Cognition Therapeutics (NASDAQ: CGTX) wins FDA alignment on pivotal DLB psychosis study for zervimesine
Rhea-AI Filing Summary
Cognition Therapeutics announced that the FDA provided written feedback aligning on key aspects of a pivotal Phase 3 trial of zervimesine (CT1812) for psychosis in dementia with Lewy bodies (DLB). The FDA agreed that DLB psychosis can be an approvable outcome to support a New Drug Application.
The planned registrational program is expected to begin in mid-2027 and will randomize people with DLB psychosis to receive 100 mg once-daily oral zervimesine or placebo for nine months, including patients on stable off-label antipsychotics. The company is working with the FDA to use the neuropsychiatric inventory (NPI) as a novel primary endpoint.
The study builds on Phase 2 SHIMMER data, where zervimesine showed improvements in psychosis symptoms versus placebo and, in a recent analysis, slowed progression of hallucinations and delusions by 89%. Cognition highlights a significant unmet need, noting that up to 80% of DLB patients experience psychosis and no drugs are currently approved for DLB.
Positive
- Regulatory alignment on pivotal trial: FDA agreed DLB psychosis is an approvable outcome and aligned with Cognition on key aspects of a Phase 3 registrational study for zervimesine (CT1812), providing a clearer pathway toward a potential New Drug Application.
Negative
- None.
Insights
FDA alignment on a pivotal DLB psychosis trial materially advances Cognition’s lead program.
The FDA’s agreement that DLB psychosis is an approvable outcome and its alignment on key Phase 3 design elements for zervimesine meaningfully clarifies the regulatory path. A defined registrational strategy often reduces development risk for a small clinical-stage company.
The anticipated mid-2027 start of a nine-month, once-daily 100 mg zervimesine study using the NPI as a novel primary endpoint ties the program directly to prior Phase 2 SHIMMER data, including the reported 89% slowing of hallucination and delusion progression. However, these findings remain preliminary and need confirmation in a larger, pivotal setting.
Cognition also references nearly $200 million in NIH and related foundation grants supporting its broader neurodegenerative pipeline, which may help sustain development. Future disclosures around final Phase 3 protocol details and execution will determine how effectively this alignment translates into an NDA-ready data package.
8-K Event Classification
Key Figures
Key Terms
New Drug Application (NDA) regulatory
Phase 3 study clinical
neuropsychiatric inventory (NPI) clinical
dementia with Lewy bodies (DLB) medical
United States Adopted Name (USAN) regulatory
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Item 8.01 Results of Operations and Financial Condition.
On June 24, 2026, Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the receipt of written feedback from the U.S. Food and Drug Administration (the “FDA”) following the Company’s recent meeting with the FDA in May. A copy of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are being furnished herewith:
| Exhibit No. |
Document | |
| 99.1 | Press Release, dated June 24, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| COGNITION THERAPEUTICS, INC. | ||
| Date: June 24, 2026 | ||
| By: | /s/ Lisa Ricciardi | |
| Name: | Lisa Ricciardi | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes
- 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, NY – June 24, 2026 – 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 is an approvable outcome and that key aspects of our registrational trial design are appropriate and supportive of an 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 89%. In July, the Company will present additional analyses from the Phase 2 study showing zervimesine’s impact on the hallucination and delusion components of the NPI at the Alzheimer’s Association’s International Conference (AAIC).
“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 $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com.
Cognition Therapeutics, Inc.
www.cogrx.com
About DLB Psychosis
Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. Up to 80% of people living with DLB experience psychosis, which manifests primarily as debilitating hallucinations and delusions. These symptoms are frequently cited as the most challenging for patients and their care partners to manage. There are no FDA-approved drugs for DLB, and the off-label use of traditional antipsychotics is often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need.
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 |
Cognition Therapeutics, Inc.
www.cogrx.com