Cognition Therapeutics Receives Positive Feedback on Registrational Pathway during End-of-Phase 2 FDA Meeting for Zervimesine (CT1812) in Alzheimer’s Disease
DENVER, Colo., Jul 10, 2025 (247marketnews.com)- Cognition Therapeutics (NASDAQ:CGTX) completed of its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), yesterday. The meeting centered on reviewing data from the company’s Phase 2 clinical trial of zervimesine (CT1812) and discussing plans for a Phase 3 program aimed at supporting a future New Drug Application (NDA) for the treatment of Alzheimer’s disease. The dialogue with the FDA was constructive and provided positive guidance for advancing the registrational development of zervimesine.
Lisa Ricciardi, Cognition’s president and CEO, said, “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.”
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