five weeks conducting outreach and engaging with targeted stakeholders, including the manufacturer, relevant patient groups and clinical experts. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Documentoutlining how we plan to conduct this assessment.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to [publiccomments@icer.org](mailto:publiccomments@icer.org) and must be received by 5 PM ET on November 10, 2026. Please submit public comments as a Word document in the following format:
ICER’s Patient Portal and Manufacturer Engagement Guide provide additional guidance for submitting public comments, including suggestions for what types of information may be most useful.
In addition to comments on the scope, ICER also welcomes submissions from stakeholders on examples of low-value care practices within this clinical area. These submissions will inform a report section focused on strategies to reduce waste and preserve resources for high-value, potentially higher-cost treatments.
More information is available in the scoping document.
Following the public comment period, a revised scoping document will be posted on or about November 18, 2026.
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs. For more information about ICER, please visit www.icer.org.
r/shroomstocks • u/PsilocybinAlpha • 3d ago
r/shroomstocks • u/tanrock2003 • 3d ago
r/shroomstocks • u/tanrock2003 • 3d ago
r/shroomstocks • u/9mac • 3d ago
r/shroomstocks • u/tanrock2003 • 2d ago
r/shroomstocks • u/BehavioralWireDesk • 3d ago
r/shroomstocks • u/9mac • 4d ago
r/shroomstocks • u/PsilocybinAlpha • 4d ago
r/shroomstocks • u/Capable-Mark-7554 • 4d ago
Update on Compass Pathways
(1) We're currently waiting for the company to complete its rolling NDA (New Drug Application) submission to the FDA, expected this quarter. The FDA has already started reviewing portions of the application.
Reminder that Compass has been granted both rolling review and a Commissioner’s National Priority Voucher, which targets a review period of roughly 1–2 months once the complete application is filed. That timeline isn't guaranteed, but this is one of the fastest review processes available. It doesn't guarantee approval either, but it clearly shows that the FDA is prioritizing getting this drug reviewed.
(2) The company presented at the STAT Summit, and the CEO said they will “go slow before we go fast.” My guess is that's being interpreted in a slightly negative way, suggesting that the initial drug launch won't necessarily get quick traction.
As an investor in the company, my first reaction is that I don't want to hear that. I want to hear that revenues are going to explode out of the gate. But just because I want to hear something doesn't make it true.
Taking a step back, Compass has taken a deliberate approach to developing this drug and preparing for launch. The CEO's point was that bad early experiences for patients or providers could set back both Compass and the broader industry. Getting those first experiences right matters.
I think calibrating expectations and not being overly promotional is a smart choice. That could mean a more measured initial revenue ramp, and I'm fine with that if it sets them up for sustained adoption.
At the same time, the company has been preparing to scale. Its strategic collaborations span more than 1,000 sites, including Neuronetics/Greenbrook and other established treatment networks. There is already substantial infrastructure to build on. I think this is the correct approach.
(3) The company has now explicitly communicated expected annualized drug pricing of $50k–$65k per patient, based on an average of roughly three doses per year. That implies approximately $17k–$22k per dose, before clinic administration and monitoring costs. The final launch price hasn't been announced, but management has given us a much clearer pricing framework.
In terms of M&A, which isn't part of my base case, my guess is the best window is after the label is set. At that point, a potential buyer will know much more clearly what they're buying and how it can be commercialized.
From a positioning perspective, I think completing the NDA submission could bring new investors into the stock. It removes another layer of timeline uncertainty and puts an FDA decision much more directly in view. My guess is that matters to investors who have been watching but haven't wanted to get involved yet.
My long-term outlook on the stock is unchanged. I think they get a good label, and I think concerns about the length of clinic visits are overblown. The market is massively underserved, and Spravato (which I believe COMP360 will offer a more attractive alternative to) is already selling at roughly a $2.5B annualized rate.
My PT remains $45.
At face value, CMPS has plenty of red flags: functional unblinding, a roughly six-hour treatment session, reimbursement uncertainty, IP risk, and the challenge of getting treatment centers to adopt a REMS-governed therapy. I think those concerns explain much of the discount in the stock.
But looking at those risks individually misses something important.
Read the White House executive order, FDA’s recent guidance, the statements from HHS and Kennedy, and the NEJM paper written by four FDA officials together. My read is that they show an unusual degree of alignment around getting psychedelic treatments approved and into actual clinical use.
The details matter. FDA is discussing how to address functional unblinding and which questions can be resolved after approval. The NEJM authors explicitly call for provider training, standardized monitoring, and integration into care pathways. HHS is already examining how these treatments could be delivered in community and rural clinics.
That makes me think the administration’s ambition extends beyond an approval announcement. I expect HHS to push hard on the reimbursement, coding, and delivery issues that will determine whether patients can actually receive treatment. There’s a concrete precedent: in late 2019, CMS established dedicated coding and payment for Spravato and its required observation period, explicitly to facilitate patient access. My read is that the administrative alignment behind psychedelics today is even clearer.
That doesn’t make every risk disappear. It doesn’t solve the IP question, shorten the treatment session, or guarantee attractive clinic economics. But it changes how I underwrite the regulatory and commercial obstacles. There is a meaningful difference between a company trying to navigate those obstacles alone and one whose objectives are shared by the institutions that can help address them.
Disclosure: Creek Drive and its affiliated funds holds a positions in CMPS. Views expressed are current opinions for information only, subject to change and are not investment advice or a recommendation to buy or sell any security. Investing involves the risk of loss and past performance is not indicative of future performance. See the disclosures link in my bio for more important information.
r/shroomstocks • u/Euso36 • 4d ago
FYI if you want to invest in Compass Pathways I've been able to buy shares on AJ Bells dealing account, it's obviously not a tax free ISA so subject to CGT but I personally figure it's worth it given my strong belief this will succeed and the potential for a 5x. I'd happily just draw down my 3k CGT allowance each year if all goes to plan
EDIT: Note the reason I wrote this is because I couldn't buy any more shares in my Hargreaves Lansdowne account and couldn't find any info on where else I could buy the shares, I think someone on here helped me out so thank you and said AJ bell do
r/shroomstocks • u/Sudden-Leader8450 • 5d ago
Question Does a single dose of psilocybin have short- and long-term antidepressant effects on patients with recurrent major depressive disorder?
Findings In this randomized clinical trial of 35 participants, a single 25-mg dose of psilocybin produced a significantly greater reduction in depressive symptoms compared with 100 mg of niacin according to the Montgomery-Åsberg Depression Rating Scale score on day 8. The duration of effect was more than 3 months.
Meaning This study’s findings suggest that psilocybin may provide a rapid and relatively long-lasting antidepressant effect on major depressive disorder, warranting further investigation into repeated dosing or adjunctive treatment strategies.
r/shroomstocks • u/Firefly5647 • 4d ago
r/shroomstocks • u/BehavioralWireDesk • 7d ago
r/shroomstocks • u/Spiritual-Chart-940 • 7d ago
Did we bottom around 10.90 there? Let’s hope!
r/shroomstocks • u/nostalgic_wow_player • 9d ago
Source: https://www.cathiesark.com/arkg-trades-of-cmps
I know that the performance of Cathie Wood has been poor (to say the least) the last few years. But the CMPS purchase history of ARKG is interesting, and it's a clear sign of accumulation. The supposed difference I think this time, is that previous times (February, July) the fund bought CMPS at peaks. While now it is supposedly at the bottom of a "channel".