TOKYO and CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was presented at the 18th Clinical Trials on ...

Alpha Cognition (NasdaqCM:ACOG) Fireside Chat December 02, 2025 12:00 PM ET Company ParticipantsBoris Peaker - Head of Research and Managing DirectorMichael McFadden - CEOOperatorAll right, perfect. Maybe I'll just kick this off, in the sake of time.Boris PeakerSure.OperatorAppreciate everyone—appreciate everyone joining, for this fireside chat with Alpha Cognition. We have Michael McFadden, the CEO of Alpha Cognition, ACOG, on the line here today, along with Boris Peaker, who is our Head of Research and Ma ...

Core Viewpoint - Longeveron Inc. is presenting promising results from the CLEAR MIND study, indicating that laromestrocel treatment reduces neuroinflammation and improves clinical outcomes in patients with mild Alzheimer's disease [1][2][8]. Group 1: Study Presentation and Findings - The CLEAR MIND study results are being showcased at the 18th Clinical Trials on Alzheimer's Disease Conference, highlighting the impact of laromestrocel on neuroinflammation in Alzheimer's patients [1]. - Laromestrocel, a stem cell therapy, has shown potential in addressing the underlying pathology of Alzheimer's disease, with previous trials indicating improvements in cognitive function and brain volume [2][8]. - The treatment demonstrated a durable reduction in free water fraction, a measure of neuroinflammation, across multiple brain regions, including the hippocampus and temporal cortex [5][6]. Group 2: Mechanism of Action and Clinical Implications - Laromestrocel targets neuroinflammation and microvascular dysfunction, potentially stimulating tissue regeneration, which is crucial for treating Alzheimer's disease [4][10]. - The study found that the reduction in neuroinflammation correlated with the preservation of hippocampal volume and positive clinical outcomes, suggesting a sustained anti-inflammatory effect [7][8]. - The findings support the continued clinical development of laromestrocel for mild Alzheimer's disease, reinforcing its therapeutic potential [8]. Group 3: Company Overview and Regulatory Status - Longeveron is a clinical-stage biotechnology company focused on developing regenerative medicines, with laromestrocel as its lead investigational product [10]. - The company has received multiple FDA designations for laromestrocel, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for its Alzheimer's program [2][10]. - Longeveron is also pursuing other indications, including hypoplastic left heart syndrome and pediatric dilated cardiomyopathy, showcasing its broad application potential [10].

Core Insights - Merck is set to present first-in-human data for Alzheimer's disease candidates MK-2214 and MK-1167 at CTAD 2025, highlighting its commitment to addressing this significant medical challenge [1][3] - MK-2214 has received Fast Track Designation from the U.S. FDA, aimed at expediting its development for Alzheimer's treatment [1][3] Group 1: Candidate Details - MK-2214 is a novel antibody targeting phosphorylated serine 413 (pS413) tau, with data from three Phase 1 studies to be presented [6] - MK-1167 is an oral positive allosteric modulator of the alpha-7 nicotinic acetylcholine receptor, with data from a Phase 1 first-in-human study also to be shared [6] Group 2: Study Outcomes - The Phase 1 studies for MK-2214 assessed safety, tolerability, and pharmacokinetics in healthy volunteers and individuals with mild cognitive impairment and mild-to-moderate Alzheimer's disease [6] - The Phase 1 study for MK-1167 evaluated its effect on glutamate metabolism in healthy adult male volunteers, informing dose selection for an ongoing Phase 2 trial [6] Group 3: Alzheimer's Disease Context - Alzheimer's disease affects approximately seven million people in the U.S., projected to rise to 14 million by 2060, emphasizing the urgent need for effective treatments [8] - Recent advancements in human genetics and technology are enhancing understanding of Alzheimer's pathology, driving innovative research [8]

Core Insights - Anavex Life Sciences Corp. is focused on developing treatments for central nervous system diseases, particularly Alzheimer's disease with its drug blarcamesine [1] - The company is gaining attention in the biopharmaceutical sector, competing with others in the Alzheimer's treatment market [1] Stock Performance - H.C. Wainwright reiterated a "Buy" rating for AVXL, with the stock trading at $3.86, reflecting confidence in the company's potential despite a "hold" action [2] - The stock has increased by 11.56%, rising by $0.40, indicating positive market sentiment [2] - AVXL's stock has fluctuated between $3.46 and $3.90 during the day, with a market capitalization of approximately $344.88 million [5] - Over the past year, the stock reached a high of $14.44 and a low of $2.86, showcasing its volatility [5][6] Clinical Developments - Anavex is set to present significant findings on blarcamesine at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, focusing on Phase IIb/III trial results [3] - The trial results indicate improvements in clinical outcomes and quality of life for early Alzheimer's patients, aligning with the company's innovative treatment focus [3] - The presentations will be led by Dr. Marwan Noel Sabbagh and Dr. Audrey Gabelle, emphasizing blarcamesine's potential in treating Alzheimer's [4] - Blarcamesine's mechanism of action involves restoring autophagy, crucial for cellular health, which may be key in addressing Alzheimer's [4]

Core Viewpoint - The announcement highlights Eisai and Biogen's application for lecanemab's subcutaneous formulation in Japan, which, if approved, would be the first at-home injection treatment for Alzheimer's disease in the country [1][2]. Group 1: Product Development and Approval - Eisai has filed a new drug application for lecanemab seeking approval for a subcutaneous autoinjector (SC-AI) in Japan [1]. - The application is based on Phase 3 Clarity AD open-label extension data, confirming that the once-weekly SC-AI 500mg administration is equivalent to the intravenous (IV) administration every two weeks [2]. - If approved, the SC-AI would allow patients to receive treatment at home, reducing the need for hospital visits for IV administration [3]. Group 2: Clinical Efficacy and Safety - Lecanemab targets both protofibrils and amyloid plaques, addressing the underlying neurotoxic processes in Alzheimer's disease [4]. - The safety profile of subcutaneous administration is similar to IV administration, with less than 2% incidence of systemic injection-related reactions [2]. Group 3: Market Presence and Regulatory Status - Lecanemab is currently approved in 51 countries and regions and is under regulatory review in 9 countries [4][9]. - The drug received manufacturing and marketing approval in Japan in September 2023 for treating mild cognitive impairment and mild dementia due to Alzheimer's disease [9]. Group 4: Collaboration and Strategic Alliances - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [5][11]. - The collaboration between Eisai and BioArctic for the development of lecanemab has been ongoing since 2005, with Eisai obtaining global rights for its commercialization [12].

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. have filed a new drug application for a subcutaneous formulation of LEQEMBI (lecanemab) in Japan, aiming to provide an alternative administration route for Alzheimer's disease treatment [1][2][3] Group 1: Drug Application and Administration - The application is based on Phase 3 Clarity AD open-label extension data, confirming that a once-weekly subcutaneous administration of 500 mg is equivalent to the current intravenous administration every two weeks [2] - If approved, the subcutaneous autoinjector (SC-AI) would allow patients to administer LEQEMBI at home, potentially reducing healthcare resource utilization associated with intravenous dosing [3] Group 2: Clinical Efficacy and Safety - LEQEMBI targets both protofibrils and amyloid plaques, addressing the neurotoxic processes in Alzheimer's disease, and has shown a safety profile similar to intravenous administration with less than 2% incidence of systemic reactions [2][4] - The drug is currently approved in 51 countries and regions and is under regulatory review in 9 countries, indicating a broad acceptance and ongoing evaluation of its efficacy [4][9] Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [5][11] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development and commercialization of Alzheimer's disease treatments [12]

Core Insights - Anavex Life Sciences Corp. will present one oral late breaking communication and two poster presentations on blarcamesine at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference in San Diego from December 1-4, 2025 [1][6]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, and other CNS disorders [1][9]. - The lead drug candidate, ANAVEX2-73 (blarcamesine), has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease and has shown potential in treating other CNS disorders [9]. Presentation Details - The presentations will include: 1. Oral Blarcamesine Phase IIb/III Trial confirming significant clinical and quality of life improvements for early Alzheimer's disease patients [5]. 2. Comparison of Oral Blarcamesine to normal cognitive aging, demonstrating alignment with prodromal cognitive aging trajectories [5]. 3. Discussion on advancing Alzheimer's disease care with the convenience of oral blarcamesine [5]. Mechanism of Action - Blarcamesine works by restoring autophagy, which is crucial for cellular homeostasis and may help treat Alzheimer's by activating the brain's recycling process [3]. - The drug has shown clinically meaningful effects in slowing cognitive decline in early Alzheimer's disease patients with an adequate safety profile [3]. Conference Significance - The CTAD Conference is a key event in Alzheimer's disease clinical research, fostering collaboration and dialogue among researchers [4][6]. - The conference will feature discussions on various advancements in Alzheimer's research, including disease-modifying agents and gene therapy [7]. Research Quality - The scientific program of CTAD is supported by a rigorous peer-review abstract selection process, ensuring high-quality research presentations [8].

Core Insights - Novo Nordisk (NVO) reported disappointing results from late-stage studies of Rybelsus for early-stage symptomatic Alzheimer's disease, leading to a 5.6% drop in shares [1] Group 1: Study Results - The phase III evoke and evoke+ studies involved 3,808 adults with mild cognitive impairment or mild dementia due to Alzheimer's, randomized to receive either Rybelsus or placebo for 156 weeks [2] - Rybelsus did not show clinical superiority over placebo in slowing Alzheimer's progression, despite improving AD-related biomarkers [4][7] - The company will discontinue the 52-week extension phase of the studies and plans to present top-line data in December, with full results expected in 2026 [9] Group 2: Market Performance - Year-to-date, Novo Nordisk shares have decreased by 47.7%, contrasting with a 16% growth in the industry [6] Group 3: Product Information - Rybelsus is currently approved for type II diabetes management and has expanded indications for cardiovascular risk reduction [3] - Novo Nordisk is seeking approval for a 25 mg oral formulation of semaglutide for obesity and cardiovascular disease, which could be the first oral GLP-1 therapy for chronic weight management [12] - The company is also pursuing label expansions for Ozempic to treat peripheral artery disease in the U.S. and EU [12][13]

Financial Data and Key Metrics Changes - The company's cash position as of September 30 was $102.6 million, with no debt [15] - Cash utilized in operating activities during the quarter was $8.6 million, with a current cash balance of over $120 million, indicating a cash runway of more than three years at the current utilization rate [16] - Research and development expenses for the quarter were $7.3 million, down from $11.6 million in the same quarter last year, while general and administrative expenses increased to $3.5 million from $2.7 million [16][17] - The net loss for the quarter was reported at $9.8 million, equating to $0.11 per share [17] Business Line Data and Key Metrics Changes - The company is focused on advancing its precision medicine compounds, particularly Blarcamesine and ANAVEX3-71, with ongoing clinical trials and regulatory actions [3][6] - Blarcamesine has shown significant clinical efficacy in slowing cognitive decline in early Alzheimer's disease patients, with a reported 50% reduction in decline in some cases [24][72] Market Data and Key Metrics Changes - The company is exploring regulatory opportunities beyond the European Union and the United States for Blarcamesine [25] - Initial contacts have been made with U.S. authorities regarding the Alzheimer's disease program, with updates expected [5][6] Company Strategy and Development Direction - The company aims to expand collaborative initiatives and strategic partnerships while progressing clinical trials and regulatory actions [3][4] - There is a focus on addressing the unmet medical need in Alzheimer's disease, especially in light of recent setbacks in the market [23][35] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the complexity of Alzheimer's disease and the challenges faced in developing effective treatments, emphasizing the unique mechanism of action of Blarcamesine [23][24] - The company remains committed to working with regulatory bodies to advance its investigational therapies and is optimistic about the potential for Blarcamesine to address significant unmet needs [4][72] Other Important Information - The company has published several scientific papers highlighting the efficacy of Blarcamesine in preventing cognitive decline and its mechanisms of action [7][8] - The company is preparing for upcoming presentations at major conferences to further discuss its findings and potential partnerships [38] Q&A Session Summary Question: What is the likely commercial impact of the failure of semaglutide on the outlook for Blarcamesine in Alzheimer's disease? - Management noted that the unmet medical need is highlighted by recent setbacks in the market, emphasizing the complexity of Alzheimer's disease and the unique benefits of Blarcamesine [23][24] Question: When is the next formal discussion of Blarcamesine scheduled to take place with the FDA? - Management indicated that updates will follow initial discussions with U.S. regulators as they become available [24] Question: What initiatives does Anavex plan near-term to pursue Blarcamesine approval in regions beyond the European Union and the United States? - The company is exploring other regulatory geographies and moving forward to address open questions [25] Question: Can you elaborate on the additional information needed by the CHMP? - Management stated that they aim to demonstrate that the benefits of Blarcamesine outweigh the risks, including providing objective biomarker data [27][28] Question: Can the ABCLEAR data be included for consideration on re-examination? - Management expressed the intention to highlight the significant clinical improvements observed in the ABCLEAR studies during the re-examination process [30][32] Question: If approval ultimately came from the EMA, how long would a conditional trial take? - Management refrained from speculating but emphasized the significant unmet need for effective treatments [34] Question: How is the company exploring options for large pharma sales organizations if approval is granted? - Management highlighted the focus on expanding corporate development partnership activities and presenting at key conferences [36][38] Question: Does Anavex have support from the community for its drug? - Management indicated that the community is aware of the drug, and they are committed to the process of gaining regulatory approval [67] Question: Will the company immediately refill for the EMA re-evaluation? - Management confirmed that they will request re-examination as soon as possible, with a hopeful timeline for updates [65]