Cognition Therapeutics (CGTX) conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine and to discuss plans for a Phase 3 program that would support a new drug application for zervimesine as a treatment for Alzheimer’s disease. Lisa Ricciardi, CEO stated, “We discussed the results from the Phase 2 ‘SHINE’ Study in Alzheimer’s disease and our proposed Phase 3 plan with the FDA and believe we have a path forward for the development of zervimesine in the treatment of Alzheimer’s disease. We look forward to reviewing the FDA’s formal minutes in August to confirm our path forward.”
Claim 55% Off TipRanks
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CGTX:
- Cognition Therapeutics’ Promising Clinical Progress and Regulatory Advancements Justify Buy Rating
- Cognition Therapeutics announces Phase 2 ‘START’ study surpassed 50% enrollment
- Cognition Therapeutics Advances with CT1812 in Dementia Study
- Cognition to conduct end-of-Phase 2 meeting with FDA on zervimesine
- Cognition Therapeutics Holds Virtual Annual Stockholders Meeting
