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PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ:CGTX), a clinical-stage biotech company with a market capitalization of $63 million, announced Tuesday it has received final minutes from the FDA regarding its end-of-Phase 2 meeting for zervimesine (CT1812), an investigational treatment for Alzheimer’s disease. The news comes as the stock has shown strong momentum, delivering a 51% return over the past year according to InvestingPro data.
The FDA confirmed that the proposed Phase 3 program design could support a New Drug Application for zervimesine. According to the company, the Phase 3 studies will enroll adults with mild-to-moderate Alzheimer’s disease who have lower levels of p-tau217 at screening. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates it’s quickly burning through cash - a critical factor for investors monitoring clinical-stage biotech companies. Get access to 10+ additional exclusive ProTips and comprehensive financial analysis through InvestingPro.
The company stated that previous clinical experience showed zervimesine could arrest cognitive deterioration by 95% compared to placebo in this specific patient population. This biomarker-based approach is expected to enrich the study with patients most likely to benefit from treatment.
"In the meeting minutes, FDA concurred with our plan to enrich the Phase 3 study population with Alzheimer’s patients who have lower p-tau217," said Anthony Caggiano, Cognition’s CMO and head of R&D.
The Phase 3 program will randomize participants to either 100mg of oral zervimesine or placebo daily for six months. The FDA affirmed the efficacy and safety endpoints proposed by the company.
Lisa Ricciardi, president and CEO of Cognition, noted that one key outcome was "the FDA’s view that two six-month Phase 3 studies could support a new drug application for zervimesine."
Zervimesine is an oral, once-daily investigational drug being developed for central nervous system diseases including Alzheimer’s disease and dementia with Lewy bodies. The drug has been generally well tolerated in clinical studies to date, according to the company. With analysts setting price targets between $2 and $4 per share, suggesting significant potential upside, investors can access detailed valuation metrics and comprehensive analysis through the Pro Research Report, available exclusively on InvestingPro.
The announcement is based on a press release statement from Cognition Therapeutics.
In other recent news, Cognition Therapeutics, Inc. has reported positive results from its Phase 2 SEQUEL study of the drug zervimesine in adults with mild-to-moderate Alzheimer’s disease, showing promising effects on brain activity. Additionally, the company has completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding zervimesine, where they reviewed results from the Phase 2 SHINE study and discussed plans for a Phase 3 program. This meeting is part of Cognition’s efforts to support a New Drug Application for Alzheimer’s treatment. Furthermore, Cognition Therapeutics is set to present findings from its Phase 2 ’SHIMMER’ study of zervimesine for dementia with Lewy bodies at an upcoming Alzheimer’s Association International Conference. In related developments, H.C. Wainwright has reiterated its Buy rating for Cognition Therapeutics, maintaining a price target of $3.00. This decision follows the company’s recent discussions with the FDA and its progress in clinical trials. These recent developments are part of Cognition’s ongoing efforts in the field of neurodegenerative disease treatment.
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