Cognition Therapeutics Reaches Full Enrollment in Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Rhea-AI Summary
Cognition Therapeutics (NASDAQ: CGTX) announced its expanded access program for zervimesine (CT1812) in dementia with Lewy bodies has reached full enrollment. Each participant will receive 100 mg oral zervimesine daily for up to one year. The program enrollment was completed in three months and was enabled by a donation from a family of a Phase 2 SHIMMER study participant.
The company has aligned with FDA on a registrational program for Alzheimer’s disease and has scheduled a Type C meeting with FDA for the second half of January to discuss a proposed Phase 3 program in DLB; meeting minutes are expected after the meeting.
Positive
- Expanded access program reached full enrollment in three months
- Participants dosed with 100 mg oral zervimesine daily for up to one year
- Type C meeting with FDA scheduled for the second half of January to discuss Phase 3 design
Negative
- No efficacy or safety results for zervimesine in DLB were disclosed in the announcement
- Expanded access program was enabled by a single-family donation, indicating non‑recurring funding for the program
News Market Reaction
On the day this news was published, CGTX gained 11.80%, reflecting a significant positive market reaction. Argus tracked a peak move of +7.8% during that session. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $17M to the company's valuation, bringing the market cap to $160M at that time. Trading volume was above average at 1.8x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner showed 2 biotech peers moving down (median about -8.3%), while CGTX was up 0.6% pre‑news, suggesting stock‑specific rather than sector‑wide strength.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 03 | Expanded access update | Positive | +11.8% | Full enrollment of expanded access program and FDA Type C meeting scheduled. |
| Dec 01 | Phase 3 planning | Positive | -7.5% | Presented Phase 3 registrational plan for Alzheimer’s disease at CTAD conference. |
| Nov 20 | Conference participation | Neutral | -4.3% | CEO scheduled for fireside chat at major healthcare investor conference. |
| Nov 13 | Phase 2 enrollment | Positive | -10.5% | Completed enrollment of 540‑patient Phase 2 START study in early Alzheimer’s. |
| Nov 06 | Earnings and financing | Neutral | -1.8% | Q3 results, recent $30M financing, cash runway and program progress highlighted. |
Recent positive clinical and planning updates often saw negative price reactions, while today’s similar‑tone news coincided with a positive move.
Over the last month, Cognition reported multiple milestones for zervimesine (CT1812), including completion of Phase 2 START enrollment (540 participants) and presenting a Phase 3 Alzheimer’s plan. A Q3 2025 update highlighted a $30.0 million registered direct offering and cash plus grants supporting runway into Q2 2027. Despite earlier sell‑offs on seemingly positive clinical news (e.g., Phase 3 planning and Phase 2 enrollment), today’s full enrollment of the expanded access program and upcoming FDA Type C meeting in DLB drew a positive +11.8% reaction.
Market Pulse Summary
The stock surged +11.8% in the session following this news. A strong positive reaction aligns with this update’s clear clinical progression: full enrollment of the expanded access program and an FDA Type C meeting set for the second half of January. Historically, CGTX sometimes sold off on good news, such as Phase 3 planning and Phase 2 enrollment (moves of -7.47% and -10.47%). Investors should weigh that pattern, existing dilution from past financings, and execution risk around upcoming Phase 3 design discussions.
Key Terms
U.S. Food and Drug Administration (FDA) regulatory
expanded access program regulatory
Phase 2 medical
dementia with Lewy bodies (DLB) medical
Phase 3 medical
AI-generated analysis. Not financial advice.
- Type C Meeting with U.S. Food and Drug Administration (FDA) Scheduled for Second Half of January -
PURCHASE, N.Y., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that its expanded access program has reached full enrollment. Each of the individuals enrolled in the program are being treated with 100 mg of oral zervimesine daily for up to one year. The program was made possible through a generous donation from the family of a participant in the Phase 2 SHIMMER study of zervimesine (CT1812) in dementia with Lewy bodies (DLB).
“We are grateful to the family who made it possible to provide expanded access to zervimesine for people who were in the Phase 2 DLB study,” stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. “The efforts of our dedicated investigators and our clinical operations team made it possible to complete enrollment in only three months.”
“The speed with which the program was enrolled is also a testament to the high level of interest among patients with DLB,” added Lawrence S. Honig, MD, PhD, professor of neurology at Columbia University Irving Medical Center and an investigator in the program. “The ability to provide our patients with a medication that they feel is making a meaningful difference in their lives is incredibly rewarding. I look forward to working with Cognition on the next phase of clinical development for zervimesine.”
Having reached alignment with FDA on a registrational program for Alzheimer’s disease, Cognition Therapeutics is now pursuing similar input from the agency on DLB. The Company's request for a Type C meeting has been accepted by the U.S. Food and Drug Administration (FDA) and the meeting scheduled for the second half of January. The Type C meeting will focus on the proposed design of a Phase 3 program for zervimesine in this patient population. Meeting minutes are expected to follow the Type C meeting.
About the Expanded Access Program
The COG1202 expanded access program 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 multi-center, open-label program. 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 Zervimesine (CT1812)
Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to receptors on the surface of neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person’s ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. Zervimesine has been shown to interrupt the toxic effects of Aβ and ɑ-synuclein, which may slow progression of disease and improve the lives of those suffering from Alzheimer’s and DLB. 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.
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 zervimesine, any analyses of the results therefrom and our expectations regarding the 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 did Cognition Therapeutics (CGTX) announce on December 3, 2025 about zervimesine in DLB?
When is the FDA Type C meeting for CGTX about the proposed Phase 3 DLB program?
How quickly did CGTX complete enrollment for the zervimesine expanded access program?
What dose of zervimesine are participants receiving in the expanded access program?
Does the announcement provide Phase 3 trial design details for CGTX (CGTX) in DLB?
How was the expanded access program for zervimesine funded?
