Cognition Therapeutics Inc. ( CGTX ) shares jumped 30% to $1.43 in pre-market trading on Wednesday after the company announced FDA confirmation of its Phase 3 trial design for Alzheimer’s drug Zervimesine (CT1812).

Check out the current price of CGTX stock here. 

What Happened:  The New York-based clinical-stage biopharmaceutical company received final meeting minutes from the U.S. Food and Drug Administration confirming alignment on a registrational path for Zervimesine. The FDA indicated that the proposed Phase 3 program design may support a New Drug Application filing for the experimental Alzheimer’s treatment.

Lisa Ricciardi, president and CEO of Cognition Therapeutics ( CGTX ), stated, “Based on the end-of-Phase 2 meeting minutes, we are aligned with the FDA on a registrational plan for Zervimesine.”

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The FDA has indicated that two six-month Phase 3 studies could support a new drug application, allowing for faster enrollment and more cost-effective trials.

With a market capitalization of $80.70 million, CGTX has experienced significant volatility, trading between $0.22 and $1.29 over the past year. According to Benzinga Pro data, the neurodegeneration drug developer jumped 28.10% to $1.10 on Tuesday.

Why It Matters: The Phase 3 program of Cognition will enroll adults with mild-to-moderate Alzheimer’s disease who demonstrate lower p-tau217 levels at screening. Previous Phase 2 SHINE study results showed Zervimesine arrested cognitive deterioration by 95% compared to placebo in this specific patient population.

The enrichment strategy using plasma p-tau217 as a predictive biomarker aims to identify patients most likely to benefit from treatment.

Cognition Therapeutics ( CGTX ) has received approximately $111 million in National Institutes of Health grant support for its zervimesine development programs.

With a strong Momentum in the 82nd percentile, Benzinga’s Edge Stock Rankings indicate CGTX has a negative price trend across all time frames. Track the performance of other players in this segment.

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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.