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PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ:CGTX), a $33 million market cap biotech company whose stock has surged over 30% in the past week, announced Thursday it has completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding its Alzheimer’s disease drug candidate zervimesine. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt.
The meeting, held on Wednesday, focused on reviewing results from the Phase 2 "SHINE" study and discussing plans for a Phase 3 program that would support a new drug application for zervimesine as an Alzheimer’s treatment. While the company’s current share price suggests overvaluation based on InvestingPro’s Fair Value analysis, its financial health score remains fair, with liquid assets exceeding short-term obligations by a ratio of 2.09.
"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," said Lisa Ricciardi, president and CEO of Cognition. The company expects to receive formal minutes from the FDA in August.
The SHINE study was a double-blind, placebo-controlled trial that enrolled 153 adults with mild-to-moderate Alzheimer’s disease. Participants received either placebo or one of two doses of zervimesine (100 mg or 300 mg) orally for six months. The study met its primary endpoints of safety and tolerability, according to the company’s press release.
Zervimesine is an investigational oral, once-daily pill being developed for central nervous system diseases including Alzheimer’s disease and dementia with Lewy bodies. The drug is designed to interrupt the toxic effects of proteins that accumulate in the brain during these diseases.
The SHINE study received approximately $30 million in grant funding from the National Institute on Aging of the National Institutes of Health. Cognition is also conducting the Phase 2 START study in early Alzheimer’s disease with $81 million in NIA grant support.
Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for age-related degenerative disorders of the central nervous system. While analysts maintain a strong buy consensus with price targets ranging from $2 to $4, InvestingPro analysis reveals the company is rapidly burning through cash. Get access to 10+ additional ProTips and comprehensive financial analysis with an InvestingPro subscription, including the detailed Pro Research Report available for CGTX and 1,400+ other US stocks.
In other recent news, Cognition Therapeutics has announced significant progress in its Phase 2 START Study for early Alzheimer’s disease, surpassing 50% enrollment. The study, which evaluates the oral drug zervimesine, aims to enroll up to 540 individuals across approximately 50 U.S. sites, supported by $81 million in grant funding from the National Institute of Aging. H.C. Wainwright has maintained its Buy rating on Cognition Therapeutics, with a price target of $3.00, following this milestone. In related developments, Cognition Therapeutics is advancing its zervimesine drug for dementia with Lewy bodies (DLB) and has received an anonymous donation to fund an expanded access program for this condition. This program will initially accommodate around 30 individuals, with plans to expand based on funding and drug availability.
Additionally, Cognition Therapeutics has shared results from its Phase 2 COG2201 MAGNIFY trial, showing that zervimesine slowed the growth of geographic atrophy lesions in patients with dry age-related macular degeneration. Despite promising findings, the company will not continue zervimesine’s development for this condition at present, opting to conserve resources. The trial was concluded early with around 100 participants, though the data suggests potential for future exploration. H.C. Wainwright adjusted its price target for Cognition Therapeutics to $3 from $5, reflecting anticipated equity dilution expected to extend the company’s operational runway.
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