FDA Aligns on Pivotal Phase 3 Design for Cognition Therapeutics' Zervimesine in DLB Psychosis
CGTX has more than doubled off its 52-week low of $0.25.
Summary
Cognition Therapeutics has secured FDA alignment on the design of its pivotal Phase 3 trial for zervimesine in Dementia with Lewy Bodies (DLB) psychosis. The FDA also confirmed that DLB psychosis can be an approvable outcome for a New Drug Application. This follows previous positive FDA interactions in May and June regarding the drug's registrational path. This definitive agreement on trial design significantly de-risks the development of their lead candidate. The Phase 3 trial is anticipated to commence in mid-2027.
At the time of this announcement, CGTX was trading at $1.74 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $147.7M. The 52-week trading range was $0.25 to $3.83. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Wiseek News.