Wall Street analysts forecast that Biogen Inc. (BIIB) will report quarterly earnings of $3.32 per share in its upcoming release, pointing to a year-over-year decline of 9.5%. It is anticipated that revenues will amount to $2.23 billion, exhibiting a decline of 2.6% compared to the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted upward by 0.1% to its current level. This demonstrates the covering analysts' collective reassessment of their initial projection ...

Biogen Inc. ( BIIB ) is a solid profit-generating company that has seen significant declines in its earnings and share price over the past few years, particularly due to declining revenue from their legacy Multiple Sclerosis treatments. TheirI have been investing in the stock market since I was 17 years old, and over the 25+ years since I have learned the joy of compounding, the value of dividend reinvesting, and the principle that patient investing through good times and bad brings the greatest rewards. I ...

The market expects Biogen Inc. (BIIB) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 1, 2025, might help the stock move higher if these key numbers are better ...

Biogen (BIIB) will report first-quarter 2025 results on May 1, before market open. In the last reported quarter, the company's earnings beat expectations by 0.58%. The Zacks Consensus Estimate for first-quarter sales and earnings is pegged at $2.24 billion and $3.34 per share, respectively. (Find the latest earnings estimates and surprises on Zacks Earnings Calendar.)Factors to Consider for BiogenIn the first quarter, lower sales of multiple sclerosis (“MS”) drugs are likely to have been offset by revenues ...

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 ...

Core Viewpoint - The FDA has granted Fast Track designation to Biogen's investigational therapy BIIB080 for Alzheimer's disease, highlighting the urgent need for innovative treatments targeting tau pathology [1][2]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on pioneering innovative science to deliver new medicines and create value for shareholders and communities [5]. Product Development - BIIB080 is the first tau-targeting antisense oligonucleotide (ASO) therapy in clinical development for Alzheimer's disease, currently evaluated in the global Phase 2 CELIA study for individuals with early-stage disease [2][3]. - Previous Phase 1b study results indicated dose-dependent reductions in soluble tau protein in cerebrospinal fluid and decreases in aggregated tau pathology in the brain, with favorable trends in exploratory clinical outcomes [2][3]. - The Phase 2 CELIA study is fully enrolled, with data readout expected in 2026 [2]. Licensing and Collaboration - In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals to obtain a worldwide, exclusive, royalty-bearing license for the development and commercialization of BIIB080 [4].