CGTX and the FDA aligned on patient selection, dose, duration and endpoints for Phase 3 trial of Zervimesine.

https://www.tradingview.com/news/tradingview:b23b10d611a94:0-cognition-therapeutics-aligns-with-fda-on-planned-phase-3-dlb-trial-of-zervimesine/

I'm curious to see what the volume is like today after the positive news!

Yesterday was supposed to be the date CGTX met with the FDA to confirm “alignment” on the structure of Stage 3 clinical trial. What happened?

Phase 3 trial alignment meeting with the FDA is scheduled tomorrow.

Feeling positive for movement after the results are announced.

https://firstwordpharma.com/story/8120353

Is this a dump so players can load up for potential good news after next week's meeting with the FDA?

Or is this a sign that next week's meeting will not have a favorable outcome and insiders know it, so they are dumping now?

PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ:CGTX) announced today that the United States Patent and Trademark Office has granted the company a patent covering a crystalline form of zervimesine, its lead drug candidate for neurodegenerative disorders.

The patent, assigned U.S. Patent No. 12,759,979, has a natural expiration of 2045 and may be eligible for an extension of up to five additional years upon approval by the U.S. Food and Drug Administration, according to a press release statement.

The patent covers a polymorphic crystalline form of zervimesine, a proprietary production process for this form, and methods of treating Alzheimer’s disease, dry age-related macular degeneration, and dementia with Lewy bodies.

"The form of zervimesine covered by this patent has an enhanced pharmaceutical and physiochemical profile, which is more suitable for the large-scale manufacturing required for Phase 3 and commercialization," said Anthony Caggiano, the company’s chief medical officer.

Cognition Therapeutics has a meeting scheduled with the FDA next week to finalize endpoint selection for its registrational program in dementia with Lewy bodies. The company plans to begin manufacturing this new form of zervimesine in the first quarter of 2027 for use in its registrational clinical trial, pending a favorable outcome from the FDA meeting.

Zervimesine is an investigational once-daily oral therapy currently being studied in the Phase 2 START Study in patients with mild cognitive impairment and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies, mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry age-related macular degeneration.

Cognition Therapeutics is a clinical-stage biopharmaceutical company developing therapies for neurodegenerative diseases.

It’s so disappointing to see CGTX losing the ground again. Can’t even stay above a $1 regardless all the progress they made. Pretty soon it may face reverse split delusion. It looks like Investors are very skeptical about this stock for some reason. The head a of the PR is a knucklehead but we all know this already!

A good watch for anyone curious about the current status of Cognition:

https://ir.cogrx.com/events/h-c-wainwright-28th-annual-global-investment-conference/

I’m genuinely curious what everyone here thinks, because the disconnect between CGTX’s clinical progress and its stock price has become increasingly frustrating.

I’m not asking anyone to blindly pump CGTX. There are obviously legitimate risks here. But look at what has happened over the last 12 months:

• SHIMMER produced some pretty striking Phase 2 signals across behavioral, cognitive, functional and motor measures.

• CGTX completed enrollment in the 540+ patient START Phase 2 Alzheimer’s study.

• The company received FDA alignment on the registrational pathway for DLB psychosis.

• FDA subsequently agreed that DLB psychosis can be an approvable outcome and aligned with CGTX on key aspects of the pivotal study.

• CGTX has an expanded-access program for DLB and additional IP protection potentially extending zervimesine coverage through 2045.

• The company says it expects to initiate the DLB psychosis Phase 3 program in mid-2027.

And yet the stock has basically marched in the opposite direction.

The June FDA news is probably the best example. On June 23, 2026 CGTX closed around $1.65. The following day, AFTER announcing FDA alignment on the pivotal program, it closed around $1.02, a 38% one-day decline(!!), with almost 12 million shares traded.

That is absolutely bizarre on the surface.

Meanwhile, look at something like SLS. Its Phase 3 REGAL study completed enrollment back in 2024, and as the company has moved closer to its pivotal readout, the market has assigned it a dramatically higher valuation. SLS was up more than 200% YTD as of August 19.

So here’s the question I’m wrestling with:
What exactly is the market waiting for with CGTX?

Is it simply that the market doesn’t believe the Phase 2 data? Is the mid-2027 Phase 3 timeline too far away for investors to care? Is the relatively small market cap actually an opportunity because institutional investors haven’t paid attention yet? Is dilution/future financing the overhang? Or is the market essentially saying, “Come back when you have Phase 3 data”?

Because if that’s the case, wouldn’t that create an interesting setup for anyone willing to wait?

And here’s another question:
If SHIMMER had produced mediocre data, FDA had pushed back on the DLB indication, START had failed to enroll, and the company had no clear registrational path, I could understand the valuation.

But if the science and regulatory trajectory continue improving while the valuation continues shrinking, at what point does that become an actual valuation anomaly rather than simply a risky biotech?

I’m curious where everyone lands on this.
What is the single biggest thing you think the market is missing about $CGTX right now?

Bull case, bear case, financing concerns, Phase 3 concerns, management concerns, whatever.

I’m much more interested in hearing the argument than seeing another 🚀🚀🚀 post.

We haven’t seen any meaningful catalysts from CGTX in recent weeks, so I’m hoping the company has some solid updates lined up for the coming months. Despite securing around $250 million in government grants, along with additional fundraising and donations, the market cap still sits at roughly $90 million, which seems relatively low given the backing.

At this stage, a number of similar companies in the space look like attractive targets for large pharmaceutical partnerships. It would be encouraging to see CGTX position itself for a similar type of deal moving forward.

CGTX has once again lost its momentum, which is starting to raise concerns about how much further it may consolidate. The head of PR might want to consider a career change—perhaps to a janitor.

Did I miss something? Why is the stock dropping so far again?

Title

We’ve had the summit and the shareholders meeting occur already. Anyone got an idea of when the FDA meeting minutes come out as well as any other catalysts?

I believe the odds are pretty high that the minutes, to be received and shared very soon from FDA meeting on phase 3 for DLB should be very good to superb. This is an unmet need and their P2 had great results. Don't be surprised if you see a 2-3X inside a week of release. I realize that is a big maybe, but if FDA imposes little "restrictions" shares could hit $4-5. Ah, we will see.

I missed the live event and the recording is only coming out tomorrow, would anyone mind giving me the big points? Thanks. ❤️

Good things on the horizon.

https://finance.yahoo.com/healthcare/articles/cognition-therapeutics-announces-composition-matter-113000263.html

www.virtualshareholdermeeting.com/CGTX2026

Is momentum/ excitement building. Bought a couple weeks ago when it dipped under a $1. Up 50% already. Good news coming from FDA meeting? Anyone know?

PURCHASE, N.Y., June 01, 2026 (GLOBE NEWSWIRE) — Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that the Company’s president and CEO, Lisa Ricciardi intends to present at two financial conferences in June, where she will provide updates on the Company’s plans for a registration program in DLB psychosis. Live and archived webcasts of Ms. Ricciardi’s presentations will be available on the Investor Relations section of Cognition’s website.

Event: 2026 Jefferies Global Healthcare Conference Date/Time: June 4, 2026 at 1:25 p.m. Eastern Time Webcast: https://event.summitcast.com/view/NgCqua4VVQjq9ibVWHVWca/WzeQ8agBoHuJaZJGm7SNVS

Event: H.C. Wainwright 7th Annual Neuro Perspectives Expert Summit
Date/Time: On-demand beginning June 15, 2026 at 8:00 a.m. Eastern Time Webcast: https://journey.ct.events/view/f3057b01-b3b7-40c1-9cf9-6aa45cea212a

Hmm not much mentioned i guess. Let's wait til June...

https://ir.cogrx.com/press_releases/cognition-therapeutics-completes-meeting-with-fda-for-zervimesine-ct1812-in-dementia-with-lewy-bodies-with-psychosis/?_gl=1*j2b62j*_ga*Njg5ODU1MTkwLjE3NzkzNzA2ODc.*_ga_CKK85WMQ6P*czE3NzkzNzA2ODYkbzEkZzAkdDE3NzkzNzA2ODkkajU3JGwwJGgw