Latest news with #LEQEMBI
Hamilton Spectator
6 days ago
- Health
- Hamilton Spectator
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. 'At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.' Key Scientific Sessions and Presentations: Educational Program on Tau in Alzheimer's Disease At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer's disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on , building on the resources already available. For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth. About BIIB080 BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis. About LEQEMBI ® (lecanemab) LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at . Follow us on social media - Facebook , LinkedIn , X , YouTube . Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Yahoo
28-05-2025
- Business
- Yahoo
Biogen Inc. (BIIB) Taps RNAi Therapy in City Therapeutics Deal
Biogen Inc. (NASDAQ:BIIB)'s recent partnership with City Therapeutics, Inc. to develop RNAi therapies for central nervous system diseases has fueled a 6% rise in its share price over the past month, reflecting renewed investor optimism. This move comes amid a broader rally in the tech sector driven by favorable policy shifts and positive market sentiment, as major indices have also trended upward. A scientist studying a petri dish with magnifying glass in a laboratory setting. The collaboration underscores Biogen Inc. (NASDAQ:BIIB)'s strategic pivot toward innovative treatments, expanding its pipeline beyond established Alzheimer's therapies like LEQEMBI. Analysts suggest this could strengthen BIIB's long-term growth prospects and help offset challenges such as declining multiple sclerosis revenues and mounting competition from generics and biosimilars. Despite the recent uptick, Biogen Inc. (NASDAQ:BIIB)'s three-year total shareholder return remains down 37.09%, significantly underperforming the broader US biotech industry, which gained 12.9% over the past year. The company's current share price still trades at a 36.67% discount to the analyst consensus target of $171.95, highlighting persistent investor caution regarding future earnings and revenue growth. While the RNAi collaboration may gradually shift market perceptions, BIIB faces ongoing pressure to deliver on its innovation-driven strategy and regain industry momentum. While we acknowledge the potential of BIIB to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BIIB and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Health
- Yahoo
Leqembi Market Report 2025-2034 - Leqembi Therapies Gain Ground Through Innovation and Strategic Alliances
Leqembi market analysis highlights key dynamics, including growth potential driven by increased Alzheimer's prevalence, advancements in treatments, and innovations in IV dosing. Key player Eisai Co. Ltd. focuses on early-stage Alzheimer's therapies. North America leads, with Asia-Pacific set for rapid growth. Dublin, May 13, 2025 (GLOBE NEWSWIRE) -- The "Leqembi Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts" has been added to offering. The Leqembi market report provides an extensive analysis of key market characteristics, including size, growth potential, and segmentation. Offering a detailed regional and national breakdown, the report highlights historical data and growth projections. It also explores the competitive landscape, market share insights, emerging trends, and strategic developments influencing the market. The historic period witnessed growth due to an increasing elderly population, enhanced funding for neurodegenerative research, improved reimbursement, ongoing clinical trials, and rising healthcare expenditure. The forecast period anticipates growth from greater R&D investments, increased awareness of early Alzheimer's diagnosis, and a heightened demand for treatments. There is also a stronger focus on addressing amyloid plaques, advancements in neuroscience, digital health technologies rise, improvement in Alzheimer's treatments, personalized medicine shift, and disease-modifying therapies development. Alzheimer's disease prevalence is a primary driver of the Leqembi market. This degenerative brain disorder gradually impacts memory and cognition, influenced by genetic, lifestyle, and environmental factors. Leqembi reduces beta-amyloid plaques, slowing cognitive decline in early Alzheimer's stages by preserving memory and cognitive functions. For instance, in 2024, the European Brain Council reported approximately 7 million people in Europe live with Alzheimer's, projecting an increase to 14 million by 2030 due to the aging population, illustrating its global public health impact. Innovation in IV maintenance dosing formulations for Alzheimer's therapy fuels the Leqembi market. This method ensures sustained therapeutic levels via direct bloodstream medication delivery. In June 2024, Eisai Co., Ltd., and Biogen Inc. announced FDA acceptance of a supplemental biologics license application for LEQEMBI's monthly IV maintenance regimen. LEQEMBI targets toxic amyloid proteins, offering potential treatment efficacy extension, reduced neuronal damage, and improved long-term patient outcomes. In November 2024, Biogen Inc. and Eisai Co., Ltd. collaborated to develop Alzheimer's treatments, focusing on Leqembi for early-stage patients. Eisai Co. Ltd. manufactures Leqembi, a key market player. Regionally, North America was the largest in the Leqembi market for 2024, while Asia-Pacific is projected as the fastest-growing region. The report covers regions including Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa, and countries such as the USA, Canada, UK, France, Germany, China, Japan, and others. Leqembi, a prescription medication for Alzheimer's, targets the neurodegenerative disorder by reducing amyloid-beta plaques. Its formulations include injectable forms such as IV injections for rapid absorption and dosing accuracy. Suitable for adult, geriatric, and early-stage Alzheimer's patients, Leqembi is distributed through various channels and utilized by hospitals, clinics, and home health providers. The market report provides comprehensive statistics, global size, regional shares, competitors' market share, detailed segments, and trends, offering a thorough perspective on current and future industry scenarios. The Leqembi market includes sales of oral tablets, injectable forms, and transdermal patches. Market value is derived from goods sold by manufacturers or creators, including related services, with revenues generated in specific geographies, excluding resales along the supply chain. Key Topics Covered: 1. Executive Summary 2. Leqembi Market Characteristics 3. Leqembi Market Biologic Drug Characteristics 3.1. Molecule Type 3.2. Route of Administration (ROA) 3.3. Mechanism of Action (MOA) 3.4. Safety and Efficacy 4. Leqembi Market Trends and Strategies 5. Leqembi Market -Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market 6. Global Leqembi Growth Analysis and Strategic Analysis Framework 6.1. Global Leqembi PESTEL Analysis 6.2. Analysis of End Use Industries 6.3. Global Leqembi Market Growth Rate Analysis 6.4. Global Leqembi Historic Market Size and Growth, 2019-2024, Value ($ Million) 6.5. Global Leqembi Forecast Market Size and Growth, 2024-2029, 2034F, Value ($ Million) 6.6. Global Leqembi Total Addressable Market (TAM) 7. Global Leqembi Pricing Analysis & Forecasts 8. Leqembi Market Segmentation 8.1. Global Leqembi Market, Segmentation by Formulation 8.2. Global Leqembi Market, Segmentation by Indication 8.3. Global Leqembi Market, Segmentation by Patient Demographics 8.4. Global Leqembi Market, Segmentation by Distribution Channel 8.5. Global Leqembi Market, Segmentation by End-User 9. Global Leqembi Epidemiology of Clinical Indications 9.1. Drug Side Effects 9.2. Incidence and Prevalence of Clinical Indications 10. Leqembi Market Regional and Country Analysis 10.1. Global Leqembi Market, Split by Region 10.2. Global Leqembi Market, Split by Country For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Yahoo
07-05-2025
- Business
- Yahoo
Biogen (NasdaqGS:BIIB) Selects Multiple Co-Lead Underwriters for US$1 Billion Fixed-Income Offering
Biogen appointed multiple co-lead underwriters for two fixed-income offerings totaling over $1 billion, showcasing its efforts to bolster financial offerings. This move, coupled with Biogen's recent earnings announcement, which reported a decline in net income and sales but an increase in revenue, did not align with the generally stable market performance over the same period. While these developments reflect Biogen's current financial strategies and performance, they could have added pressure to its 3% price decline last week amidst a mixed equities market and investor focus on broader economic factors such as the Fed's rate decisions. You should learn about the 2 possible red flags we've spotted with Biogen. NasdaqGS:BIIB Revenue & Expenses Breakdown as at May 2025 Uncover 16 companies that survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. The appointment of underwriters for Biogen's fixed-income offerings could potentially strengthen its liquidity position amidst recent financial challenges. As the company navigates a decline in net income and sales, this move might ease pressure on its finances and assist in financing new product initiatives, particularly the promising therapies in Alzheimer's and ALS. However, these financing strategies have not staved off a recent share price decline of 3%, suggesting that investors remain cautious amid mixed market signals and broader economic variables like the Federal Reserve's rate decisions. Over the past three years, Biogen's total shareholder return, including share price and dividends, was 40.09% lower, highlighting a significant underperformance. Meanwhile, in the past year, Biogen's performance lagged behind the broader US market, which saw a return of 7.2%, and also fell short of the US Biotechs industry that recorded a return of 14.1%. This gap underscores the ongoing challenges Biogen faces in maintaining investor confidence and aligning its financial strategies with market trends. The recent news about its fixed-income offerings could positively impact the company's revenue and earnings forecasts, particularly as Biogen continues to focus on innovative therapies. Although analysts forecast a 0.9% annual decline in revenue over the next three years, advancements like LEQEMBI might alter this outlook if adopted widely. Regarding the price target, Biogen's current share price of US$120.17 is notably below the consensus analyst target of US$173.52, indicating considerable room for potential value adjustment as the company addresses its operational and strategic objectives. The valuation report we've compiled suggests that Biogen's current price could be quite moderate.
Yahoo
27-01-2025
- Health
- Yahoo
Eisai and Biogen's LEQEMBI sBLA set for Alzheimer's maintenance dosing
The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's LEQEMBI (lecanemab-irmb) for maintenance dosing once every four weeks for the early stages of Alzheimer's disease. The approval is particularly for individuals with mild cognitive impairment or who are at the mild dementia stage. Individuals may transition to a 10 mg/kg once every four weeks regimen after an 18-month initiation phase or continue with the bi-weekly regimen. The approval is supported by data from the Phase II study (Study 201) and its long-term extension (LTE), along with the Clarity Alzheimer's study and its LTE. Modelling simulations suggest that the new dosing schedule will maintain the therapy's clinical and biomarker benefits. Operated by continuously clearing protofibrils and rapidly clearing plaque, LEQEMBI claims to address the progressive nature of Alzheimer's. The therapy is already approved in Japan, China, the US, South Korea and the UK. The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the therapy for approval in November 2024. Eisai has filed for approval in 17 nations and regions. It leads the development and regulatory submissions for the therapy globally, with both companies jointly promoting and commercialising the product. The US regulator has set a Prescription Drug User Fee Act (PDUFA) action date of 31 August 2025 for Eisai's sBLA for the LEQEMBI subcutaneous autoinjector. Eisai holds the final decision-making authority. Lecanemab, developed through a strategic research alliance between Eisai and BioArctic, is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting aggregated soluble and insoluble forms of amyloid-beta (Aβ). "Eisai and Biogen's LEQEMBI sBLA set for Alzheimer's maintenance dosing" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
