CGTX news

Latest 4 stories · newest Oct 22, 2026

CGTX
Cognition announces FDA alignment on pivotal Phase 3 trial design for zervimesine

Cognition Therapeutics (CGTX) announced that the FDA has aligned on key elements for its pivotal Phase 3 study in Dementia with Lewy Bodies (DLB), targeting participants with mild-to-moderate forms of the no-approved-treatments disease.

CGTX
FDA agrees to key aspects of pivotal trial design for zervimesine

Cognition Therapeutics received FDA feedback agreeing that DLB psychosis is an approvable outcome and aligning on its Phase 3 trial design. This regulatory milestone paves the way for the first durable treatment for the condition, potentially replacing dangerous off-label antipsychotics.

CGTX
Cognition Therapeutics presents zervimesine advancement toward registrational development

Cognition Therapeutics presented investigational oral therapy zervimesine for DLB psychosis at Jefferies Global Healthcare Conference, advancing toward registrational clinical development. The company is progressing its lead candidate through clinical trials with expectations to replicate initial po…

CGTX
Cognition Therapeutics completes positive FDA meeting on zervimesine registrational program for DLB psychosis.

Cognition Therapeutics held a productive meeting with the FDA on May 20, 2026 to discuss Phase 2 results for zervimesine (CT1812) in dementia with Lewy bodies with psychosis and obtain guidance on advancing into late-stage trials. The positive discussion on the path forward is encouraging for the co…

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