Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) reported FDA alignment on key elements of a pivotal Phase 3 trial of zervimesine (CT1812) for psychosis in dementia with Lewy bodies (DLB). The FDA agreed DLB psychosis could be an approvable outcome, and the registrational program is expected to begin in mid-2027.
The planned study will randomize DLB patients with hallucinations and delusions to 100 mg once-daily oral zervimesine or placebo for nine months, allowing stable off-label antipsychotics. Cognition is working with FDA to use the neuropsychiatric inventory (NPI) as a novel primary endpoint, building on Phase 2 data where zervimesine slowed progression of hallucinations and delusions by 89%.
Positive
- FDA agrees DLB psychosis can be an approvable outcome for zervimesine
- Alignment with FDA on key design aspects of pivotal Phase 3 trial
- Registrational program for DLB psychosis expected to begin in mid-2027
- Phase 2 SHIMMER trial showed psychosis improvements on NPI versus placebo
- Phase 2 analysis reported 89% slowing of hallucinations and delusions progression
- Planned trial allows patients on stable off-label antipsychotic background therapy
Negative
- Pivotal registrational program not expected to start until mid-2027
- No drugs are currently approved for DLB psychosis; only off-label antipsychotics used
- Reliance on NPI as a novel primary endpoint may carry regulatory uncertainty
News Market Reaction – CGTX
In the Jun 24 session, CGTX declined 38.18%, reflecting a significant negative market reaction. Argus tracked a peak move of +4.9% during that session. Argus tracked a trough of -46.6% from its starting point during tracking. Our momentum scanner triggered 60 alerts that day, indicating high trading interest and price volatility. Trading volume was exceptionally heavy at 7.7x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 16 | Patent extension | Positive | +4.1% | USPTO allowance extending zervimesine composition-of-matter patent protection into 2045. |
| Jun 01 | Investor conferences | Positive | +5.9% | Planned investor conference appearances to discuss DLB psychosis registration plans. |
| May 21 | FDA meeting update | Positive | -3.1% | Reported productive FDA meeting on Phase 2 data and registrational trial design. |
| May 14 | Expanded access funding | Positive | +0.0% | Second philanthropic donation extending zervimesine expanded access treatment duration. |
| May 07 | Q1 earnings update | Positive | +4.3% | Q1 results with narrowed loss and cash runway into 2027 supporting clinical plans. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent CGTX news has more often prompted positive price reactions, though one constructive FDA update saw a selloff.
Key Terms
new drug application (nda) regulatory
neuropsychiatric inventory (npi) medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Zervimesine Would be the First Long-term, Durable Treatment Option with an Impact on Underlying Disease -
- Company Developing NPI as a Measure of DLB Psychosis -
PURCHASE, N.Y., June 24, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and reached alignment with the Company on key aspects of a pivotal trial to support a New Drug Application (NDA). The registrational program is expected to begin in mid-2027.
As discussed with the FDA, Cognition expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details for the use of the neuropsychiatric inventory (NPI) as a novel primary endpoint for a pivotal trial in DLB psychosis.
“We reached an important agreement with the FDA that DLB psychosis could be an approvable outcome and that key aspects of our registrational trial design are appropriate and supportive of a NDA,” explained Anthony O. Caggiano, MD, PhD, chief medical officer of Cognition. “To date, few drugs have been researched for DLB and none have been approved. The only recourse for DLB patients experiencing psychosis is the off-label use of potentially dangerous antipsychotics.”
The proposed Phase 3 study builds on findings from Cognition's Phase 2 COG1201 ‘SHIMMER’ trial in mild-to-moderate DLB, which demonstrated improvements in psychosis symptoms with zervimesine versus placebo as measured by the NPI. In a recent analysis of results from the Phase 2 study, zervimesine slowed progression of hallucinations and delusions by
“Working with the FDA, we intend to find a path forward for a patient population that has waited too long,” said Lisa Ricciardi, president and CEO. “Our ultimate goal is to provide patients and their families with a durable treatment option for DLB psychosis that actually slows the progression of hallucinations and delusions.”
About Cognition Therapeutics
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. The company’s lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. Backed by nearly
About DLB Psychosis
Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. Up to
About Zervimesine (CT1812)
Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date.
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statements relating to the study design, timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
| Contact Information: Cognition Therapeutics, Inc. info@cogrx.com | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
This press release was published by a CLEAR® Verified individual.
