Cognition Therapeutics Soars 61.65% on Positive FDA Meeting

Cognition Therapeutics' stock surged 61.65% in pre-market trading on July 10, 2025, driven by significant developments in its Alzheimer's disease treatment candidate, zervimesine (CT1812).

The company recently completed an end-of-Phase 2 meeting with the FDA, focusing on the results of the Phase 2 'SHINE' study and discussing plans for a Phase 3 program. The meeting, held on July 9, 2025, was crucial for reviewing the safety and efficacy data of zervimesine, which is being developed to treat Alzheimer's disease and dementia with Lewy bodies (DLB).

CEO Lisa Ricciardi expressed optimism about the outcome, stating that the discussions with the FDA provided a clear path forward for the development of zervimesine. The company is awaiting the FDA's formal minutes in August 2025 to confirm the development pathway for zervimesine in Alzheimer's treatment.

Zervimesine (CT1812) is an investigational, oral, once-daily pill designed to interrupt the toxic effects of proteins associated with Alzheimer's and DLB, potentially slowing disease progression and improving patients' lives. The Phase 2 'SHINE' study, which enrolled 153 adults with mild-to-moderate Alzheimer's disease, met its primary endpoints of safety and tolerability, with positive changes observed in cognition and function.