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Cognition Therapeutics, Inc. (NASDAQ: CGTX) is a clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related degenerative disorders of the central nervous system. Its news flow centers on the clinical and regulatory progress of its lead candidate, zervimesine (CT1812), an investigational oral pill in development for Alzheimer’s disease, dementia with Lewy bodies (DLB) and related conditions.
News updates from Cognition Therapeutics frequently cover milestones in its Phase 2 clinical programs. These include results and analyses from the SHINE study in mild-to-moderate Alzheimer’s disease, the SHIMMER study in mild-to-moderate DLB, and the START study in early Alzheimer’s disease. Articles describe safety and tolerability outcomes, changes in cognition and function measured by validated scales, and exploratory findings in behavioral, movement and neuropsychiatric domains.
Investors following CGTX news also see announcements about expanded access programs for zervimesine in DLB, collaborations with organizations such as the Alzheimer’s Clinical Trials Consortium, and substantial grant support from the National Institute on Aging of the National Institutes of Health. Regulatory and scientific updates, such as end-of-Phase 2 discussions with the U.S. Food and Drug Administration, Type C meeting plans, and presentations at major Alzheimer’s disease conferences, are regular features of the company’s news cycle.
In addition, Cognition Therapeutics issues press releases on financing transactions, including registered direct offerings of common stock and at-the-market equity programs, which provide context on how it funds ongoing and planned studies. For readers tracking CGTX, this news page consolidates clinical, regulatory, scientific and capital markets developments related to zervimesine and the company’s broader neurodegenerative disease pipeline.
Cognition Therapeutics (NASDAQ: CGTX) published Phase 2 SHIMMER results showing that oral zervimesine (CT1812) was safe and tolerated and produced favorable effects versus placebo across behavioral, cognitive, functional and movement measures in mild-to-moderate dementia with Lewy bodies (DLB).
The randomized study enrolled 130 participants who received daily dosing for six months. Zervimesine improved neuropsychiatric inventory (NPI) scores, reduced cognitive fluctuations, and improved activities of daily living versus placebo. Most treatment-related adverse events were reported as mild or moderate. A Type C meeting with the FDA is scheduled for the second half of January 2026 to discuss next DLB studies.
Cognition Therapeutics (NASDAQ: CGTX) announced its expanded access program for zervimesine (CT1812) in dementia with Lewy bodies has reached full enrollment. Each participant will receive 100 mg oral zervimesine daily for up to one year. The program enrollment was completed in three months and was enabled by a donation from a family of a Phase 2 SHIMMER study participant.
The company has aligned with FDA on a registrational program for Alzheimer’s disease and has scheduled a Type C meeting with FDA for the second half of January to discuss a proposed Phase 3 program in DLB; meeting minutes are expected after the meeting.
Cognition Therapeutics (NASDAQ: CGTX) presented a Phase 3 registrational plan for zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at CTAD on Dec 1, 2025. The company discussed design with the FDA during a July 2025 end-of-Phase 2 meeting and plans an EMA scientific advice meeting in February 2026 to align global strategy.
Key design elements: two randomized 1:1 six-month Phase 3 studies of 100 mg oral zervimesine daily, enrichment for patients with lower plasma p-tau217 at screening, efficacy measured by the iADRS, and eligibility for an open-label extension. Phase 2 SHINE data cited a 95% slowing of cognitive decline by ADAS-Cog11 in the lower p-tau subgroup versus placebo.
Cognition Therapeutics (Nasdaq: CGTX) announced that its president and CEO, Lisa Ricciardi, will participate in an "unplugged" fireside discussion at the 37th Annual Piper Sandler Healthcare Conference.
The event takes place December 2-4, 2025, with Cognition's presentation scheduled for Wednesday, December 3, 2025 at 4:30 p.m. ET. A live audio webcast will be available and an archived replay will be posted on the company investor relations site for 90 days after the event.
Cognition Therapeutics (NASDAQ: CGTX) announced completion of target enrollment for the randomized, placebo‑controlled Phase 2 START study of zervimesine (CT1812) in mild cognitive impairment and early Alzheimer’s disease, reaching 540 participants.
Approximately 50% of participants were enrolled during the last six months and ~15% of randomized participants were receiving background infusions of Leqembi (lecanemab) or Kisunla (donanemab). Topline results are expected after all participants complete 18 months of treatment.
Cognition Therapeutics (NASDAQ: CGTX) reported Q3 2025 results and program updates on Nov 6, 2025. The company completed a $30.0 million registered direct offering of 14,700,000 shares to fund next‑stage development of zervimesine (CT1812). Cognition said it achieved FDA alignment on a registrational path for zervimesine in Alzheimer’s disease and exceeded 75% enrollment in the Phase 2 START study. An expanded access program for dementia with Lewy bodies continues. Cash and equivalents were about $39.8 million with $36.3 million in remaining NIA grant funds; the company estimates runway into Q2 2027. Q3 net loss was $4.9 million (‑$0.06/share).
Cognition Therapeutics (NASDAQ: CGTX) announced that its Phase 2 'START' Study for zervimesine (CT1812) has achieved 75% enrollment of its target 540 participants with mild cognitive impairment (MCI) and early Alzheimer's disease. The study, conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) and funded by the National Institute of Aging, will evaluate the drug against placebo over an 18-month treatment period.
The company previously reported positive results from its SHINE Study in 2024, which demonstrated that zervimesine slowed cognitive deterioration in mild-to-moderate Alzheimer's patients with lower p-tau217 levels. The START Study aims to evaluate the drug's efficacy in earlier disease stages.
Cognition Therapeutics (NASDAQ: CGTX) has successfully closed a $30 million registered direct offering through the sale of 14.7 million shares of common stock at $2.05 per share to two new fundamental institutional investors, including a leading global investment firm.
The offering, managed by Titan Partners Group, will support the Phase 3 development of zervimesine (CT1812), the company's drug candidate for treating neurodegenerative disorders. CEO Lisa Ricciardi highlighted that this investment validates their positive data in three major age-related degenerative disorders.
The shares were offered under a previously filed and effective S-3 shelf registration statement, with the prospectus available through the SEC website and Titan Partners Group.
Cognition Therapeutics (NASDAQ: CGTX) has announced a $30 million registered direct offering of common stock, involving the sale of 14,700,000 shares to two new fundamental institutional investors, including a prominent global investment manager.
The offering is expected to close around August 29, 2025, with Titan Partners Group acting as the sole placement agent. The proceeds will fund the preparation of Phase 3 programs for zervimesine in neurodegenerative disorders, along with working capital and general corporate purposes.
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.
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