COGNITION THERAPEUTICS INC Stock Price, News & Analysis

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.

Cognition Therapeutics (NASDAQ: CGTX) has received an anonymous donation to fund an expanded access program (EAP) for zervimesine (CT1812) in treating dementia with Lewy bodies (DLB). The donation comes from a family whose member was treated in the Phase 2 SHIMMER study. The EAP will initially accommodate about 30 patients who will receive 100 mg daily oral zervimesine for approximately one year. Dr. James Galvin from the University of Miami will lead the multi-center program, with Banner Sun Health Research Institute in Arizona as the first of eight activated sites. The program will be available to eligible SHIMMER study participants and new patients with mild-to-moderate DLB. Dr. David Shprecher will serve as the primary investigator at Banner Sun Health Research Institute.

Cognition Therapeutics (NASDAQ: CGTX) has released its tenth episode of the "Conversations" video podcast series focused on Dementia with Lewy Bodies (DLB). The two-part episode features caregivers Carla Preyer and Linda Szypula Ed.D., who were previously featured in the documentary "Facing the Wind," alongside medical experts Dr. Brendan Kelley from UT Southwestern Medical Center and Dr. Samantha K. Holden from the University of Colorado School of Medicine.

Part 1 explores caregiver challenges and distress in managing DLB patients, while Part 2 discusses the disease's fluctuating symptoms and measurement tools. The episode also provides insights into meaningful symptoms for patients and families, and how this information guides DLB clinical trial design.

Cognition Therapeutics (NASDAQ: CGTX) presented promising preclinical data for zervimesine (CT1812) at the Association for Research in Vision and Ophthalmology (ARVO). The data demonstrates the drug's potential to protect retinal cells in dry age-related macular degeneration (dry AMD). Key findings show that zervimesine binds to the TMEM97 receptor, regulating LDL uptake in retinal cells, and may protect against oxidized lipid damage. In a Phase 2 clinical trial with 100 participants, zervimesine showed a 28.6% reduction in GA lesion growth compared to placebo. The drug has also shown promise in Alzheimer's disease and dementia with Lewy bodies studies. Two posters presented at ARVO detailed the drug's mechanism in regulating retinal cell lipid uptake and protecting against cell damage.

Cognition Therapeutics (NASDAQ: CGTX) reported promising topline results from their Phase 2 MAGNIFY trial of zervimesine (CT1812) in treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The study demonstrated that zervimesine-treated patients showed 28.6% slower GA lesion growth and 28.2% smaller lesions at 18 months compared to placebo. The trial included approximately 100 participants, with 2/3 completing 12 months and 1/3 completing 18 months of dosing. As a once-daily oral treatment, zervimesine offers a potential alternative to current intravitreal injections, potentially transforming treatment accessibility. The company plans to present complete findings, including safety data and visual outcomes, at an upcoming medical meeting.

Cognition Therapeutics (NASDAQ: CGTX) reported its Q1 2025 financial results and provided key business updates. The company has requested an end-of-Phase 2 meeting with the FDA to review results from the SHINE study in Alzheimer's disease. Their Phase 2 'SHIMMER' study results in dementia with Lewy bodies (DLB) were accepted for presentation at AAIC 2025.

Financial highlights include: cash position of $16.4 million as of March 31, 2025, with $47.0 million in remaining NIH grant funds. Q1 2025 saw R&D expenses of $10.8 million and G&A expenses of $3.0 million. Net loss was $8.5 million ($0.14 per share), improved from $9.2 million ($0.27 per share) in Q1 2024. The company expects current cash to fund operations into Q4 2025.