COGNITION THERAPEUTICS INC Stock Price, News & Analysis

Cognition Therapeutics (NASDAQ: CGTX), a clinical-stage company focused on neurodegenerative disorder treatments, has successfully regained compliance with Nasdaq's minimum bid price requirement. The company met Nasdaq's Rule 5550(a)(2) by maintaining a closing bid price of $1.00 or higher for at least 10 consecutive business days, achieving this milestone on August 25, 2025.

Following this achievement, Nasdaq has officially closed the bid price deficiency matter, confirming Cognition's continued listing on the exchange.

Cognition Therapeutics (NASDAQ: CGTX) has received FDA confirmation for its Phase 3 program design for zervimesine (CT1812) in Alzheimer's disease treatment. The FDA agreed that two six-month Phase 3 studies could support a New Drug Application (NDA).

The Phase 3 trials will focus on adults with mild-to-moderate Alzheimer's who have lower p-tau217 levels. Previous Phase 2 "SHINE" study showed that zervimesine achieved a 95% reduction in cognitive decline compared to placebo in this population. The studies will randomize participants to receive either 100mg daily oral zervimesine or placebo, with participants eligible for an open-label extension study upon completion.

Cognition Therapeutics (NASDAQ: CGTX) reported significant progress in its clinical programs for Q2 2025, particularly with its lead drug candidate zervimesine. The company achieved key milestones including surpassing 50% enrollment in Phase 2 'START' study for early Alzheimer's disease, reporting positive topline results in dry AMD with 28.6% reduction in GA lesion growth, and initiating an expanded access program for DLB patients.

Financial results showed cash position of $11.6 million with additional $41.9 million in NIA grant funds. Q2 2025 net loss was $6.7 million ($0.11 per share), improved from $7.0 million loss in Q2 2024. The company expects sufficient funding into Q2 2026.

Cognition Therapeutics (NASDAQ: CGTX) presented significant clinical data for their drug zervimesine (CT1812) at AAIC 2025, demonstrating positive results in both Dementia with Lewy Bodies (DLB) and Alzheimer's disease trials.

In the Phase 2 SHIMMER study, DLB patients treated with zervimesine showed 86% better scores than placebo on neuropsychiatric symptoms. The Phase 2 SHINE study in Alzheimer's revealed that patients with lower p-tau217 levels showed remarkable response, with cognitive deterioration arrested by 129% in mild cases and 91% in moderate cases.

Additional biomarker analyses showed significant reductions in plasma GFAP and promising trends in NfL and amyloid beta species, indicating zervimesine's impact on underlying disease biology.

Cognition Therapeutics (NASDAQ: CGTX) has published results from their Phase 2 'SEQUEL' study analyzing the proteomic effects of zervimesine (CT1812) in Alzheimer's disease patients. The study demonstrated that zervimesine treatment showed promising trends in normalizing brain electrical activity and improving communication between brain regions.

The research revealed that zervimesine helps preserve neuronal health under disease conditions by affecting proteins involved in vesicle formation, exocytosis, and endosomal trafficking. In vitro experiments showed that zervimesine protected neurons from oxidative stress-induced death, maintaining cellular integrity and preventing the release of neurofilament light (NfL) protein, a marker of neuronal damage.

These findings support previous results from the company's 'SHINE' Study and suggest a potential neuroprotective mechanism for zervimesine in treating Alzheimer's disease.

Cognition Therapeutics (NASDAQ: CGTX) announced significant positive results from their Phase 2 'SHIMMER' study of zervimesine (CT1812) in treating dementia with Lewy bodies (DLB). The drug demonstrated remarkable efficacy with treatment improvements of 86% in behavioral outcomes, 52% in daily living activities, 91% in cognitive fluctuations, and 62% in motor symptoms compared to placebo.

Additionally, in the Phase 2 'SHINE' study for Alzheimer's disease, zervimesine showed promising results, particularly in patients with lower p-Tau217 levels, demonstrating a 95% slowing of cognitive decline at six months compared to placebo. Dr. James E. Galvin will present these findings at the Alzheimer's Association International Conference (AAIC) on July 29, 2025.

Cognition Therapeutics (NASDAQ: CGTX) has completed a crucial end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812), their Alzheimer's disease treatment candidate. The meeting, held on July 9, 2025, focused on reviewing Phase 2 'SHINE' study results and discussing the proposed Phase 3 program requirements for a potential new drug application (NDA).

CEO Lisa Ricciardi indicated a positive outcome from the discussions, with the company expecting to receive the FDA's formal minutes in August 2025 to confirm their development pathway for zervimesine in Alzheimer's treatment.

Cognition Therapeutics (NASDAQ: CGTX) announced that its Phase 2 'START' Study of zervimesine (CT1812) for early Alzheimer's disease has achieved over 50% enrollment. The study, supported by an $81 million NIA grant, aims to enroll 540 individuals with mild Alzheimer's disease across approximately 50 U.S. sites.

The trial will evaluate zervimesine versus placebo over an 18-month treatment period. This milestone follows promising results from the Phase 2 'SHINE' Study, where zervimesine demonstrated a 38% reduction in cognitive decline compared to placebo, with particularly strong results (95% slowing of cognitive decline) in patients with lower p-tau217 levels.

The START Study is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC), focusing on patients just beginning to show signs of cognitive loss, who may potentially benefit most from treatment based on previous study outcomes.

Cognition Therapeutics (NASDAQ: CGTX) announced key regulatory developments for its drug zervimesine (CT1812). The company has scheduled an end-of-Phase 2 meeting with the FDA on July 9, 2025, to discuss results from the SHINE study in mild-to-moderate Alzheimer's disease and plans for Phase 3 trials.

Additionally, following positive Phase 2 SHIMMER study results, CGTX has submitted applications for both breakthrough therapy designation and IND approval for Dementia with Lewy Bodies (DLB). The company is also progressing with an expanded access program (EAP) for DLB patients, with high interest among former SHIMMER study participants.