Core Viewpoint - The European Commission has granted marketing authorization for Leqembi (lecanemab) to treat early Alzheimer's disease, marking a significant regulatory milestone for Biogen and Eisai [1][4][7]. Company Developments - Biogen's partner, Eisai, is responsible for the clinical development and regulatory submissions for Leqembi, although both companies co-commercialize the drug [2]. - Biogen's stock has decreased by 23.5% year-to-date, contrasting with a 6.5% decline in the industry [3]. Regulatory Approval Process - The approval for Leqembi followed a series of delays, including a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July 2024 [4][5]. - The CHMP initially raised concerns about the drug's safety, particularly regarding amyloid-related imaging abnormalities (ARIA) [6]. - After reassessing new safety data, the CHMP reaffirmed its positive opinion for Leqembi in February 2025 [9]. Market Performance - Leqembi has been approved in multiple countries, including the United States, China, Japan, and Great Britain [10]. - Sales of Leqembi showed a sequential improvement, with Eisai reporting nearly $87 million in global revenues in Q4 2024, reflecting a 30% increase [11]. Future Prospects - A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025, with a subcutaneous autoinjector under review [12]. - Both companies believe Leqembi has the potential to achieve blockbuster sales due to the significant unmet medical need for Alzheimer's treatments [12]. Competitive Landscape - Leqembi and Eli Lilly's Kisunla are currently the only two FDA-approved drugs for early symptomatic Alzheimer's disease [13]. - Both drugs target the reduction of amyloid beta (Aβ) plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [14].

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology [1][2] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][3] Company Overview - Eisai Co., Ltd. and Biogen Inc. are collaborating on the development and commercialization of lecanemab, with Eisai leading the global development and regulatory submissions [2][8] - The approval of lecanemab in the EU is the thirteenth approval globally, following its benefits to thousands of patients in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities and healthcare providers to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients with early Alzheimer's disease [4][6] - In the trial, lecanemab reduced clinical decline on the CDR-SB scale by 31% at 18 months compared to placebo [4][6] - The secondary endpoint showed a 33% less decline in daily living activities for patients treated with lecanemab compared to placebo [4][6] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, indicating a significant unmet need for effective treatments [1][6] - Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, which are key contributors to neuronal injury in Alzheimer's disease [1][4] - The approval of lecanemab represents a landmark advancement in a field that has seen little innovation over the past two decades [2][6]

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology Lecanemab is the first therapy that targets an underlying cause of the disease to be authorized in the EU for eligible people with early AD TOKYO and CAMBRIDGE, Mass., April 15, 2025 (GLOBE NEWSWIRE) -- Eisai C ...

Biogen Inc. (BIIB) shares rallied 5.7% in the last trading session to close at $120.49. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 20.6% loss over the past four weeks.The stock surged in response to the broader market rally after President Trump announced a 90-day pause on the sweeping tariffs against non-retaliating countries.This company is expected to post quarterly earnings of $3.59 per share in its ...

Biogen (BIIB) announced that the FDA has granted fast track designation to its investigational Alzheimer's disease (AD) drug, BIIB080.How Does the Fast Track Tag Benefit BIIB’s Drug Development?Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, fill an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earl ...

CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and address unmet medical needs. “We are encouraged by the F ...

Biogen signs lease for Kendall Common as part of multi-year real estate optimization plan to modernize its facilities and consolidate its Massachusetts real estate footprintNew building will be designed to foster collaboration and spark innovation; Biogen plans to relocate Cambridge-based employees to the new site in 2028 CAMBRIDGE, Mass., March 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) announced plans for its new global headquarters at Kendall Common, located at 75 Broadway in Cambridge, as pa ...

It has been about a month since the last earnings report for Biogen Inc. (BIIB) . Shares have added about 1.1% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is Biogen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.How Have Estimates Been Moving Since Then?It turns ou ...

Sales of Biogen’s (BIIB) key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza, are being hurt due to competitive pressure, which is resulting in declining total revenues. Biogen’s total revenues declined 2% in 2024. In 2025, total revenues are expected to decline by a mid-single-digit percentage in constant currency terms.Biogen believes that some of its new drugs, Eisai-partnered Leqembi for Alzheimer’s disease, Skyclarys for Friedreich’s atax ...

Biogen (BIIB) announced that dosing has begun in a phase III study evaluating its key pipeline candidate, felzartamab, in adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR).AMR is a leading cause of kidney transplant failure. AMR occurs in kidney transplant recipients when the antibodies of the immune system attack the transplanted kidney, causing damage to the kidney tissue.The   52-week, double-blind, placebo-controlled, multicenter, randomized TRANSCEND phase III stu ...