View ValuationThis company listing is no longer activeThis company may still be operating, however this listing is no longer active.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 将来の成長Future 基準チェック /26Biogen利益と収益がそれぞれ年間13.8%と2.4%増加すると予測されています。EPS は年間 増加すると予想されています。自己資本利益率は 3 年後に12.5% 14.4%なると予測されています。主要情報13.8%収益成長率14.36%EPS成長率Biotechs 収益成長22.5%収益成長率2.4%将来の株主資本利益率12.51%アナリストカバレッジGood最終更新日28 May 2026今後の成長に関する最新情報更新なしすべての更新を表示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.業績と収益の成長予測BATS-CHIXE:IDPD - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/202810,6172,1362,4113,3601712/31/202710,3251,9502,6072,6392212/31/202610,0231,1222,6691,768223/31/20269,9371,3722,3162,591N/A12/31/20259,8911,2931,9692,205N/A9/30/202510,0661,6092,2622,454N/A6/30/20259,9971,5311,8322,117N/A3/31/20259,8161,4792,3842,582N/A12/31/20249,6761,6322,6042,876N/A9/30/20249,6081,6151,8572,127N/A6/30/20249,6721,1591,5711,784N/A3/31/20249,6631,1671,2841,645N/A12/31/20239,8361,1611,2361,547N/A9/30/20239,9931,4621,0261,360N/A6/30/20239,9722,6651,1231,428N/A3/31/202310,1053,1311,4211,678N/A12/31/202210,1733,0471,1411,384N/A9/30/202210,3632,8652,1732,398N/A6/30/202210,6342,0592,3152,542N/A3/31/202210,8201,4502,7733,033N/A12/31/202110,9821,5563,3453,640N/A9/30/202111,1011,5462,1072,435N/A6/30/202111,6981,9182,4612,810N/A3/31/202112,6043,0123,1493,532N/A12/31/202013,4454,0013,6784,230N/A9/30/202014,2635,0825,8416,557N/A6/30/202014,4875,9276,3497,071N/A3/31/202014,4225,8796,2827,086N/A12/31/201914,3785,889N/A7,079N/A9/30/201914,2335,396N/A7,014N/A6/30/201914,0725,294N/A7,055N/A3/31/201913,8124,667N/A6,190N/A12/31/201813,4534,431N/A6,188N/A9/30/201813,2343,187N/A5,811N/A6/30/201812,8722,968N/A5,703N/A3/31/201812,5942,964N/A5,773N/A12/31/201712,2742,539N/A4,551N/A9/30/201711,8393,486N/A4,615N/A6/30/201711,7173,293N/A3,978N/A3/31/201711,5333,480N/A3,807N/A12/31/201611,4493,703N/A4,587N/A9/30/201611,4163,885N/A4,046N/A6/30/201611,2383,818N/A3,950N/A3/31/201610,9363,695N/A3,999N/A12/31/201510,7643,547N/A3,919N/A9/30/201510,5653,599N/A3,609N/A6/30/201510,2993,490N/A3,627N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: IDPDの予測収益成長率 (年間13.8% ) は 貯蓄率 ( 3.4% ) を上回っています。収益対市場: IDPDの収益 ( 13.8% ) はUK市場 ( 11.5% ) よりも速いペースで成長すると予測されています。高成長収益: IDPDの収益は増加すると予測されていますが、大幅には増加しません。収益対市場: IDPDの収益 ( 2.4% ) UK市場 ( 4.5% ) よりも低い成長が予測されています。高い収益成長: IDPDの収益 ( 2.4% ) 20%よりも低い成長が予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: IDPDの 自己資本利益率 は、3年後には低くなると予測されています ( 12.5 %)。成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance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 21:01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.