CMPS
COMPASS Pathways Plc
stockNASDAQADR

Positive $CMPS scenario

The FDA also granted Compass’s separate request for rolling review, allowing it to submit its New Drug Application in sections. I feel like CMPS is well positioned here, especially compared to Usona.

I think i directly addressed krakends' point by dismissing it. I dont think I ignored it - to expand on why I dismissed it, I just dont think even given an 8 month delay its feasible for Usona to meaningfully expand their data in such a way that they beat CMPS, which submitted complete data from the get go to the finish line. The presumption is that the delays are across the board and I think in the case of delays they would not be equally delayed. Usona's submission in progress would be met with many more questions and review phases than CMPS' complete submission. Im struggling to see a scenario revolving this news where CMPS is delayed but Usona isnt delayed more or rejected outright. That doesnt mean it doesnt exist, I just dont think I see it.

Few things after reading the whole thread here : The article is pretty clearly about them not handing out new vouchers. Nowhere does it say existing recipients get pulled off the fast track. Fact are that five drugs got approved after Makary left, several sped up by 8+ months. This can indicate the expedited reviews didn’t stop when the political council went dormant, the career scientists kept moving them. That’s the strongest evidence we’re probably fine for cmps That said, I’m not going to pretend it’s unambiguously good. The council that’s now dormant was described as having “a central role in speeding approvals.” Take that away and it’s reasonable to think the pace softens a bit. The Merck example mentioned, NDA accepted via rolling review and still waiting 3 months later, is the realistic picture imo. Still faster than standard, but maybe not the 30/60-day dream. On the Usona angle, Less political interference and a stricter science-led review probably does scrutinize Usona’s single trial harder than our two-trial package, so directionally yeah it’s not great for them. krakends made a fair point in here and it’s getting ignored: a slower clock actually helps Usona, because their long term follow up finishes around Feb 2027. But can they modify their nda once submitted ? but if they can it will take also more time to provide approval as fda has the review more data. Form CMPS I think voucher almost certainly intact, approval still coming and still faster than normal. There is a bunch of cmps firechatsoon so lets see if Compass comes out and says they’re getting a 6-month PDUFA, because they’d have to disclose that and it’d be an ugly day… Jefferies conference next week is probably where we get clarity. Until then anyone claiming they know for sure which way this goes is guessing

How is this bad news for the entire sector, including CMPS? It would clearly be good news for COMP360’s TRD program if it’s still part of this program since it extends the lead it will have over non CNPV drugs by 6 months or so. But I invested in these stocks before CNPV was even a thing, so it’s a non-issue for me.

Maybe you missed the other 4 companies that did still have their drugs approved within the expedited timeline since Makary left. Very good news for CMPS.

Yeah its difficult to know for certain but I think CMPS saying that they still anticipate the 1-2 month turn around is positive. It would be brutal for them if they had to wait 8 extra months given their current operational capacity is based on starting operations in mid 2027... having to start in 2028 would not be good for them financially

SLS, IOVA, ABCL, DRTS, CMPS

Idk how I missed that line. I read that as meaning the expedited timelines are in effect and are being overseen by career scientists rather than the political appointees that weee apparently overseeing it before. I posted a table showing that all the drugs that had vouchers and were approved after Makary left were approved on the expedited timeline (except for one that had some exceptional longstanding issues surrounding it). So I don’t see why it would be any different for CMPS.

"For the nine ​drugs still in the program, FDA career scientists have resumed overseeing review timelines, two sources said." In regards to how this effects CMPS this is the biggest sentence in the article and how its interpreted could be a couple of ways. The word "resumed" is very important because it can either imply that scientists had taken a step back and drugs were being forced through by political means only and that is now changing to have more stringent reviews for drugs already in the program OR that the review process itself has resumed for the nine drugs still in process and the timelines remain as previously stated. To clarify this we need transparency as to whether the timelines are still 1-2 months or if they are going to be extended out to the 10 month normal. The difference between these two VASTLY changes CMPS' anticipated timeline. Some pros and cons to both - if CNPV is essentially dead for existing drugs in the pipeline, I think this effectively kills Usona''s application because outside of political expediency i just dont see how they get approved with the depth of their dataset. If the expedited timelines still exist for drugs still in the program, then it does create a larger gap between CMPS' approval and subsequent companies because they would presumably all need to go through the 10 month process since the voucher program is effectively dead for new entrants. This creates more space between CMPS and DFTX or HELP...etc I think I lean towards the expedited approval still being in place being better for CMPS since personally I dont think Usona is actually a viable commercial threat and getting revenue started earlier, and creating a larger gap between the other companies far outweighs any threat by Usona. What do others think?

One thing to consider is that, even if this is worst case and it applies to companies already in the program, the company has been submitting modules—and the FDA has been reviewing them—for months now. We don’t have any indication that the 30-60 day timeline is nixed for CMPS, but even if it is, it should still be faster than usual due to the rolling review etc.

Lori said that prior to this article being leaked. For all we know, CMPS is finding out about this just as we are.

If that’s the whole article it doesn’t say the companies who already have a voucher will be halted, it seems as if there are just no more vouchers being handed out. And per usual the government never finishes what they start. Hopefully CMPS did enough and got in before the door closed.

Why is this positive for CMPS, they are shelving the program that supposed to give them short review times?

US FDA shelves fast-track priority voucher pilot program: Reuters Nov 12, 2026 at 6:23 AM ETEli Lilly and Company (LLY) Stock, MRK Stock, XLV, VHT, IHF, IHE, FXH, XLVI, FTXH, CMPS StockNVOBy: Arundhati Sarkar, SA News Editor2 Comments Detail of hands working in pharmaceutical factory The US Food and Drug Administration has shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary, Reuters reported, citing sources familiar with the matter and internal documents. Launched in June 2025, the Commissioner's National Priority Voucher program aimed to slash drug review timelines to just one to two months ​for therapies addressing national priorities, such as urgent unmet health needs. However, critics pointed to possible preferential treatment for companies meeting demands of President Donald Trump, like offering ‌drugs at lower prices. Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left the FDA in May. For several drugs, the program sped approval by eight months ​or more, the report said. However, no new drugs have gotten a voucher since Makary's departure, and a key component of the program — an executive council of political appointees that oversaw drug reviews ​and had a central role in speeding approvals — has gone dormant, internal documents show. The pilot had drawn fierce criticism from regulatory experts over the handpicking of drugs and makeup of the council, which included former acting drug center director Tracy Beth Hoeg and former biologics chief ​Vinay Prasad. Both left the FDA earlier this year. Companies were reportedly told by FDA leadership that the agency is not moving forward with the program but is ​keeping applications open. When companies submit them, they don't advance. Rich Danker, a former assistant secretary at the Department of Health and Human Services, said the initiative is quietly being phased out, pointing to the departure of the program's top administrator. No new vouchers have been awarded, he said. HHS spokesperson Emily Hilliard said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing on it to refine the ​framework, according to the report. Companies including Eli Lilly, Novo Nordisk (NVO) and Germany’s Merck received awards or vouchers after striking drug-pricing deals with the White House, with Merck securing a voucher for its fertility treatment Pergoveris.

SLS, GANX, IBRX, NRXP, HUMA, CMPS, DRTS, HELP

DRTS, IOVA, ABCL, SLS, CMPS

$CMPS (proprietary psilocybin for TRD) is missing from the list. It has no published PDUFA date yet, and PDUFA date doesn’t matter because they have CNPV. Final piece of rolling NDA submitted on 9th November, and CNPV timeline is 1-2 months until approval (before the clock starts, there might be 14-21 days from submitting until filing NDA, FDA might give a PDUFA date in 6 moths but they intend to beat it and still give approval in 1-2 months)

did one of these in the summer and a few people asked for the next round so here it is. Everything is under $10 and has an event the company itself has dated or guided inside roughly the next 3 months. If the company didn't say it, it's not on here. Quick thing first. All three PDUFAs this month land on a weekend. Nov 22 is a Sunday, Nov 28 is a Saturday, Dec 12 is a Saturday. FDA often acts on the business day before, so don't plan around Monday morning. The FDA dates SVRA (Savara), Nov 22. Molgramostim (Molbreevi) for autoimmune PAP. This was supposed to be Aug 22 and got pushed 3 months because FDA called their answers to info requests a major amendment. No safety or efficacy issue was cited, and that's the part I keep coming back to. Short interest is 31% of float which is a lot for a name going into a PDUFA. The catch is cash. Roughly $130M at end of September, call it 9 months at their burn. So approval or not I'd expect a raise at some point. PYPD (PolyPid), Nov 28. D-PLEX100 for preventing surgical site infections. Priority review. Their Phase 3 (SHIELD II) showed about a 60% relative risk reduction. Azurity has US rights and is talking early 2027 launch. Stock is already up 38% in 3 months so some of this is in the price. VNDA (Vanda), Dec 12. Imsidolimab for GPP (generalized pustular psoriasis). GEMINI-1 had 53% clear or almost clear at week 4 vs 13% on placebo. Spesolimab is the drug it gets compared to. Vanda is down about half this year which honestly makes the setup more interesting than the drug. Readouts guided for Q4 / year end SLS (Sellas). Hit the 80th event in the REGAL trial (GPS in AML) on Oct 28 and said topline comes this quarter. Stock dropped 18% that day which tells you how split people are. Overall survival endpoint, as binary as it gets. SI 29%. ANNX (Annexon). ARCHER II in geographic atrophy, 659 patients, Q4. The primary is stopping 15+ letter vision loss, which is a different bar than the approved GA drugs got through on. If it hits that's a real talking point. RGNX (Regenxbio). ATMOSPHERE and ASCENT with AbbVie, subretinal gene therapy in wet AMD, 1,200+ patients across both. Q4. Big partner, big trials, smallish stock. IMUX (Immunic). ENSURE-1 and ENSURE-2 in relapsing MS, 2,200 patients combined, guided by end of 2026. They already passed an interim futility look. Stock is down about half in 3 months so expectations aren't exactly high. Q3 report should be out any day, watch whether they repeat the timing. RZLT (Rezolute). upLIFT in tumor HI, small single arm study. 6 of the first 8 hit the primary at interim. But their congenital HI Phase 3 missed last December and people remember. H2 2026 guided. ACRS (Aclaris). Bosakitug (anti-TSLP) Phase 2 in atopic dermatitis, 109 patients, placebo controlled, Q4. Edge of the window, early 2027 AVIR (Atea). C-FORWARD in hep C. The North America trial already hit non-inferiority vs Epclusa in July, this is the second one, pushed from year end to early Q1 2027. Second trial after the first one already won is usually less drama. OLMA (Olema). OPERA-01, palazestrant in ER+/HER2- breast cancer, moved to Q1 2027 with enrollment done. 24% SI and down 68% this year. And CMPS isn't a readout, it's the rolling NDA for COMP360 in treatment resistant depression wrapping up this quarter. Slow burn one. What I'm avoiding Anything with a catalyst and no cash. DWTX has a Phase 2b readout guided for this quarter but had about $5M at end of September. That's 3 months. LGVN, SKYE and TVRD are all around 1 to 2 months of runway on their last filing and MBRX is basically zero. Good data and an offering the same morning is the most common way people lose money in this sector. Stuff that looked great on my list and wasn't EYPT showed up as a Q4 Phase 3 readout in wet AMD. Both trials already read out and missed, stock is down 97%. XFOR showed as Q4 too but the Phase 3 is now 2028. MPLT's schizophrenia Phase 2 was on my list and it already came out positive back in July. ZNTL was guided year end and quietly slid to first half 2027. So check the latest 10-Q or press release before you trust any calendar, including this one.

$CMPS comp360 psilocybin for TRD. NDA was submitted on 9th November, and they have a Commissioner’s National Priority Voucher with targeted 1-2 month FDA approval timeline!

CMPS

There were actually some interesting things in here that I haven’t heard before 1. IQVIA tracks prescriptions. So we’ll be able to see weekly how well COMP-360 is doing. 2. Voucher recipients don’t always get acceptance of NDA. So the idea that we’ll be able to tell if Usona actually submitted (I think it’s fairly certain that they did) based on the acceptance from FDA is not accurate. The next PR we get from CMPS could very well be approval. Would love to see it land before Christmas 3. They didn’t dodge the Usona question. Lori did a great job of reiterating that payers care about TRD datasets, and that the FDA has been consistent that they won’t lower standards. 4. Expecting prescriptions to start early Q3 or late Q2, still lots of caution about slow uptake despite demand.

DFTX AND HELP dropped less than CMPS. Factually. But maybe that only matters "if you are sub 30 years in old in age."

Why does it matter what molecule is used to treat MDD? They all are prescribed for the same condition and in competition with each other. How is this so difficult to understand? Your comment above “Just accept that there is a competitor that could cannibalise on CMPS sales. CMPS dropped because the overall market was unstable those days, plot a biotech sector ETF such as XBI vs CMPS charts and you'll see.. Jesus..” So which is it? Usona affected just Compass or the whole sector? Or idiots not understanding only Compass dropped due to the overall market and XBI? Like I said you are talking in circles and it doesn’t appear like you understand.

You assume the reporting is true, but it actually required a material correction a couple days later. So I wouldn’t assume anything in that regard. It’s been discussed widely in this sub but it wasn’t just this article. It’s a long standing sketchy pattern of reporting from him when it comes to Usona and especially when compared to CMPS.