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confidence high
sentiment neutral
materiality 0.60
Cognition Therapeutics advancing zervimesine for DLB psychosis after FDA Type C meeting
COGNITION THERAPEUTICS INC
- Company plans to pursue registrational path for zervimesine (CT1812) to treat DLB psychosis, following FDA Type C meeting minutes.
- Phase 2 SHIMMER data showed 86% slowing of decline on NPI-12 vs placebo; no motor function worsening.
- No approved medications for DLB psychosis; traditional antipsychotics are contraindicated.
- Next study will use validated endpoints for neuropsychiatric symptoms; patients randomized to 100 mg zervimesine or placebo.
- Company expects to meet with FDA Division of Psychiatry by midyear 2026 to discuss the program.