This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsBiogen（IDPD）株式概要バイオジェン社は、米国、欧州、ドイツ、アジア、および国際的に治療薬の発見、開発、製造、販売を行っています。 詳細IDPD ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より56%で取引されている 収益は年間13.82%増加すると予測されています リスク分析財務結果に影響を与える大きな一時的項目 すべてのリスクチェックを見るIDPD Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€165.7033.9% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture014b2016201920222025202620282031Revenue US$11.2bEarnings US$1.5bAdvancedSet Fair ValueView all narrativesBiogen Inc. 競合他社GenusSymbol: LSE:GNSMarket cap: UK£1.4bHaleonSymbol: LSE:HLNMarket cap: UK£30.0bBioventixSymbol: AIM:BVXPMarket cap: UK£81.0mGSKSymbol: LSE:GSKMarket cap: UK£76.7b価格と性能株価の高値、安値、推移の概要Biogen過去の株価現在の株価US$165.7052週高値US$052週安値US$0ベータ0.191ヶ月の変化1.69%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化11.46%最新ニュースお知らせ • May 24Biogen Inc. and Denali Therapeutics Inc. Provide Update on Phase 2b LUMA Study Of BIIB122 In Early-Stage Parkinson’s DiseaseBiogen Inc. and Denali Therapeutics Inc. announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson’s disease. Results from the study show that BIIB122 did not slow the progression of Parkinson’s disease versus placebo, as measured by the primary endpoint of Time to Confirmed Worsening in the modified Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III combined score. Secondary endpoints also did not show a benefit with BIIB122. Exploratory biomarker endpoints demonstrated >90% kinase inhibition of peripheral LRRK2 (phosphoserine 935) and, in a cerebrospinal fluid (CSF) sub-study, up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10). Expected levels of BIIB122 in the blood and CSF were sustained across the study. BIIB122 was generally well tolerated with an acceptable safety profile. Based on these results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to independently conduct the Phase 2a BEACON study evaluating the small molecule inhibitor in carriers of a pathogenic LRRK2 variant. LUMA was a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of BIIB122 compared to placebo in 648 people with early-stage Parkinson’s disease between the ages of 30 and 80. Participants received BIIB122 or placebo for a minimum of 48 weeks and up to 144 weeks. The study included individuals with early-stage Parkinson’s disease with or without a pathogenic LRRK2 variant. The LUMA study was designed to evaluate the potential of LRRK2 inhibition to address the underlying biology of Parkinson’s disease. The global Phase 2a BEACON study is designed to assess safety, pharmacokinetics and biomarkers of lysosomal pathway engagement, which will inform the biomarker profile in LRRK2 pathogenic variant carriers and the impact of LRRK2 inhibition. Data from the BEACON study is anticipated in the first half of 2027. The BEACON study is being operationalized by Denali and funded under a Collaboration and Development Funding Agreement between Denali and a third party. Biogen and Denali will share detailed findings from the LUMA study at an upcoming scientific conference to contribute to the broader understanding of Parkinson’s disease and LRRK2 biology.お知らせ • May 16+ 1 more updateBiogen Announces Topline Results from Phase 2 Celia Study of DiranersenBiogen announced topline results from the Phase 2 CELIA study of diranersen, an investigational therapy designed to target tau in people with early Alzheimer's disease. The study did not meet its primary endpoint, Biogen reported reductions in tau and signals of slowed cognitive decline and plans to advance the drug into further trials. Diranersen is the first therapy of its kind to reach this stage, offering early proof of concept that reducing tau could have both biological and clinical effects. With two disease-modifying anti-amyloid therapies now available, tau presents an important opportunity for expanding Alzheimer's treatment options. These results come as the Alzheimer's pipeline continues to grow and evolve, with 75% of current trials now aimed at pathways beyond amyloid and tau, including inflammation, metabolic dysfunction, and oxidative stress. This broadening range of targets is critical to the future of Alzheimer's care, as the field moves toward combination approaches that can address multiple underlying causes of the disease in tandem. Topline data from the CELIA study will be presented at the upcoming Alzheimer's Association International Conference (AAIC), taking place July 12-16, 2026, in London.お知らせ • May 15Biogen Announces Topline Results from Phase 2 Celia Study of Diranersen (Biib080)Biogen announced compelling topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease. CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development. Robust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study. Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly at the lowest dose. The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study. CELIA is an 18-month Phase 2 randomized, placebo-controlled, dose-ranging study evaluating diranersen, a tau-targeting antisense oligonucleotide (ASO). Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly in participants receiving the lowest dose of diranersen, 60 mg administered every 24 weeks. Diranersen also demonstrated robust reductions in both cerebrospinal fluid (CSF) tau and tau pathology, as measured by positron emission tomography (PET), across all studied doses, with reductions maintained throughout the dosing period. CELIA did not meet its primary endpoint assessing dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. The safety and tolerability profile of diranersen across all studied doses was generally consistent with the Phase 1b study and the known profile of diranersen to date. The incidence of adverse events (AEs) was comparable across dose groups, with a higher incidence of serious adverse events (SAEs) observed at the highest dose studied. CELIA is a pioneering study evaluating diranersen, a first-in-class investigational ASO designed to reduce the production of tau protein at its source in early Alzheimer’s disease. While tau plays an important role in the normal function of brain cells, in Alzheimer’s disease abnormal tau can accumulate and form intracellular tangles that contribute to neurodegeneration and cognitive decline. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both extracellular and intracellular tau. Diranersen (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 associated with neurodegeneration and cognitive decline. Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of 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 diranersen. Diranersen was discovered by Ionis. CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy. The study evaluated three doses of diranersen administered intrathecally over a 76-week placebo-controlled treatment period: 60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks. The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer’s disease.お知らせ • May 11Eisai Co., Ltd. and Biogen Inc. Update on Fda Priority Review of Leqembi Iqlik (Lecanemab-Irmb) Subcutaneous Injection as A Starting Dose for Early Alzheimer's DiseaseEisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose. Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025. LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. 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 (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. 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. 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.最新情報をもっと見るRecent updatesお知らせ • May 24Biogen Inc. and Denali Therapeutics Inc. Provide Update on Phase 2b LUMA Study Of BIIB122 In Early-Stage Parkinson’s DiseaseBiogen Inc. and Denali Therapeutics Inc. announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson’s disease. Results from the study show that BIIB122 did not slow the progression of Parkinson’s disease versus placebo, as measured by the primary endpoint of Time to Confirmed Worsening in the modified Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III combined score. Secondary endpoints also did not show a benefit with BIIB122. Exploratory biomarker endpoints demonstrated >90% kinase inhibition of peripheral LRRK2 (phosphoserine 935) and, in a cerebrospinal fluid (CSF) sub-study, up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10). Expected levels of BIIB122 in the blood and CSF were sustained across the study. BIIB122 was generally well tolerated with an acceptable safety profile. Based on these results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to independently conduct the Phase 2a BEACON study evaluating the small molecule inhibitor in carriers of a pathogenic LRRK2 variant. LUMA was a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of BIIB122 compared to placebo in 648 people with early-stage Parkinson’s disease between the ages of 30 and 80. Participants received BIIB122 or placebo for a minimum of 48 weeks and up to 144 weeks. The study included individuals with early-stage Parkinson’s disease with or without a pathogenic LRRK2 variant. The LUMA study was designed to evaluate the potential of LRRK2 inhibition to address the underlying biology of Parkinson’s disease. The global Phase 2a BEACON study is designed to assess safety, pharmacokinetics and biomarkers of lysosomal pathway engagement, which will inform the biomarker profile in LRRK2 pathogenic variant carriers and the impact of LRRK2 inhibition. Data from the BEACON study is anticipated in the first half of 2027. The BEACON study is being operationalized by Denali and funded under a Collaboration and Development Funding Agreement between Denali and a third party. Biogen and Denali will share detailed findings from the LUMA study at an upcoming scientific conference to contribute to the broader understanding of Parkinson’s disease and LRRK2 biology.お知らせ • May 16+ 1 more updateBiogen Announces Topline Results from Phase 2 Celia Study of DiranersenBiogen announced topline results from the Phase 2 CELIA study of diranersen, an investigational therapy designed to target tau in people with early Alzheimer's disease. The study did not meet its primary endpoint, Biogen reported reductions in tau and signals of slowed cognitive decline and plans to advance the drug into further trials. Diranersen is the first therapy of its kind to reach this stage, offering early proof of concept that reducing tau could have both biological and clinical effects. With two disease-modifying anti-amyloid therapies now available, tau presents an important opportunity for expanding Alzheimer's treatment options. These results come as the Alzheimer's pipeline continues to grow and evolve, with 75% of current trials now aimed at pathways beyond amyloid and tau, including inflammation, metabolic dysfunction, and oxidative stress. This broadening range of targets is critical to the future of Alzheimer's care, as the field moves toward combination approaches that can address multiple underlying causes of the disease in tandem. Topline data from the CELIA study will be presented at the upcoming Alzheimer's Association International Conference (AAIC), taking place July 12-16, 2026, in London.お知らせ • May 15Biogen Announces Topline Results from Phase 2 Celia Study of Diranersen (Biib080)Biogen announced compelling topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease. CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development. Robust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study. Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly at the lowest dose. The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study. CELIA is an 18-month Phase 2 randomized, placebo-controlled, dose-ranging study evaluating diranersen, a tau-targeting antisense oligonucleotide (ASO). Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly in participants receiving the lowest dose of diranersen, 60 mg administered every 24 weeks. Diranersen also demonstrated robust reductions in both cerebrospinal fluid (CSF) tau and tau pathology, as measured by positron emission tomography (PET), across all studied doses, with reductions maintained throughout the dosing period. CELIA did not meet its primary endpoint assessing dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. The safety and tolerability profile of diranersen across all studied doses was generally consistent with the Phase 1b study and the known profile of diranersen to date. The incidence of adverse events (AEs) was comparable across dose groups, with a higher incidence of serious adverse events (SAEs) observed at the highest dose studied. CELIA is a pioneering study evaluating diranersen, a first-in-class investigational ASO designed to reduce the production of tau protein at its source in early Alzheimer’s disease. While tau plays an important role in the normal function of brain cells, in Alzheimer’s disease abnormal tau can accumulate and form intracellular tangles that contribute to neurodegeneration and cognitive decline. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both extracellular and intracellular tau. Diranersen (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 associated with neurodegeneration and cognitive decline. Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of 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 diranersen. Diranersen was discovered by Ionis. CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy. The study evaluated three doses of diranersen administered intrathecally over a 76-week placebo-controlled treatment period: 60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks. The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer’s disease.お知らせ • May 11Eisai Co., Ltd. and Biogen Inc. Update on Fda Priority Review of Leqembi Iqlik (Lecanemab-Irmb) Subcutaneous Injection as A Starting Dose for Early Alzheimer's DiseaseEisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose. Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025. LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. 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 (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. 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. 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.株主還元IDPDGB BiotechsGB 市場7D0%-2.2%-1.0%1Yn/a13.5%15.2%株主還元を見る業界別リターン: IDPDがUK Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: IDPD UK市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is IDPD's price volatile compared to industry and market?IDPD volatilityIDPD Average Weekly Movement4.4%Biotechs Industry Average Movement8.4%Market Average Movement5.6%10% most volatile stocks in GB Market11.7%10% least volatile stocks in GB Market3.1%安定した株価: IDPD 、 UK市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: 過去 1 年間のIDPDのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト19787,500Chris Viehbacherwww.biogen.comバイオジェン社は、米国、欧州、ドイツ、アジア、および国際的に治療薬の発見、開発、製造、販売を行っている。同社は、多発性硬化症（MS）治療薬としてTECFIDERA、VUMERITY、AVONEX、PLEGRIDY、TYSABRI、脊髄性筋萎縮症治療薬としてSPINRAZA、フリードライヒ失調症治療薬としてSKYCLARYS、筋萎縮性側索硬化症治療薬としてQALSODYを提供している；斑状乾癬治療薬FUMADERM、ENBRELに類似したエタネルセプトバイオシミラーBENEPALI、HUMIRAに類似したアダリムマブバイオシミラーIMRALDI、REMICADEに類似したインフリキシマブバイオシミラーFLIXABI。アルツハイマー病治療薬LEQEMBI、産後うつ病治療薬ZURZUVAE、非ホジキンリンパ腫、慢性リンパ性白血病（CLL）、関節リウマチ、2種類のANCA関連血管炎、尋常性天疱瘡治療薬RITUXANを提供している；非ホジキンリンパ腫およびCLLに対するリツキサンハイセラ、CLLおよび濾胞性リンパ腫に対するガザイバ、再発性MSおよび原発性進行性MSに対するオクレバス、再発または難治性の濾胞性リンパ腫に対するルンスミオ、再発または難治性のびまん性大細胞型B細胞リンパ腫に対するグロフィタマブ、およびその他の抗CD20療法。バイオジェン社は、メルツ・セラピューティクス社、アルケルメス・ファーマ・アイルランド社、デナリ・セラピューティクス社、UCB社、エーザイ株式会社、ジェネンテック社、ニューリミューン・サブワン社、イオニス・ファーマシューティカルズ社、サムスン・バイオエピス社、セージ・セラピューティクス社と提携およびライセンス契約を結んでいる、また、Dravet症候群の治療薬であるzorevunersenの開発および商品化に関するStoke Therapeutics社、経口大環状ペプチドの開発に関するDayra Therapeutics社、Vanqua Bio, Inc ALT-B4を利用した生物製剤の皮下（SC）製剤を開発するALTEOGEN Inc.などである。同社は1978年に設立され、マサチューセッツ州ケンブリッジに本社を置いている。もっと見るBiogen Inc. 基礎のまとめBiogen の収益と売上を時価総額と比較するとどうか。IDPD 基礎統計学時価総額€24.37b収益（TTM）€1.18b売上高(TTM)€8.53b20.3xPER（株価収益率2.8xP/SレシオIDPD は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計IDPD 損益計算書（TTM）収益US$9.94b売上原価US$2.11b売上総利益US$7.82bその他の費用US$6.45b収益US$1.37b直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）9.29グロス・マージン78.72%純利益率13.81%有利子負債／自己資本比率33.7%IDPD の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/02 16:12終値2026/05/22 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Biogen Inc. 22 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。58 アナリスト機関David ToungArgus Research CompanyBrian SkorneyBairdEmily FieldBarclays55 その他のアナリストを表示
お知らせ • May 24Biogen Inc. and Denali Therapeutics Inc. Provide Update on Phase 2b LUMA Study Of BIIB122 In Early-Stage Parkinson’s DiseaseBiogen Inc. and Denali Therapeutics Inc. announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson’s disease. Results from the study show that BIIB122 did not slow the progression of Parkinson’s disease versus placebo, as measured by the primary endpoint of Time to Confirmed Worsening in the modified Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III combined score. Secondary endpoints also did not show a benefit with BIIB122. Exploratory biomarker endpoints demonstrated >90% kinase inhibition of peripheral LRRK2 (phosphoserine 935) and, in a cerebrospinal fluid (CSF) sub-study, up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10). Expected levels of BIIB122 in the blood and CSF were sustained across the study. BIIB122 was generally well tolerated with an acceptable safety profile. Based on these results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to independently conduct the Phase 2a BEACON study evaluating the small molecule inhibitor in carriers of a pathogenic LRRK2 variant. LUMA was a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of BIIB122 compared to placebo in 648 people with early-stage Parkinson’s disease between the ages of 30 and 80. Participants received BIIB122 or placebo for a minimum of 48 weeks and up to 144 weeks. The study included individuals with early-stage Parkinson’s disease with or without a pathogenic LRRK2 variant. The LUMA study was designed to evaluate the potential of LRRK2 inhibition to address the underlying biology of Parkinson’s disease. The global Phase 2a BEACON study is designed to assess safety, pharmacokinetics and biomarkers of lysosomal pathway engagement, which will inform the biomarker profile in LRRK2 pathogenic variant carriers and the impact of LRRK2 inhibition. Data from the BEACON study is anticipated in the first half of 2027. The BEACON study is being operationalized by Denali and funded under a Collaboration and Development Funding Agreement between Denali and a third party. Biogen and Denali will share detailed findings from the LUMA study at an upcoming scientific conference to contribute to the broader understanding of Parkinson’s disease and LRRK2 biology.
お知らせ • May 16+ 1 more updateBiogen Announces Topline Results from Phase 2 Celia Study of DiranersenBiogen announced topline results from the Phase 2 CELIA study of diranersen, an investigational therapy designed to target tau in people with early Alzheimer's disease. The study did not meet its primary endpoint, Biogen reported reductions in tau and signals of slowed cognitive decline and plans to advance the drug into further trials. Diranersen is the first therapy of its kind to reach this stage, offering early proof of concept that reducing tau could have both biological and clinical effects. With two disease-modifying anti-amyloid therapies now available, tau presents an important opportunity for expanding Alzheimer's treatment options. These results come as the Alzheimer's pipeline continues to grow and evolve, with 75% of current trials now aimed at pathways beyond amyloid and tau, including inflammation, metabolic dysfunction, and oxidative stress. This broadening range of targets is critical to the future of Alzheimer's care, as the field moves toward combination approaches that can address multiple underlying causes of the disease in tandem. Topline data from the CELIA study will be presented at the upcoming Alzheimer's Association International Conference (AAIC), taking place July 12-16, 2026, in London.
お知らせ • May 15Biogen Announces Topline Results from Phase 2 Celia Study of Diranersen (Biib080)Biogen announced compelling topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease. CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development. Robust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study. Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly at the lowest dose. The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study. CELIA is an 18-month Phase 2 randomized, placebo-controlled, dose-ranging study evaluating diranersen, a tau-targeting antisense oligonucleotide (ASO). Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly in participants receiving the lowest dose of diranersen, 60 mg administered every 24 weeks. Diranersen also demonstrated robust reductions in both cerebrospinal fluid (CSF) tau and tau pathology, as measured by positron emission tomography (PET), across all studied doses, with reductions maintained throughout the dosing period. CELIA did not meet its primary endpoint assessing dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. The safety and tolerability profile of diranersen across all studied doses was generally consistent with the Phase 1b study and the known profile of diranersen to date. The incidence of adverse events (AEs) was comparable across dose groups, with a higher incidence of serious adverse events (SAEs) observed at the highest dose studied. CELIA is a pioneering study evaluating diranersen, a first-in-class investigational ASO designed to reduce the production of tau protein at its source in early Alzheimer’s disease. While tau plays an important role in the normal function of brain cells, in Alzheimer’s disease abnormal tau can accumulate and form intracellular tangles that contribute to neurodegeneration and cognitive decline. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both extracellular and intracellular tau. Diranersen (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 associated with neurodegeneration and cognitive decline. Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of 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 diranersen. Diranersen was discovered by Ionis. CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy. The study evaluated three doses of diranersen administered intrathecally over a 76-week placebo-controlled treatment period: 60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks. The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer’s disease.
お知らせ • May 11Eisai Co., Ltd. and Biogen Inc. Update on Fda Priority Review of Leqembi Iqlik (Lecanemab-Irmb) Subcutaneous Injection as A Starting Dose for Early Alzheimer's DiseaseEisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose. Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025. LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. 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 (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. 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. 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.
お知らせ • May 24Biogen Inc. and Denali Therapeutics Inc. Provide Update on Phase 2b LUMA Study Of BIIB122 In Early-Stage Parkinson’s DiseaseBiogen Inc. and Denali Therapeutics Inc. announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson’s disease. Results from the study show that BIIB122 did not slow the progression of Parkinson’s disease versus placebo, as measured by the primary endpoint of Time to Confirmed Worsening in the modified Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III combined score. Secondary endpoints also did not show a benefit with BIIB122. Exploratory biomarker endpoints demonstrated >90% kinase inhibition of peripheral LRRK2 (phosphoserine 935) and, in a cerebrospinal fluid (CSF) sub-study, up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10). Expected levels of BIIB122 in the blood and CSF were sustained across the study. BIIB122 was generally well tolerated with an acceptable safety profile. Based on these results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to independently conduct the Phase 2a BEACON study evaluating the small molecule inhibitor in carriers of a pathogenic LRRK2 variant. LUMA was a Phase 2b multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of BIIB122 compared to placebo in 648 people with early-stage Parkinson’s disease between the ages of 30 and 80. Participants received BIIB122 or placebo for a minimum of 48 weeks and up to 144 weeks. The study included individuals with early-stage Parkinson’s disease with or without a pathogenic LRRK2 variant. The LUMA study was designed to evaluate the potential of LRRK2 inhibition to address the underlying biology of Parkinson’s disease. The global Phase 2a BEACON study is designed to assess safety, pharmacokinetics and biomarkers of lysosomal pathway engagement, which will inform the biomarker profile in LRRK2 pathogenic variant carriers and the impact of LRRK2 inhibition. Data from the BEACON study is anticipated in the first half of 2027. The BEACON study is being operationalized by Denali and funded under a Collaboration and Development Funding Agreement between Denali and a third party. Biogen and Denali will share detailed findings from the LUMA study at an upcoming scientific conference to contribute to the broader understanding of Parkinson’s disease and LRRK2 biology.
お知らせ • May 16+ 1 more updateBiogen Announces Topline Results from Phase 2 Celia Study of DiranersenBiogen announced topline results from the Phase 2 CELIA study of diranersen, an investigational therapy designed to target tau in people with early Alzheimer's disease. The study did not meet its primary endpoint, Biogen reported reductions in tau and signals of slowed cognitive decline and plans to advance the drug into further trials. Diranersen is the first therapy of its kind to reach this stage, offering early proof of concept that reducing tau could have both biological and clinical effects. With two disease-modifying anti-amyloid therapies now available, tau presents an important opportunity for expanding Alzheimer's treatment options. These results come as the Alzheimer's pipeline continues to grow and evolve, with 75% of current trials now aimed at pathways beyond amyloid and tau, including inflammation, metabolic dysfunction, and oxidative stress. This broadening range of targets is critical to the future of Alzheimer's care, as the field moves toward combination approaches that can address multiple underlying causes of the disease in tandem. Topline data from the CELIA study will be presented at the upcoming Alzheimer's Association International Conference (AAIC), taking place July 12-16, 2026, in London.
お知らせ • May 15Biogen Announces Topline Results from Phase 2 Celia Study of Diranersen (Biib080)Biogen announced compelling topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease. CELIA did not meet its primary endpoint assessing dose response; based on the strength of the biomarker and efficacy data, Biogen plans to advance diranersen to registrational development. Robust reductions in tau pathology were observed across all studied doses, with results generally consistent with those observed in the Phase 1b study. Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly at the lowest dose. The safety and tolerability profile of diranersen was generally consistent with the Phase 1b study. CELIA is an 18-month Phase 2 randomized, placebo-controlled, dose-ranging study evaluating diranersen, a tau-targeting antisense oligonucleotide (ASO). Pre-specified analyses of cognitive endpoints demonstrated slowing of clinical decline across all studied doses, particularly in participants receiving the lowest dose of diranersen, 60 mg administered every 24 weeks. Diranersen also demonstrated robust reductions in both cerebrospinal fluid (CSF) tau and tau pathology, as measured by positron emission tomography (PET), across all studied doses, with reductions maintained throughout the dosing period. CELIA did not meet its primary endpoint assessing dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. The safety and tolerability profile of diranersen across all studied doses was generally consistent with the Phase 1b study and the known profile of diranersen to date. The incidence of adverse events (AEs) was comparable across dose groups, with a higher incidence of serious adverse events (SAEs) observed at the highest dose studied. CELIA is a pioneering study evaluating diranersen, a first-in-class investigational ASO designed to reduce the production of tau protein at its source in early Alzheimer’s disease. While tau plays an important role in the normal function of brain cells, in Alzheimer’s disease abnormal tau can accumulate and form intracellular tangles that contribute to neurodegeneration and cognitive decline. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both extracellular and intracellular tau. Diranersen (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 associated with neurodegeneration and cognitive decline. Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of 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 diranersen. Diranersen was discovered by Ionis. CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy. The study evaluated three doses of diranersen administered intrathecally over a 76-week placebo-controlled treatment period: 60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks. The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer’s disease.
お知らせ • May 11Eisai Co., Ltd. and Biogen Inc. Update on Fda Priority Review of Leqembi Iqlik (Lecanemab-Irmb) Subcutaneous Injection as A Starting Dose for Early Alzheimer's DiseaseEisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose. Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025. LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. 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 (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. 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. 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.
