Cognition Schedules Meeting with FDA for May 20, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
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"We filed a request to meet with the Food and Drug Administration's Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy body psychosis," stated Lisa Ricciardi, Cognition's president and CEO. "We recently received our meeting invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in this important indication."
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About CGTX
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. The Company is investigating its lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer’s disease. Its CT1812 and pipeline of sigma-2 modulators can regulate pathways that are impaired in these diseases for the treatment of degenerative diseases. Its lead product candidate, CT1812, is an orally delivered, small molecule designed to protect neuronal synapses by preventing the binding of oligomers of pathogenic proteins. Its pipeline candidates were discovered using proprietary biology and chemistry platforms designed to identify novel drug targets and disease-modifying therapies that address dysregulated pathways. It is developing other product candidates in the area of synucleinopathies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cognition Therapeutics Q1 Earnings Beat Expectations
- Earnings Performance: Cognition Therapeutics reported a Q1 GAAP EPS of -$0.05, beating expectations by $0.02, indicating improvements in financial management that may boost investor confidence.
- Cash Reserves: As of March 31, 2026, the company had approximately $31.2 million in cash, cash equivalents, and restricted cash, reflecting a healthy liquidity position that supports future operations and investments.
- Grant Funding: The remaining obligated grant funds from the National Institute on Aging total $25.6 million, providing crucial financial support for its R&D activities, potentially accelerating the development of new therapies.
- Operational Outlook: Cognition Therapeutics estimates sufficient cash to fund operations and capital expenditures through the second quarter of 2027, ensuring financial stability that underpins the company's strategic growth plans.
See More
Cognition Therapeutics CEO to Present at Needham Conference
- Conference Presentation: Cognition Therapeutics' CEO Lisa Ricciardi is scheduled to present at the 25th Annual Needham Virtual Healthcare Conference on April 13 at 3:00 PM ET, where she will provide updates on the company's development programs for Alzheimer's disease and dementia with Lewy bodies, likely drawing investor interest.
- Clinical Research Progress: The company's investigational drug CT1812 (zervimesine) has shown promising efficacy signals in Phase 2 trials for dementia with Lewy bodies and mild-to-moderate Alzheimer's disease, with plans to advance it into late-stage clinical trials to address the urgent market need for effective treatments.
- Funding Support Background: Cognition Therapeutics has secured nearly $200 million in grants from the National Institutes of Health and related foundations to support its clinical research in neurodegenerative diseases, highlighting the company's strong R&D capabilities and market potential within the industry.
- Innovative Drug Development: As the company's lead candidate, CT1812 aims to help millions of families by developing novel and accessible therapies, reflecting the company's strategic vision and social responsibility in addressing neurodegenerative diseases.
See More
Cognition Therapeutics Advances CT1812 to Late-Stage Trials for DLB Psychosis
- Clinical Trial Progress: Cognition Therapeutics is advancing zervimesine (CT1812) into late-stage trials for dementia with Lewy bodies (DLB) psychosis, with an $80 million Phase 2 START trial readout expected in the second half of 2027, indicating significant progress in the treatment of neurodegenerative diseases.
- SHIMMER Trial Results: At the International Lewy Body Dementia Conference, zervimesine demonstrated a favorable impact across various symptom domains in the SHIMMER trial, particularly in neuropsychiatric assessments, highlighting its potential in the DLB psychosis market and possibly driving future demand.
- Commitment to Alzheimer's Disease: The Phase 2 SHINE study for mild-to-moderate Alzheimer's disease showed zervimesine achieving cognitive decline reductions comparable to approved monoclonal antibodies, especially in participants with low p-tau217 levels, indicating its therapeutic potential.
- START Study Funding Assurance: The START study has fully enrolled 545 participants with mild cognitive impairment and early Alzheimer's disease, funded by NIH grants, and is expected to provide critical data for the second half of 2027, further advancing zervimesine's clinical development.
See More
Cognition Therapeutics Reports Better-Than-Expected FY GAAP EPS
- Earnings Highlights: Cognition Therapeutics reported a FY GAAP EPS of -$0.32, beating expectations by $0.07, indicating improvements in financial management and increased market confidence.
- Cash Position: As of December 31, 2025, the company had approximately $37.0 million in cash, cash equivalents, and restricted cash, demonstrating robust liquidity that supports future operations and investments.
- Grant Funding Status: The remaining obligated grant funds from the National Institute of Aging total $35.7 million, providing crucial financial support for the company's R&D and enhancing its competitive position in the biopharmaceutical sector.
- Funding Outlook: Cognition Therapeutics estimates that its current cash reserves are sufficient to fund operations and capital expenditures through the second quarter of 2027, indicating strong financial stability and growth potential over the next two years.
See More
Cognition Therapeutics Advances Zervimesine Clinical Development for DLB Psychosis
- Clinical Development Plan: Cognition Therapeutics plans to meet with the FDA Division of Psychiatry in mid-2026 to align on the registrational plan for zervimesine in treating DLB psychosis, addressing a significant unmet need in this patient population and highlighting its market potential.
- Trial Progress: The company has completed enrollment of 545 patients in the early Alzheimer's disease ‘START’ trial, with topline results expected in 2027, which will provide critical data for advancing zervimesine in Alzheimer's disease and potentially enhance its market acceptance.
- Improved Financial Position: As of December 31, 2025, the company reported approximately $37 million in cash and cash equivalents, a significant increase from 2024, indicating effective cash management that supports operations through the second quarter of 2027.
- Decrease in R&D Expenses: Research and development expenses for 2025 were $37.2 million, down from $41.7 million in 2024, primarily due to the completion of the SHINE and SHIMMER clinical trials, reflecting optimization in resource allocation.
See More
COGNITION THERAPEUTICS INC: FDA PSYCHIATRY DIVISION MEETING ANTICIPATED BY MID-2026
Cognition Therapeutics Meeting: Cognition Therapeutics is scheduled to meet with the FDA's Division of Psychiatry to discuss their developments and findings.
Timeline for Expectations: The meeting is anticipated to take place by mid-2026, indicating a timeline for potential advancements in their therapeutic approaches.
See More
Cognition Therapeutics Q1 Earnings Beat Expectations
- Earnings Performance: Cognition Therapeutics reported a Q1 GAAP EPS of -$0.05, beating expectations by $0.02, indicating improvements in financial management that may boost investor confidence.
- Cash Reserves: As of March 31, 2026, the company had approximately $31.2 million in cash, cash equivalents, and restricted cash, reflecting a healthy liquidity position that supports future operations and investments.
- Grant Funding: The remaining obligated grant funds from the National Institute on Aging total $25.6 million, providing crucial financial support for its R&D activities, potentially accelerating the development of new therapies.
- Operational Outlook: Cognition Therapeutics estimates sufficient cash to fund operations and capital expenditures through the second quarter of 2027, ensuring financial stability that underpins the company's strategic growth plans.
See More
Cognition Therapeutics CEO to Present at Needham Conference
- Conference Presentation: Cognition Therapeutics' CEO Lisa Ricciardi is scheduled to present at the 25th Annual Needham Virtual Healthcare Conference on April 13 at 3:00 PM ET, where she will provide updates on the company's development programs for Alzheimer's disease and dementia with Lewy bodies, likely drawing investor interest.
- Clinical Research Progress: The company's investigational drug CT1812 (zervimesine) has shown promising efficacy signals in Phase 2 trials for dementia with Lewy bodies and mild-to-moderate Alzheimer's disease, with plans to advance it into late-stage clinical trials to address the urgent market need for effective treatments.
- Funding Support Background: Cognition Therapeutics has secured nearly $200 million in grants from the National Institutes of Health and related foundations to support its clinical research in neurodegenerative diseases, highlighting the company's strong R&D capabilities and market potential within the industry.
- Innovative Drug Development: As the company's lead candidate, CT1812 aims to help millions of families by developing novel and accessible therapies, reflecting the company's strategic vision and social responsibility in addressing neurodegenerative diseases.
See More
Cognition Therapeutics Advances CT1812 to Late-Stage Trials for DLB Psychosis
- Clinical Trial Progress: Cognition Therapeutics is advancing zervimesine (CT1812) into late-stage trials for dementia with Lewy bodies (DLB) psychosis, with an $80 million Phase 2 START trial readout expected in the second half of 2027, indicating significant progress in the treatment of neurodegenerative diseases.
- SHIMMER Trial Results: At the International Lewy Body Dementia Conference, zervimesine demonstrated a favorable impact across various symptom domains in the SHIMMER trial, particularly in neuropsychiatric assessments, highlighting its potential in the DLB psychosis market and possibly driving future demand.
- Commitment to Alzheimer's Disease: The Phase 2 SHINE study for mild-to-moderate Alzheimer's disease showed zervimesine achieving cognitive decline reductions comparable to approved monoclonal antibodies, especially in participants with low p-tau217 levels, indicating its therapeutic potential.
- START Study Funding Assurance: The START study has fully enrolled 545 participants with mild cognitive impairment and early Alzheimer's disease, funded by NIH grants, and is expected to provide critical data for the second half of 2027, further advancing zervimesine's clinical development.
See More
Cognition Therapeutics Reports Better-Than-Expected FY GAAP EPS
- Earnings Highlights: Cognition Therapeutics reported a FY GAAP EPS of -$0.32, beating expectations by $0.07, indicating improvements in financial management and increased market confidence.
- Cash Position: As of December 31, 2025, the company had approximately $37.0 million in cash, cash equivalents, and restricted cash, demonstrating robust liquidity that supports future operations and investments.
- Grant Funding Status: The remaining obligated grant funds from the National Institute of Aging total $35.7 million, providing crucial financial support for the company's R&D and enhancing its competitive position in the biopharmaceutical sector.
- Funding Outlook: Cognition Therapeutics estimates that its current cash reserves are sufficient to fund operations and capital expenditures through the second quarter of 2027, indicating strong financial stability and growth potential over the next two years.
See More
Cognition Therapeutics Advances Zervimesine Clinical Development for DLB Psychosis
- Clinical Development Plan: Cognition Therapeutics plans to meet with the FDA Division of Psychiatry in mid-2026 to align on the registrational plan for zervimesine in treating DLB psychosis, addressing a significant unmet need in this patient population and highlighting its market potential.
- Trial Progress: The company has completed enrollment of 545 patients in the early Alzheimer's disease ‘START’ trial, with topline results expected in 2027, which will provide critical data for advancing zervimesine in Alzheimer's disease and potentially enhance its market acceptance.
- Improved Financial Position: As of December 31, 2025, the company reported approximately $37 million in cash and cash equivalents, a significant increase from 2024, indicating effective cash management that supports operations through the second quarter of 2027.
- Decrease in R&D Expenses: Research and development expenses for 2025 were $37.2 million, down from $41.7 million in 2024, primarily due to the completion of the SHINE and SHIMMER clinical trials, reflecting optimization in resource allocation.
See More
COGNITION THERAPEUTICS INC: FDA PSYCHIATRY DIVISION MEETING ANTICIPATED BY MID-2026
Cognition Therapeutics Meeting: Cognition Therapeutics is scheduled to meet with the FDA's Division of Psychiatry to discuss their developments and findings.
Timeline for Expectations: The meeting is anticipated to take place by mid-2026, indicating a timeline for potential advancements in their therapeutic approaches.
See More
