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].

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 ...

Core Viewpoint - Biogen Inc. has seen a slight increase in share price of approximately 1.1% since the last earnings report, outperforming the S&P 500, but there are concerns about potential downward trends leading up to the next earnings release [1]. Group 1: Earnings Estimates - Estimates for Biogen have trended downward over the past month, with a consensus estimate shift of -9.02% [2]. - The overall direction and magnitude of estimate revisions indicate a downward shift, leading to a Zacks Rank of 3 (Hold) for Biogen, suggesting an expectation of in-line returns in the coming months [4]. Group 2: VGM Scores - Biogen currently holds a subpar Growth Score of D, a Momentum Score of C, and an impressive Value Score of A, placing it in the top 20% for value investment strategy [3]. - The aggregate VGM Score for Biogen is C, which is relevant for investors not focused on a single strategy [3]. Group 3: Industry Performance - Biogen is part of the Zacks Medical - Biomedical and Genetics industry, where Gilead Sciences has gained 7% over the past month [5]. - Gilead reported revenues of $7.57 billion for the last quarter, reflecting a year-over-year increase of +6.4%, with an EPS of $1.90 compared to $1.72 a year ago [5]. - Gilead is expected to post earnings of $1.73 per share for the current quarter, indicating a year-over-year change of +231.1%, and has a Zacks Rank of 2 (Buy) with a VGM Score of B [6].

Core Insights - Biogen's key multiple sclerosis drugs, including Tecfidera and Tysabri, along with Spinraza for spinal muscular atrophy, are facing declining sales due to increased competition, leading to a 2% decline in total revenues in 2024, with a projected mid-single-digit percentage decline in 2025 [1][4][6] Group 1: Revenue Declines - Biogen's global MS revenues declined by 7% in 2024, with expectations of a steeper decline in 2025 due to the potential entry of Tysabri biosimilars in the U.S. and generic versions of Tecfidera in Europe [4] - Spinraza sales fell nearly 10% in 2024, attributed to competitive pressure and decreased demand, with little improvement anticipated in 2025 [4][10] Group 2: Competitive Landscape - The launch of multiple generic versions of Tecfidera in North America, Brazil, and Europe has negatively impacted its revenues [3] - Regulatory approvals for biosimilars of Tysabri in the U.S. and Europe are contributing to the competitive pressure faced by Biogen [3][5] Group 3: New Drug Potential - Biogen is optimistic about new drugs like Leqembi for Alzheimer's, Skyclarys for Friedreich's ataxia, and Zurzuvae for depression, which are seen as potential drivers for long-term growth [2][8] - Leqembi has shown sequential improvement in sales since its launch, with expectations for continued growth in 2025 [7][8] Group 4: Market Challenges - The FDA approval of Eli Lilly's Alzheimer's drug Kisunla poses significant competition to Leqembi [5] - Foreign exchange headwinds are expected to negatively impact 2025 revenues by 1%, alongside a projected $50 million to $100 million impact from the redesign of Medicare Part D [6] Group 5: Pipeline Developments - Biogen faced setbacks in its pipeline, including the discontinuation of Zurzuvae's development for major depressive disorder, which had a larger market potential than its current indication [5] - The acquisition of Reata Pharmaceuticals added Skyclarys to Biogen's portfolio, which is experiencing strong launch trends [9]

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 ...

Core Viewpoint - Biogen has initiated the Phase 3 TRANSCEND clinical study to evaluate the efficacy and safety of felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR) [1][2]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create value for shareholders and communities [8]. - The company acquired Human Immunology Biosciences (HI-Bio) in July 2024, which holds exclusive rights to develop and commercialize felzartamab across various indications [4]. Drug Development - Felzartamab is an investigational human monoclonal antibody targeting CD38, with potential applications in various immune-mediated diseases [4]. - The Phase 3 TRANSCEND study will enroll approximately 120 kidney transplant recipients and is designed as a two-part, 52-week, double-blind, placebo-controlled trial [1][2]. - The primary endpoint of the study is the percentage of participants achieving resolution of AMR by biopsy at 6 months, with key secondary endpoints including changes in microvascular inflammation (MVI) score [2][5]. Market Context - AMR is a significant challenge in kidney transplantation, with around 23,000 patients in the U.S. affected by various forms of AMR [5]. - Current treatment options for late AMR are limited, highlighting the potential importance of felzartamab as a new therapeutic option if approved [2][7]. Future Plans - In addition to the TRANSCEND study, Biogen plans to initiate Phase 3 trials of felzartamab for IgA nephropathy and primary membranous nephropathy in 2025 [3]. - MorphoSys, the original developer of felzartamab, will receive a one-time milestone payment of $35 million from Biogen as part of the trial initiation [3].

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November 2024.1 Following CHMP's reaffirmation, ...

Biogen TodayBIIBBiogen$136.54 -0.04 (-0.03%) 52-Week Range$128.51▼$238.00P/E Ratio12.20Price Target$211.85Add to WatchlistBiogen Inc. NASDAQ: BIIB has steadily declined since peaking at $468.55 in 2021, as shares are trading down 70.64% from those highs to 12-year lows at $137.33. The medical sector biotechnology company is trading at historically low valuations at a 12.41 price-earnings (P/E) ratio, which is less than half of the industry average P/E of 29.52. Its price-book (P/B) ratio is 1.2, significan ...