FDA Meeting Clears Path for Zervimesine's Pivotal Study in Lewy Body Dementia Psychosis
CGTX has more than doubled off its 52-week low of $0.222.
Summary
Cognition Therapeutics announced a positive meeting with the FDA, establishing a clear path forward for a registrational study of its lead drug zervimesine (CT1812) in dementia with Lewy bodies (DLB) with psychosis. This follows the company's March announcements about advancing zervimesine for DLB psychosis and compelling Phase 2 data. This regulatory clarity is a significant de-risking event for the company's lead candidate, outlining the pathway towards potential market approval. The company anticipates reviewing the FDA's formal minutes in June, which should provide further details on the registrational program design.
At the time of this announcement, CGTX was trading at $1.21 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $115.5M. The 52-week trading range was $0.22 to $3.83. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.