Cognition Therapeutics Inc. (NASDAQ:CGTX) saw its stock climb sharply by 75% following a productive end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) concerning its Alzheimer’s drug candidate.
On July 9, the clinical-stage biotech company engaged with FDA representatives to review the outcomes of its Phase 2 trial for zervimesine (CT1812) and to outline its proposed Phase 3 clinical program aimed at supporting a future new drug application.
“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 in the treatment of Alzheimer’s disease,” stated Lisa Ricciardi, Cognition’s president and CEO.
The company anticipates receiving official feedback from the FDA in August, which will confirm the regulatory path for advancing its Alzheimer’s treatment candidate.
Investor enthusiasm surged on the news, reflecting growing confidence in the drug’s development prospects and timeline following this important regulatory milestone.
Cognition Therapeutics continues to focus on developing therapies targeting cognitive impairments, with Alzheimer’s disease offering a significant opportunity given the scarcity of effective treatments for this progressive condition.
Cognition Therapeutics stock price
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