Latest news with #DLB
Yahoo
7 days ago
- Health
- Yahoo
Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC
- Zervimesine-treated participants tested 86% better on behavioral outcomes (NPI 12), 52% on activities of daily living, 91% on cognitive fluctuations, and 62% on motor symptoms as compared to placebo - - Additional presentations highlight positive clinical and biomarker effects of zervimesine in the low p-tau217 population in Phase 2 Alzheimer's disease study - PURCHASE, N.Y., July 16, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that James E. Galvin, MD, MPH will present results from the Phase 2 'SHIMMER' study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer's Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025 in the 8:00 a.m. ET Featured Research Session. 'The results of the Phase 2 SHIMMER study give hope to the millions of people living with DLB and their healthcare teams, who struggle to treat this complex disease,' stated Dr. Galvin. 'My colleagues and I believe that there is great potential in a once-daily oral medication that slows disease progress while simultaneously reducing the severity and frequency of some of the most troublesome symptoms of DLB.' DLB is the second most common cause of dementia, affecting approximately 1.4 million Americans. People living with DLB experience a variety of symptoms, which typically include neuropsychiatric features such as hallucinations, delusions and agitation; cognitive impairment; Parkinsonian movement disorders; REM sleep behavior disorder; and fluctuations in attention and awareness. Currently no disease-modifying therapeutics are approved for DLB. Anthony Caggiano, MD, PhD, Cognition's CMO and head of R&D added, 'Zervimesine's broad neuroprotective mechanism is illustrated by the favorable results observed in the Phase 2 SHIMMER study in DLB. In the SHIMMER study, zervimesine treatment slowed the progression of DLB's diverse symptomology, with a meaningful impact on neuropsychiatric, motor, functional, and cognitive measures. Results from the Phase 2 'SHINE' study in people with Alzheimer's disease add further evidence to zervimesine's neuroprotective properties. We look forward to presenting results from both studies at AAIC.' The SHINE study was a signal-finding trial that showed zervimesine treatment preserved cognitive and functional abilities better than placebo in people with mild-to-moderate Alzheimer's disease. This impact was more robust in participants with lower levels of p-Tau217, who experienced a 95% slowing of cognitive decline at six months as measured by ADAS-Cog 11 compared to placebo. Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer's study at AAIC. Dr. Galvin's slide presentation as well as Cognition's three posters will be available on the Cognition Therapeutics website in accordance with the conference's embargo policy. Cognition at AAIC: Featured Research Session: • Baseline Characteristics and Results of the Phase 2 COG1201 SHIMMER Study of Zervimesine (CT1812): 8:00-8:45 a.m. on July 29 Posters: • Zervimesine (CT1812) Treatment Benefits Patients with Lower Baseline Plasma p-tau217 Across the Mild-to-Moderate AD Spectrum: (#106858) July 27 • Exploratory CSF proteomic analysis of a pre-specified pTau217 subgroup from the SHINE clinical trial identifies biomarkers correlated with cognitive improvement in Alzheimer's disease patients treated with zervimesine: (#102120) July 27 • An exploratory proteomics plasma biomarker analysis of the SHIMMER Phase 2 clinical trial to assess the pharmacodynamic effect of the sigma-2 receptor modulator zervimesine in dementia with Lewy bodies patients: (#106855) July 27 About the SHIMMER Study in Dementia with Lewy BodiesThe SHIMMER study (COG1201; NCT05225415) is an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. A total of 88 participants were randomized to the two treatment arms and 42 to the placebo arm. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism. The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). About the SHINE Study in Mild-to-Moderate Alzheimer's Disease The SHINE study (NCT03507790) is a double-blind, placebo-controlled Phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease who were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months. The primary endpoint was safety and tolerability. The key secondary endpoint of cognition was ADAS-Cog 11. Exploratory endpoints included change in MMSE, ADAS-Cog 13, ADCS-ADL and -CGIC as well as pre-specified subgroup analyses included a comparison of cognitive and functional changes in participants with plasma p-tau217 levels above and below the median. The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. About Zervimesine (CT1812)Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer's disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person's ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer's and DLB. Zervimesine has been generally well tolerated in clinical studies to date. Zervimesine has been granted FDA Fast Track designation in Alzheimer's disease. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. About Cognition Therapeutics, Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We believe zervimesine and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our future clinical development plans, and statements regarding our clinical trials of zervimesine and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'seek,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'forecast,' 'potential' or 'continue' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the 'Risk Factors' section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Casey McDonald (media)Tiberend Strategic Advisors, Mike Moyer (investors)LifeSci Advisorsmmoyer@ This press release was published by a CLEAR® Verified individual.
Business Insider
13-07-2025
- Business
- Business Insider
AMC Jumps 11% after First Analyst Buy in 4 Years – Is Analyst Sentiment Turning?
Shares of AMC Entertainment (AMC) surged 11% on Thursday after Wedbush five-star analyst Alicia Reese upgraded the stock to Outperform and raised her price target to $4. It's the first Buy rating the company has received from a major Wall Street analyst in over four years. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. The upgrade comes as AMC shows signs of progress in key areas. Reese pointed to a stronger film slate ahead, market share gains driven by premium screens, and a cleaner balance sheet following recent debt restructuring. Investors responded quickly to the bullish note, pushing the stock to $3.33 at the close and $3.34 in after-hours trading. What Changed? Wedbush cited several tailwinds supporting the upgrade. First, AMC recently completed a major debt restructuring that pushes most maturities to 2029 and beyond. The move reduced near-term uncertainty and included $143 million of debt converted into equity. Second, AMC continues to leverage its premium screen leadership, owning the largest footprint of IMAX (IMAX) and Dolby (DLB) theaters in North America, to attract moviegoers despite the rise of streaming. Reese also sees growth potential from planned expansions in the UK and EU. Lastly, the analyst noted that AMC is approaching the end of its share issuance cycle. With EBITDA now expected to cover interest expenses, the need for further equity raises could be off the table. What This Means for Investors In the near term, the stock may see continued volatility as investors weigh short squeezes, sentiment swings, and upcoming earnings. But in the medium term, the narrative appears to be shifting. The focus is moving from meme-driven spikes to actual balance sheet improvements and steady box office trends. Is AMC Stock a Buy? The average 12-month price target on AMC currently stands at $3.10, implying a 6.91% downside. Price targets range from a low of $2.60 to a high of $4. Despite Wedbush's renewed belief in AMC, only 1 out of 8 analysts now rates the stock a Buy, while 6 remain at Hold and 1 at Sell. TipRanks AI rates the stock as Hold with a $3.50 target, reflecting a more cautious 5.1% upside.
Malaysian Reserve
10-07-2025
- Health
- Malaysian Reserve
Comprehensive Lewy Body Dementia Market Analysis of Evolving Trends and Anticipated Growth Trajectory During the Forecast Period (2025-2034)
According to DelveInsight's analysis, the Lewy body dementia market is anticipated to increase during the forecast period (2025–2034), owing to the launch of emerging therapies such as Neflamapimod (CervoMed), Zervimesine (Cognition Therapeutics), Nilotinib (KeifeRx), and others, and healthcare spending in the 7MM. LAS VEGAS, July 10, 2025 /PRNewswire/ — Lewy body dementia (LBD) is a progressive neurological condition characterized by the accumulation of abnormal alpha-synuclein protein in the brain. This buildup leads to cognitive impairments, visual hallucinations, Parkinson-like motor symptoms, and fluctuating attention levels. LBD encompasses two main subtypes: Dementia with Lewy bodies (DLB), where cognitive issues arise before or at the same time as motor symptoms, and Parkinson's Disease Dementia (PDD), in which dementia appears more than a year after the onset of motor symptoms. While both share the same underlying pathology involving alpha-synuclein, they differ based on the sequence of symptom development. Diagnosis is primarily clinical, supported by cognitive assessments, neuroimaging, and sleep evaluations, although definitive diagnosis is possible only post-mortem. Treatment is symptom-oriented and includes cholinesterase inhibitors, selective use of Parkinson's medications, and interventions for psychiatric and sleep disturbances, though care must be taken not to worsen cognitive issues. According to DelveInsight, there were around 12 million diagnosed cases of dementia across the 7MM in 2024, with expectations of significant growth through 2034, driven by a rising CAGR. According to DelveInsight's 2024 analysis, approximately 330K diagnosed prevalent cases of DLB were reported in the US, emphasizing the significant disease burden in one of the world's key pharmaceutical markets. This substantial patient population underlines the urgent need for improved diagnostic tools and effective treatment options within the US healthcare landscape. Download the report to understand which factors are driving Lewy body dementia epidemiology trends @ Lewy Body Dementia Treatment Algorithm Currently, LBD has no approved disease-modifying therapies (DMTs), and existing treatments offer only partial symptomatic relief. These are often limited by side effects or may worsen certain symptoms. The complexity of managing overlapping cognitive, motor, and psychiatric issues underscores the urgent need for more effective, targeted, and better-tolerated therapies to improve quality of life for patients. Lewy body dementia presents with a distinctive mix of cognitive, motor, and psychiatric symptoms. Existing treatments tend to address these symptoms individually and often fall short in effectiveness. There is a pressing need for therapies that target multiple symptoms simultaneously or are customized to LBD's underlying neurobiology, offering more comprehensive and lasting care. Patients with LBD are particularly vulnerable to adverse drug reactions, especially from antipsychotics, which can cause severe, even life-threatening side effects. This drug sensitivity severely limits treatment options and adds complexity to clinical management. Safer, more tolerable therapies that alleviate neuropsychiatric symptoms without worsening cognition or motor function are critically needed. Currently, there are no dependable, non-invasive biomarkers to confirm an LBD diagnosis during life. Diagnosis relies mainly on clinical presentation, which often results in misdiagnosis or delayed recognition. A validated biomarker would enhance early and accurate diagnosis, aid in identifying appropriate patient groups, and facilitate clinical trial participation, advancing the development of targeted treatments. Learn more about the Lewy body dementia treatment @ New Treatment for Lewy Body Dementia As the current Lewy body dementia market is marked by a notable lack of approved treatment options, it presents a significant opportunity for the introduction of new therapies. This shortfall highlights the urgent need for innovative drugs that can address the disease's intricate pathology. With limited competition and a strong unmet medical need, companies developing treatments in this area may find a favorable environment. The LBD drug development pipeline remains relatively sparse, with only a handful of pharmaceutical companies actively working on targeted therapies. Although the demand for effective treatments is increasing, innovation is still in its early stages. Promising investigational candidates such as Neflamapimod, Zervimesine, and Nilotinib have shown potential in addressing the multifaceted symptoms of LBD, indicating early progress toward bridging the significant therapeutic gap. Discover which therapies are expected to grab major Lewy body dementia market share @ Lewy Body Dementia Market Report Neflamapimod, an investigational central nervous system (CNS) therapy developed by CervoMed and originally licensed from Vertex Pharmaceuticals, has been granted Fast Track designation (FTD) by the FDA for the treatment of dementia with Lewy bodies (DLB). The drug has exhibited a strong safety profile in over 350 patients and promising efficacy in Phase II studies. CervoMed holds multiple patents for its use and formulation, protecting 2039. Initial proof-of-concept data was released in Q1 2025, with additional results expected in the second half of 2025. A Phase III trial is anticipated in mid-2026, contingent on regulatory feedback and funding. In June 2025, CervoMed announced a strategic hire to bolster the development and commercialization of neflamapimod, along with efforts to reinforce Chemistry, Manufacturing, and Controls (CMC) leadership in preparation for scaling up production. Zervimesine (CT1812) is under investigation for mild-to-moderate DLB. The Phase IIa SHIMMER trial (COG1201) it demonstrated a favorable safety profile and consistent efficacy signals across behavioral, cognitive, functional, and motor areas, with benefits increasing over six months. These results support its continued development. Nilotinib, originally approved by Novartis for a different indication, is being repurposed for Parkinson's disease dementia (PDD). Acting as a c-ABL and DDR-1 inhibitor, it is currently in Phase II trials aiming to enhance protein clearance and mitigate neurodegeneration. Preliminary findings suggest improvements in both cognition and motor skills. KeifeRx is collaborating on Nilotinib's clinical assessment and sees promise in its potential as a disease-modifying therapy for neurodegenerative diseases. KeifeRx is also advancing KFRX05, another candidate for PDD, currently in the IND-enabling stage. Discover more about drugs for Lewy body dementia in development @ Lewy Body Dementia Clinical Trials The anticipated launch of these emerging therapies for Lewy body dementia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Lewy body dementia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for Lewy body dementia is expected to grow at a significant CAGR by 2034. This growth is mainly driven by increased awareness, improved diagnostic capabilities, and an aging global population. The lack of disease-modifying therapies has created a strong demand for novel treatment options. Ongoing clinical trials targeting alpha-synuclein pathology are attracting significant investment. Additionally, regulatory support is accelerating therapeutic development in this underserved neurodegenerative space. DelveInsight's latest published market report, titled as Lewy Body Dementia Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the Lewy body dementia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The Lewy body dementia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Dementia Total Diagnosed Prevalent Cases of LBD Gender-specific Diagnosed Prevalent Cases of LBD Type-specific Diagnosed Prevalent Cases of LBD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Lewy body dementia market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this Lewy body dementia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the Lewy body dementia market. Also, stay abreast of the mitigating factors to improve your market position in the Lewy body dementia therapeutic space. Related Reports Lewy Body Dementia Pipeline Lewy Body Dementia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key FCS companies, including EIP Pharma Inc., Cognition Therapeutics, Eisai Inc., Sun Pharma Advanced Research Company Limited, Georgetown University, Eli Lilly and Company, CuraSen Therapeutics, Inc., Athira Pharma, Aptinyx Inc., among others. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies including Eisai Co., Ltd., Eli Lilly and Company, Novartis AG, DAIICHI SANKYO COMPANY, LIMITED, AbbVie Inc., Lundbeck, Biogen, Cipla, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies including AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol-Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC, among others. Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur [email protected] +14699457679 Logo: View original content:
Yahoo
09-07-2025
- Business
- Yahoo
CervoMed Strengthens Leadership with Technical Operations Hire to Advance Neflamapimod Toward Phase 3
CervoMed Inc. (NASDAQ:CRVO) is one of the best-performing NASDAQ stocks according to analysts. On June 10, CervoMed announced a significant addition to its senior leadership team. Dr. Marco Verwijs, PhD, joined CervoMed in June this year as Executive Vice President, Technical Operations. The strategic hire is intended to support the company's Chemistry, Manufacturing, and Controls/CMC division. This hire will also support the advancement of neflamapimod through Phase 3 testing and preparation for commercial manufacturing, as Dr. Verwijs brings extensive experience in drug development, spanning from the pre-clinical stage through NDA submissions and commercial launch. Before joining CervoMed, he served as CTO at Adipo Therapeutics. His expertise includes a particular focus on drug product and process development, scale-up, and validation, as well as overseeing supply chain and quality assurance. A biopharmaceutical research laboratory filled with scientists, illuminated by the glow of their equipment. Neflamapimod is an investigational and orally administered small-molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. It is being developed to potentially treat synaptic dysfunction, which is a reversible aspect of the neurodegenerative processes underlying DLB and other major neurological disorders. CervoMed Inc. (NASDAQ:CRVO) is a clinical-stage biotechnology company that develops and commercializes treatments for age-related neurologic disorders. While we acknowledge the potential of CRVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
03-06-2025
- Business
- Yahoo
Philanthropic Donor Funds Cognition Therapeutics' Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies
Dr. James Galvin of the University of Miami to Serve as Lead Investigator First Site Initiated: Banner Sun Health Research Institute PURCHASE, N.Y., June 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the 'Company' or 'Cognition') (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced today it has received an anonymous philanthropic donation to substantially fund an expanded access program (EAP) for people with dementia with Lewy bodies (DLB). The generous donation comes from the family of a DLB patient who was treated with zervimesine in the Phase 2 SHIMMER study. Through this open-label EAP, participants will be provided with 100 mg of oral zervimesine to take daily for approximately one year. Banner Sun Health Research Institute in Arizona is the first of eight sites to be activated, with David Shprecher, DO Msci serving as primary investigator at the site. 'At Cognition, our ultimate goal is to create a therapy that changes lives. We are moving as rapidly as possible to onboard participating sites so that we can begin providing zervimesine to eligible patients this month,' stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. 'Throughout the SHIMMER study, we have enjoyed a collaborative relationship with Drs. Galvin and Shprecher and their staffs. Their commitment and that of the Cognition team has been instrumental in launching the EAP so rapidly. Cognition would like to extend our sincere thanks to the benefactor and all stakeholders who made this program a reality.' Dr. James E. Galvin, MD, MPH, will act as lead investigator for the multi-center, open-label EAP. Dr. Galvin is the director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the study director and principal investigator on the SHIMMER study grant from the National Institute of Aging. Dr. Galvin added, 'As a physician, it's always rewarding when you are able to offer a medication to a patient that may make a meaningful impact on their health. To have touched the anonymous donor's life so meaningfully that they felt compelled to support an expanded access program for so many people is humbling and rewarding. This program is a unique opportunity, and one that my colleagues and I are excited to be involved in.' Initially, the EAP will be able to accommodate approximately 30 individuals, who will be treated with 100 mg of once-daily oral zervimesine for approximately one year. Additional patients may be treated as funding and drug supply allows. The EAP will be open to eligible SHIMMER participants who completed the Phase 2 study as well as additional patients with a diagnosis of mild-to-moderate DLB who meet the criteria for this program. Eight U.S. sites, all of which were active in the SHIMMER study, were selected to participate in the EAP. Banner Sun Health Research Institute is the first participating site to be activated. Dr. Shprecher, Banner Health's movement disorder director and a clinical associate professor at the University of Arizona College of Medicine – Phoenix, will serve as the site's EAP investigator. Dr. Shprecher also served as an investigator for the Phase 2 SHIMMER study. About the EAPThe EAP will operate under a new protocol and will be referred to as COG1202. As an investigational medicine, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. If you are a patient or caregiver wishing to know more about this EAP for DLB, we encourage you to discuss this Program with your treating physician. If you are a treating physician and are seeking information about the zervimesine EAP or would like to request access for a patient, please contact EAP@ More information is available on under study identifier NCT06961760. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'seek,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'forecast,' 'potential' or 'continue' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Global Market; and the risks and uncertainties described more fully in the 'Risk Factors' section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information: Cognition Therapeutics, Inc. info@ Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@ Mike Moyer (investors) LifeSci Advisors mmoyer@ This press release was published by a CLEAR® Verified in to access your portfolio
