Cognition Therapeutics Extends Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) extended its expanded access program (EAP) for zervimesine (CT1812) in dementia with Lewy bodies (DLB), allowing participants several additional months of treatment beyond the originally planned 12 months.
Thirty-two individuals are enrolled across eight sites, receiving 100 mg oral zervimesine daily. The company said the EAP, running since June 2025, aims to generate additional long-term safety data and reduced travel burdens by enabling local physician monitoring and local lab testing. Cognition held a Type C FDA meeting on January 21, 2026 to review SHIMMER findings; meeting minutes are expected in February.
Positive
- EAP extension provides additional long-term safety data collection
- Thirty-two participants enrolled across eight U.S. clinical sites
- Operational changes reduce patient travel by using local doctors and labs
- Consistent dosing: 100 mg oral zervimesine daily for all participants
- Type C meeting with FDA on January 21, 2026 to review SHIMMER
Negative
- Small sample size of 32 limits statistical generalizability
- Only eight clinical sites may constrain geographic patient access
- Key regulatory next steps rely on FDA meeting minutes expected in February
Market Reaction
Following this news, CGTX has gained 4.85%, reflecting a moderate positive market reaction. The stock is currently trading at $1.08. This price movement has added approximately $4M to the company's valuation.
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Key Figures
Market Reality Check
Peers on Argus
CGTX fell 8.04% with several biotech peers also down (e.g., TRDA -9%, TNYA -8.14%, TLSA -4.83%), but no sector-wide momentum flag from the scanner.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 27 | FDA Type C meeting | Positive | -4.3% | Reported productive FDA Type C meeting to plan Phase 2b DLB study. |
| Jan 06 | Phase 2 SHIMMER data | Positive | +0.7% | Published Phase 2 SHIMMER results showing safety and favorable DLB signals. |
| Dec 03 | EAP full enrollment | Positive | +11.8% | Announced full enrollment in DLB expanded access program with 100 mg dosing. |
| Dec 01 | Phase 3 AD plan | Positive | -7.5% | Presented Phase 3 registrational plan for Alzheimer’s disease at CTAD. |
| Nov 20 | Conference participation | Neutral | -4.3% | Announced CEO participation in Piper Sandler healthcare conference fireside chat. |
Recent positive clinical and FDA-related updates have produced mixed reactions: some DLB and Alzheimer’s announcements saw gains, while others sold off, indicating inconsistent trading responses to favorable news.
Over the past few months, Cognition has advanced zervimesine across dementia with Lewy bodies (DLB) and Alzheimer’s disease. The company reported positive Phase 2 SHIMMER DLB data on Jan 6, 2026 and a productive FDA Type C meeting on Jan 21, 2026, plus earlier full enrollment of the DLB expanded access program on Dec 3, 2025. It also outlined a Phase 3 Alzheimer’s plan on Dec 1, 2025 and participated in a healthcare conference on Nov 20, 2025. Today’s extension of the DLB expanded access program fits this ongoing clinical development trajectory.
Regulatory & Risk Context
An effective S-3 shelf filed on Dec 18, 2025 permits Cognition to offer up to $300,000,000 in various securities, including up to $75,000,000 of common stock via an at-the-market agreement with Jefferies. Proceeds are earmarked for general corporate purposes, including research, clinical development, working capital and capital expenditures.
Market Pulse Summary
This announcement extends the dementia with Lewy bodies expanded access program, keeping 32 participants on 100 mg daily zervimesine across 8 sites and emphasizing long-term safety data collection. It follows the Phase 2 SHIMMER results and a January 21, 2026 FDA Type C meeting on clinically meaningful endpoints. Investors may watch for the upcoming FDA meeting minutes and how extended real-world exposure from the program complements controlled Phase 2 findings in shaping future DLB studies.
Key Terms
expanded access program regulatory
dementia with lewy bodies medical
open-label medical
phase 2 medical
u.s. food and drug administration regulatory
AI-generated analysis. Not financial advice.
PURCHASE, N.Y., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, has extended the duration of the expanded access program (EAP) for dementia with Lewy bodies (DLB). The program, which was originally expected to provide each participant with twelve months of treatment, will now allow several more months of treatment.
“The EAP has been running since June 2025 and is expected to provide us with additional long-term safety data,” stated Anthony O. Caggiano, MD, PhD, Cognition's chief medical officer. “We’ve received favorable feedback during the program from participants and their care partners about their experience in this program. We implemented a strategy that reduces the amount of travel for patients to clinical sites by empowering their local physicians to conduct routine health monitoring and allowing local laboratory testing. Doctors and patients appreciate these operational aspects of the program.”
Thirty-two individuals were enrolled at eight sites in this open-label EAP, each of whom are being treated with 100 mg of oral zervimesine daily. Banner Sun Health Research Institute in Arizona was the first site to be activated and enrolled the first participants. David Shprecher, DO Msci is the primary investigator at Banner and provided feedback to the Cognition team during the design of the EAP.
“The Cognition team sought input from myself and other investigators in the design of this EAP to maximize the number of participants who could enroll with the limited resources available,” explained Dr. Shprecher. “With only eight clinical sites around the country able to participate, patients would need to travel long distances for clinic visits. Working together, we devised a system that would enable patients to see their local doctors for routine visits while traveling to clinic sites for more rigorous monitoring.”
The EAP is part of the company’s larger clinical development program in DLB, which included the Phase 2 SHIMMER study and planned clinical programs. Cognition Therapeutics conducted a Type C meeting with the U.S. Food and Drug Administration (FDA) on January 21, 2026 to review findings from the SHIMMER study. The meeting focused on the use of clinically meaningful endpoints in future studies of DLB. Meeting minutes are expected in February.
About the EAP
The COG1202 expanded access program (EAP) is an open-label program for eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the enrollment criteria. Dr. James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine is acting as lead investigator for the EAP. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. More information is available on clinicaltrials.gov under study identifier NCT06961760.
About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The Phase 2 START Study (NCT05531656) in early Alzheimer’s disease is ongoing. We believe zervimesine can regulate pathways that are impaired in these diseases through its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com.
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 and expanded access to zervimesine, any analyses of the results therefrom and our expectations regarding data and development programs for zervimesine, are forward-looking statements. These statements, including statements relating to the 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; 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.
FAQ
What change did Cognition Therapeutics (CGTX) make to the zervimesine DLB expanded access program on February 5, 2026?
How many patients and sites are in Cognition's zervimesine (CT1812) DLB EAP (CGTX)?
How does the EAP reduce travel burdens for dementia with Lewy bodies patients in CGTX's program?
What was discussed with the FDA regarding Cognition's DLB program and when did that meeting occur?
What dose of zervimesine are participants receiving in Cognition's DLB EAP (CGTX)?
