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Cognition Therapeutics Completes End-of-Phase 2 Meeting with FDA for Zervimesine (CT1812) in Alzheimer’s Disease

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Cognition Therapeutics (NASDAQ: CGTX) has completed a crucial end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812), their Alzheimer's disease treatment candidate. The meeting, held on July 9, 2025, focused on reviewing Phase 2 'SHINE' study results and discussing the proposed Phase 3 program requirements for a potential new drug application (NDA).

CEO Lisa Ricciardi indicated a positive outcome from the discussions, with the company expecting to receive the FDA's formal minutes in August 2025 to confirm their development pathway for zervimesine in Alzheimer's treatment.

Cognition Therapeutics (NASDAQ: CGTX) ha concluso un incontro cruciale di fine Fase 2 con la FDA riguardo a zervimesine (CT1812), il loro candidato terapeutico per l'Alzheimer. L'incontro, tenutosi il 9 luglio 2025, si è concentrato sulla revisione dei risultati dello studio di Fase 2 'SHINE' e sulla discussione dei requisiti proposti per il programma di Fase 3, in vista di una possibile domanda di nuovo farmaco (NDA).

La CEO Lisa Ricciardi ha indicato un esito positivo delle discussioni, con l'azienda che si aspetta di ricevere i verbali ufficiali della FDA entro agosto 2025 per confermare il percorso di sviluppo di zervimesine nel trattamento dell'Alzheimer.

Cognition Therapeutics (NASDAQ: CGTX) ha completado una reunión crucial de fin de Fase 2 con la FDA sobre zervimesine (CT1812), su candidato para el tratamiento de la enfermedad de Alzheimer. La reunión, celebrada el 9 de julio de 2025, se centró en revisar los resultados del estudio de Fase 2 'SHINE' y discutir los requisitos propuestos para el programa de Fase 3, de cara a una posible solicitud de nuevo medicamento (NDA).

La CEO Lisa Ricciardi indicó un resultado positivo en las discusiones, y la empresa espera recibir las actas formales de la FDA en agosto de 2025 para confirmar su camino de desarrollo de zervimesine para el tratamiento del Alzheimer.

Cognition Therapeutics (NASDAQ: CGTX)가 알츠하이� � 치료 후보물질� zervimesine(CT1812)� 대� FDA와 중요� 2� 종료 미팅� 완료했습니다. � 미팅은 2025� 7� 9�� 열렸으며, 2� 'SHINE' 연구 결과 검토와 잠재적인 신약 신청(NDA)� 위한 3� 프로그램 요구사항� 대� 논의했습니다.

CEO 리사 리치아디� 논의 결과가 긍정적이었다� 밝혔으며, 회사� 2025� 8�� FDA� 공식 회의록을 받아 zervimesine� 알츠하이� 치료 개발 경로� 확정� 것으� 기대하고 있습니다.

Cognition Therapeutics (NASDAQ : CGTX) a achevé une réunion cruciale de fin de phase 2 avec la FDA concernant zervimesine (CT1812), leur candidat traitement contre la maladie d'Alzheimer. La réunion, tenue le 9 juillet 2025, s'est concentrée sur l'examen des résultats de l'étude de phase 2 'SHINE' et la discussion des exigences proposées pour le programme de phase 3 en vue d'une éventuelle demande de nouveau médicament (NDA).

La PDG Lisa Ricciardi a indiqué un résultat positif des discussions, l'entreprise s'attendant à recevoir le procès-verbal officiel de la FDA en août 2025 afin de confirmer leur trajectoire de développement pour zervimesine dans le traitement de l'Alzheimer.

Cognition Therapeutics (NASDAQ: CGTX) hat ein entscheidendes End-of-Phase-2-Meeting mit der FDA bezüglich zervimesine (CT1812), ihrem Kandidaten zur Behandlung der Alzheimer-Krankheit, abgeschlossen. Das Treffen fand am 9. Juli 2025 statt und konzentrierte sich auf die Überprüfung der Ergebnisse der Phase-2-Studie 'SHINE' sowie die Diskussion der Anforderungen für das vorgeschlagene Phase-3-Programm im Hinblick auf eine mögliche Zulassungsanmeldung (NDA).

CEO Lisa Ricciardi zeigte sich mit dem Ergebnis der Gespräche zufrieden, und das Unternehmen erwartet, im August 2025 das offizielle Protokoll der FDA zu erhalten, um den Entwicklungsweg für zervimesine bei der Alzheimer-Behandlung zu bestätigen.

Positive
  • Successful completion of end-of-Phase 2 meeting with FDA
  • Management indicates positive discussions regarding Phase 3 pathway
  • Clear timeline for receiving FDA's formal minutes in August
Negative
  • Phase 2 study results not disclosed in the announcement
  • Specific Phase 3 program details not yet confirmed

Positive Discussion on Path Forward for Registrational Program

PURCHASE, N.Y., July 10, 2025 (GLOBE NEWSWIRE) -- , (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine as a treatment for Alzheimer’s disease.

, president and CEO of Cognition, stated, “We discussed the results from the Phase 2 ‘SHINE� Study in Alzheimer’s disease and our proposed Phase 3 plan with the FDA and believe we have a path forward for the development of zervimesine in the treatment of Alzheimer’s disease. We look forward to reviewing the FDA’s formal minutes in August to confirm our path forward.”�

About Zervimesine (CT1812)
(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 the SHINE Study
The was a double-blind, placebo-controlled Phase 2 study that enrolled 153 adults with mild-to-moderate Alzheimer’s disease. The study met its primary endpoints of safety and tolerability. Changes in cognition (ADAS-Cog 11, cognitive composite and MMSE) and function (ADCS-ADL and ADCS-CGIC) were also measured. Participants were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months.

The SHINE Study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. More information may be found at clinicaltrials.gov under trial ID .

About 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 () in early Alzheimer’s disease is ongoing with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. We believe zervimesine can regulate pathways that are impaired in these diseases though 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 .

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 the enrollment of patients in the EAP for DLB, as well as statements regarding our regulatory plans, including our end-of-Phase 2 meeting, our plans for a Phase 3 program, and our expectations regarding the IND and breakthrough designation status for zervimesine for the treatment of DLB, 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; 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 theSecurities & 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.
[email protected]
Casey McDonald (media)
Tiberend Strategic Advisors, Inc.
[email protected]
Mike Moyer (investors)
LifeSci Advisors
[email protected]

This press release was published by a CLEAR® Verified individual.


FAQ

What was the outcome of Cognition Therapeutics' (CGTX) FDA meeting for zervimesine?

Cognition Therapeutics completed an end-of-Phase 2 meeting with the FDA on July 9, 2025, indicating a positive discussion regarding the path forward for zervimesine's Phase 3 program in Alzheimer's disease treatment.

When will CGTX receive formal FDA feedback for zervimesine's Phase 3 program?

Cognition Therapeutics expects to receive the FDA's formal minutes in August 2025 to confirm their development pathway for zervimesine.

What is the purpose of zervimesine (CT1812) by Cognition Therapeutics?

Zervimesine (CT1812) is being developed as a potential treatment for Alzheimer's disease by Cognition Therapeutics.

What was discussed in CGTX's end-of-Phase 2 meeting with the FDA?

The meeting focused on reviewing results from the Phase 2 'SHINE' study and discussing plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine in Alzheimer's treatment.

Who is leading Cognition Therapeutics' zervimesine development program?

Lisa Ricciardi, president and CEO of Cognition Therapeutics, is leading the company's development program for zervimesine.
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Biotechnology
Biological Products, (no Disgnostic Substances)
United States
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