FDA Agrees Psychosis Associated With Dementia With Lewy Bodies May Be Approvable Outcome, Reaches Alignment With Cognition Therapeutics On Vital Aspects To Support Its New Drug Application

Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and reached alignment with the Company on key aspects of a pivotal trial to support a New Drug Application (NDA). The registrational program is expected to begin in mid-2027.