Latest news with #LEQEMBI
Perth Now
5 days ago
- Health
- Perth Now
Young mum, 29, shares heartbreaking wish after her shock Alzheimer's diagnosis
Single mother Erin Kelly received a life-changing diagnosis in June. But the 29-year-old from Eagleby, Queensland, has known since she was a teenager that one day Alzheimer's disease, which is the most common cause of dementia, could come for her. 'My mum died of Alzheimer's when she was 50,' Kelly told 'The disease took my grandfather at 45, and my aunt when she was the same age. 'I just didn't think it would come for me so soon.' In May 2024, tests confirmed Kelly had inherited a rare genetic mutation called PSEN1 from her mother, Robyne. Carriers of the genetic mutation are at high risk of developing Alzheimer's disease — a progressive brain condition that causes memory loss and cognitive decline — often before the age of 65. Erin Kelly and her eight-year-old daughter, Evie. Credit: Supplied Erin Kelly as a young girl with her mother, who was also diagnosed with Alzheimer's disease. Credit: Supplied In June, scans revealed the first signs of damage to Kelly's neurons, which are cells in the brain that carry messages. When the mum-of-one was given the official diagnosis of early onset Alzheimer's, Kelly says, 'I was in a bit of denial at first'. While dementia can happen to anybody, it is most common after the age of 65. A diagnosis of any kind of dementia when you're younger than 65 is called early onset dementia, or younger onset dementia, and is extremely rare. While Kelly's doctors can't say how quickly the disease will progress, it will soon begin to affect her memory, thinking and behaviour, with her condition expected to deteriorate over time. 'I've started to notice small changes already,' Kelly said. 'Forgetting words and mixing words together. 'I'll be thinking of something, and I'll just mush the words together. 'It's things I didn't do previously.' There is no cure, but Kelly is determined to spend the time she has left making lasting memories for her daughter, Evie, 8. 'We're not exactly sure how or what to tell her yet. She's still so young,' Kelly explained. 'She will get some information, but we want to protect her for as long as we can. 'The goal is to see her finish school, get married. 'I want to make sure she's an adult before I die.' Erin's stepsister Jessica Simpson has set up a Go Fund Me page for Kelly to raise money for a treatment called lecanemab (LEQEMBI). Erin Kelly and her stepsister Jessica Simpson, with their daughters, Evie, 8, and Dallas, 6. Credit: Supplied Erin Kelly is determined to spend the time she has left making lasting memories for her eight-year-old daughter Evie. Credit: Supplied The treatment could help slow down how quickly the disease progresses. In October 2024, the TGA made the decision not to register the medication in Australia, meaning 18 months of treatment could cost Kelly up to $90,000. 'Even with a confirmed diagnosis, Erin has been told she's too young to qualify for clinical trials in Australia,' Simpson explained. 'This treatment could give her more time to keep working, keep functioning and most importantly, keep being Evie's mum for as long as she can.' According to Dementia Australia, dementia is the term used to describe the symptoms of a large group of illnesses which cause a progressive decline in a person's functioning. It is a broad term used to describe a loss of memory, intellect, rationality, social skills and physical functioning. There are many types of dementia, including Alzheimer's disease, vascular disease, frontotemporal dementia and Lewy body disease. Today, there are roughly 433,000 Australians living with dementia and there are an estimated 29,000 people living with younger onset dementia, which can include people in their 30s, 40s and 50s. 'Most people don't associate Alzheimer's with someone so young,' Jessica said. 'Someone still packing school lunches, doing bedtime stories and showing up every day for their child. 'But this is Erin's reality. And sadly, it's progressing fast.'
7NEWS
6 days ago
- Health
- 7NEWS
Young mum, 29, diagnosed with Alzheimer's disease shares heartbreaking wish to see her daughter finish school
Single mother Erin Kelly received a life-changing diagnosis in June. But the 29-year-old from Eagleby, Queensland, has known since she was a teenager that one day Alzheimer's disease, which is the most common cause of dementia, could come for her. 'My mum died of Alzheimer's when she was 50,' Kelly told 'The disease took my grandfather at 45, and my aunt when she was the same age. 'I just didn't think it would come for me so soon.' In May 2024, tests confirmed Kelly had inherited a rare genetic mutation called PSEN1 from her mother, Robyne. Carriers of the genetic mutation are at high risk of developing Alzheimer's disease — a progressive brain condition that causes memory loss and cognitive decline — often before the age of 65. In June, scans revealed the first signs of damage to Kelly's neurons, which are cells in the brain that carry messages. When the mum-of-one was given the official diagnosis of early onset Alzheimer's, Kelly says, 'I was in a bit of denial at first'. While dementia can happen to anybody, it is most common after the age of 65. A diagnosis of any kind of dementia when you're younger than 65 is called early onset dementia, or younger onset dementia, and is extremely rare. While Kelly's doctors can't say how quickly the disease will progress, it will soon begin to affect her memory, thinking and behaviour, with her condition expected to deteriorate over time. 'I've started to notice small changes already,' Kelly said. 'Forgetting words and mixing words together. 'I'll be thinking of something, and I'll just mush the words together. 'It's things I didn't do previously.' There is no cure, but Kelly is determined to spend the time she has left making lasting memories for her daughter, Evie, 8. 'We're not exactly sure how or what to tell her yet. She's still so young,' Kelly explained. 'She will get some information, but we want to protect her for as long as we can. 'The goal is to see her finish school, get married. 'I want to make sure she's an adult before I die.' Erin's stepsister Jessica Simpson has set up a Go Fund Me page for Kelly to raise money for a treatment called lecanemab (LEQEMBI). The treatment could help slow down how quickly the disease progresses. In October 2024, the TGA made the decision not to register the medication in Australia, meaning 18 months of treatment could cost Kelly up to $90,000. 'Even with a confirmed diagnosis, Erin has been told she's too young to qualify for clinical trials in Australia,' Simpson explained. 'This treatment could give her more time to keep working, keep functioning and most importantly, keep being Evie's mum for as long as she can.' According to Dementia Australia, dementia is the term used to describe the symptoms of a large group of illnesses which cause a progressive decline in a person's functioning. It is a broad term used to describe a loss of memory, intellect, rationality, social skills and physical functioning. There are many types of dementia, including Alzheimer's disease, vascular disease, frontotemporal dementia and Lewy body disease. Today, there are roughly 433,000 Australians living with dementia and there are an estimated 29,000 people living with younger onset dementia, which can include people in their 30s, 40s and 50s. 'Most people don't associate Alzheimer's with someone so young,' Jessica said. 'Someone still packing school lunches, doing bedtime stories and showing up every day for their child. 'But this is Erin's reality. And sadly, it's progressing fast.'
Yahoo
30-07-2025
- Health
- Yahoo
New Data Presented at AAIC Demonstrates Investigational LEQEMBI® (lecanemab-irmb) 360 mg Subcutaneous Maintenance Dosing Could Offer a New Option for Ongoing Treatment of Early Alzheimer's Disease
Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer's disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation TOKYO and CAMBRIDGE, Mass., July 30, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, and virtually. Only lecanemab fights AD in two ways— targeting both protofibrils and plaque, which can impact tau accumulation downstream. Importance of Ongoing Treatment and SC Development Program Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped1, Eisai is investigating a new lecanemab SC maintenance treatment option following 18 months of IV therapy so patients can continue to fight this progressive, relentless disease. Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. Eisai has developed a SC-AI for maintenance therapy at a dose of 360 mg weekly and a 500 mg SC-AI is being developed for initiation dosing. Similar Impact on Clinical Outcomes and Biomarkers with IV and SC Dosing The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option. Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing. Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months. Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10 mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E. Safety MattersThe safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <1% systemic injection/infusion reactions. Across all SC doses, the rate of systemic injection/infusion reactions is 1% compared to 26% with IV. The 360 mg SC maintenance dose was initiated after 18 months of IV treatment, beyond the high-risk period for ARIA. There were 0 cases of ARIA-E observed out of 49 treated with 360 mg SC weekly maintenance for a mean of 6 months. Study Participants Successfully Administered SC-AI and Found it Easy to UseTo optimize the safe and effective use of SC autoinjector (SC-AI), additional studies were conducted, including a human factors (HF) study and a tolerability assessment of the device. The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall, 95% (104/110) of participants successfully administered the maintenance dose. The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over 95% of participants reported that the SC-AI is easy to administer. They were highly satisfied with it and had no concerns about administration, even at home. Furthermore, all patients responded that they welcomed the introduction of SC-AI. These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events. From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time, and to continue treatment without having to worry about visiting an infusion center. From the perspective of HCPs, they reported that the device has the potential to provide a new option for patients who are benefiting from lecanemab to continue the treatment. The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD. This release is based on the content of the presentations given at AAIC, "Featured Research Session #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease," held at 9:00 AM on Wednesday, July 30, and also includes some content from the Developing Topics session held at 8:00 AM on Sunday, July 27, entitled "Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients." Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. * Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. 2 MEDIA CONTACTSEisai Co., Ltd. Public Relations Department TEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department +44 (0) 797 487 9419 Emea-comms@ Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 Libby_Holman@ Biogen Inc. Madeleine Shin +1-781-464-3260 INVESTOR CONTACTSEisai Co., Ltd. Investor Relations Department TEL: +81 (0) 3-3817-5122 Biogen Inc. Tim Power + 1-781-464-2442 IR@ Notes to Editors 1. About lecanemab (generic name, brand name: LEQEMBI®)Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells.2 It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction. Lecanemab has been approved in 46 countries and is under regulatory review in 11 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S. After an 18 months initiation phase with once every two weeks of dosing, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks or continuing 10 mg/kg once every two weeks may be considered. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. 2. About the Collaboration between Eisai and Biogen for ADEisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. 3. About the Collaboration between Eisai and BioArctic for ADSince 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. 4. About Eisai Co., Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners. For more information about Eisai, please visit (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit and Eisai EMEA LinkedIn. 5. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's 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. The company routinely posts information that may be important to investors on its website at Follow Biogen on social media – Facebook, LinkedIn, X, YouTube. Biogen Safe HarborThis news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; 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; the successful execution of our strategic and growth initiatives, including acquisitions; 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; 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. References Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. View original content to download multimedia: SOURCE Eisai Inc.
Hamilton Spectator
22-07-2025
- 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
