USFDAMay 21, 2026, 07:41 AM
Cognition Therapeutics Completes Positive FDA Meeting for Zervimesine
AI Summary
Cognition Therapeutics announced the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) regarding its drug candidate, zervimesine (CT1812), for dementia with Lewy bodies (DLB) patients with psychosis. The discussions focused on the results from the Phase 2 SHIMMER study and the proposed plan to advance zervimesine into a registrational program. The company believes it has a clear path forward for the drug's development and anticipates reviewing the FDA's formal minutes in June.
Key Highlights
- Cognition Therapeutics completed a positive meeting with the FDA for zervimesine (CT1812).
- Discussions focused on zervimesine for dementia with Lewy bodies (DLB) patients with psychosis.
- The company believes there is a clear path forward for a registrational program.
- The meeting reviewed results from the Phase 2 COG1201 'SHIMMER' Study in DLB.
- Cognition Therapeutics expects to receive the FDA's formal minutes in June.
- Zervimesine is also being studied in the Phase 2 START Study for MCI and early Alzheimer’s disease.
- The company's research is supported by nearly $200 million in NIH and related foundation grants.
Price Impact
More from CGTX