Cognition Therapeutics, Inc. announced the completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025, regarding zervimesine (CT1812) for Alzheimer's disease. The meeting's objective was to review results from the Phase 2 study and discuss plans for a Phase 3 program.
The company discussed the results from the Phase 2 'SHINE' Study in Alzheimer’s disease and its proposed Phase 3 plan with the FDA. Management stated that they believe they have a clear path forward for the development of zervimesine in the treatment of Alzheimer’s disease.
Cognition Therapeutics is now awaiting the FDA’s formal minutes, expected in August, to confirm the specific details of the path forward. This successful completion of a key regulatory interaction marks a significant step towards advancing zervimesine into pivotal trials.
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