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Investing.com - H.C. Wainwright reiterated its buy rating and $3.00 price target on Cognition Therapeutics (NASDAQ:CGTX) stock ahead of a key regulatory meeting. The biotech company, currently trading at $0.30 per share, has seen its stock decline over 80% in the past year. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $2.00 to $4.00.
The company announced Wednesday that it will hold an end-of-Phase 2 meeting with the FDA on July 9, 2025, to review results from the Phase 2 SHINE study of zervimesine in mild-to-moderate Alzheimer’s disease. During this meeting, Cognition will also discuss proposed plans for a Phase 3 program designed to support regulatory approval. InvestingPro analysis shows the company maintains a healthy balance sheet with more cash than debt and a current ratio of 2.09, though it’s currently burning through cash reserves.
Cognition Therapeutics is simultaneously advancing zervimesine for dementia with Lewy bodies (DLB) and developing plans for a registrational program. Following positive Phase 2 SHIMMER study results in DLB, the company submitted applications for Breakthrough Therapy Designation along with an Investigational New Drug application. Get deeper insights into CGTX’s financial health and growth prospects with a comprehensive Pro Research Report, available exclusively on InvestingPro.
The FDA typically reviews Breakthrough Therapy Designation applications within 60 days. This designation was created to expedite development and regulatory review of promising therapies for serious conditions where preliminary clinical evidence suggests substantial improvement over existing treatments.
An expanded access program for zervimesine in DLB is currently enrolling former SHIMMER study participants and other eligible patients. While one site is currently operational, the company is working to complete onboarding at additional locations.
In other recent news, Cognition Therapeutics announced several developments regarding its lead drug candidate, zervimesine. The company reported promising results from its Phase 2 MAGNIFY trial, which indicated a 28.6% slower growth rate of geographic atrophy lesions in dry age-related macular degeneration patients treated with zervimesine. Despite these results, Cognition has chosen to pause further development for this condition to conserve resources. Additionally, the company disclosed findings from its Phase 2 SHINE study, showing reductions in key Alzheimer’s disease biomarkers in patients treated with zervimesine. These results were particularly notable in a subgroup with lower levels of the protein p-Tau217. Meanwhile, Cognition Therapeutics has received an anonymous donation to fund an expanded access program for dementia with Lewy bodies, utilizing zervimesine. H.C. Wainwright has maintained a Buy rating for the company, though it adjusted the stock’s price target to $3, citing anticipated equity dilution. The firm highlighted the clinical potential of zervimesine in its ongoing programs. These developments underscore Cognition’s strategic focus on neurodegenerative disorders.
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