Cognition to conduct end-of-Phase 2 meeting with FDA on zervimesine

Cognition Therapeutics (CGTX) announced that the company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA, on July 9, 2025. During the meeting, the Cognition team will review results of the Phase 2 ‘SHINE’ study of zervimesine in mild-to-moderate Alzheimer’s disease. In addition, proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population will be discussed with the FDA. “We believe we have a compelling proposal to advance zervimesine into a Phase 3 registrational program for mild-to-moderate Alzheimer’s disease,” stated Lisa Ricciardi, Cognition’s president and CEO. “In parallel we are moving ahead with DLB and formulating plans to conduct a registrational program. Based on the positive Phase 2 ‘SHIMMER’ study results in DLB, we submitted an application to be considered for breakthrough therapy designation along with the investigational new drug application.”