Cognition Therapeutics To Conduct End-Of-Phase 2 Meeting With FDA For Mild-To-Moderate Alzheimer's Disease On July 9, 2025

- End-of-Phase 2 Meeting with FDA for Mild-to-Moderate Alzheimer's Disease Scheduled -

- Applications for IND and Breakthrough Status Filed for Dementia with Lewy Bodies -

PURCHASE, N.Y., June 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ:CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, 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 (NCT03507790) of zervimesine (CT1812) 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.

Breakthrough therapy designation is designed by the FDA to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions where preliminary clinical evidence suggests substantial improvement over existing treatments. The designation facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review. The FDA typically reviews applications for breakthrough designation within 60 days.

The expanded access program (EAP) for zervimesine in DLB is progressing with high interest among former SHIMMER participants. The EAP is enrolling adults with DLB who participated in the SHIMMER study, as well as others who meet the program's eligibility criteria. While one site is currently open, the Cognition team is working closely with other sites to complete onboarding so that they may be open to patients soon.