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Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB)
- 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
About this update from Cognition Therapeutics, Inc.
[{"type":"image","alt":"Cognition Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Cognition Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":250,"height":70,"url":"https://media.zenfs.com/en/globenewswire.com/cc90d0cfc1ad93cdee05813266446f22"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/3G97CJjBroOGRUYevL.t.A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/cc90d0cfc1ad93cdee05813266446f22","width":250,"height":70}},"lazy":false},{"type":"text","content":"- End-of-Phase 2 Meeting with FDA for Mild-to-Moderate Alzheimer’s Disease Scheduled -","length":86,"tagName":"p"},{"type":"text","content":"- Applications for IND and Breakthrough Status Filed for Dementia with Lewy Bodies -","length":84,"tagName":"p"},{"type":"text","content":"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.","length":671,"tagName":"p"},{"type":"text","content":"“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 (NCT05225415) results in DLB, we submitted an application to be considered for breakthrough therapy designation along with the investigational new drug (IND) application.”","length":518,"tagName":"p"},{"type":"text","content":"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 ov...