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Biogen (BIIB)
NASDAQ:BIIB
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Biogen (BIIB) AI Stock Analysis

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BIIB

Biogen

(NASDAQ:BIIB)

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Outperform 74 (OpenAI - 4o)
Rating:74Outperform
Price Target:
$168.00
▲(10.94% Upside)
Biogen's overall stock score reflects strong earnings call performance and technical indicators, supported by a solid financial foundation. While challenges in revenue growth and profitability exist, the company's strategic focus on new product launches and pipeline expansion provides a positive long-term outlook.
Positive Factors
Pipeline Advancements
Biogen's initiation of multiple Phase III studies indicates a robust pipeline, which is crucial for long-term growth and maintaining competitive advantage in the biotech industry.
Cash Flow Management
Strong cash flow management enhances Biogen's ability to invest in R&D and strategic initiatives, supporting sustainable growth and financial resilience.
Strategic Collaborations
Strategic collaborations, like the agreement with Vanqua, expand Biogen's portfolio and enhance its R&D capabilities, positioning it for long-term success in the biotech sector.
Negative Factors
Declining Profitability Margins
Declining profitability margins suggest challenges in cost management and operational efficiency, which could impact Biogen's long-term financial health and competitiveness.
MS Revenue Challenges
Competitive pressures in the MS market, particularly from generics, threaten Biogen's revenue streams and market position, potentially affecting long-term growth.
Arbitration with Eisai
The arbitration with Eisai highlights potential partnership challenges, which could disrupt strategic collaborations and impact Biogen's market strategy in Europe.

Biogen (BIIB) vs. SPDR S&P 500 ETF (SPY)

Biogen Business Overview & Revenue Model

Company DescriptionBiogen Inc. is a global biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 and headquartered in Cambridge, Massachusetts, Biogen focuses on areas such as multiple sclerosis, spinal muscular atrophy, and Alzheimer's disease, offering a range of products including well-known medications like Tecfidera, Avonex, and Spinraza. The company's commitment to research and development drives its pipeline of potential treatments, positioning it as a leader in the biotechnology sector.
How the Company Makes MoneyBiogen generates revenue primarily through the sale of its pharmaceutical products, particularly those used in treating neurological disorders. Key revenue streams include sales from its leading therapies such as Tecfidera, which is a top-selling oral treatment for multiple sclerosis, and Spinraza, a treatment for spinal muscular atrophy. The company also earns revenue from partnerships and collaborations with other pharmaceutical firms, as well as licensing agreements for its products. Additionally, Biogen invests heavily in research and development to bring new drugs to market, which can create future revenue opportunities. The company's strategic collaborations, particularly in the field of Alzheimer's disease, are significant factors contributing to its earnings potential.

Biogen Key Performance Indicators (KPIs)

Any
Any
Revenue by Segment
Revenue by Segment
Analyzes revenue from different business segments, highlighting which areas are driving growth and which may need strategic adjustments to enhance Biogen's overall performance.
Chart InsightsBiogen's revenue from the Multiple Sclerosis segment continues to decline, exacerbated by competitive pressures, particularly in Europe. However, the company's strategic focus on new product launches is paying off, with significant growth from products like LEQEMBI and VUMERITY. This shift is crucial as it offsets the MS portfolio's decline and supports Biogen's raised financial guidance for 2025. The positive sentiment from the earnings call highlights the potential for sustained growth driven by new launches and pipeline advancements, despite challenges in international markets and partnership issues.
Data provided by:Main Street Data

Biogen Earnings Call Summary

Earnings Call Date:Oct 30, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Jan 29, 2026
Earnings Call Sentiment Positive
Biogen's earnings call reflected a strong performance in new product launches and pipeline progress, with significant revenue growth in key segments offsetting some challenges, particularly in Europe and China. The financial results and strategic focus on pipeline expansion suggest a positive outlook.
Q3-2025 Updates
Positive Updates
Strong Revenue Growth in Launch Products
Biogen's launch products demonstrated a year-on-year growth of 67% in Q3 2025, significantly offsetting the decline in MS revenue.
LEQEMBI Sales and Global Demand
LEQEMBI continues to show strong global demand with Q3 sales of $121 million and positive feedback from customers and payers.
Pipeline Progress
Litifilimab Phase III studies in SLE are fully enrolled with expected readouts in 2026, indicating strong commercial potential.
ZURZUVAE Revenue Growth
ZURZUVAE saw a 19% revenue growth compared to the previous quarter, driven by increased demand and new prescribers.
Financial Performance
Biogen delivered a 3% revenue growth overall, with non-GAAP diluted EPS growth of 18% and $1.2 billion in free cash flow in Q3 2025.
Negative Updates
TECFIDERA Generic Erosion in Europe
Accelerated erosion in TECFIDERA revenue due to generic launches in Europe, including Germany, with a sequential net decrease of $28 million.
Challenges in China for LEQEMBI
Negligible LEQEMBI sales in China for Q3 due to a $35 million inventory build in the prior quarter, impacting current quarter sales.
U.S. SKYCLARYS Revenue Impact
In the U.S., SKYCLARYS revenue was impacted by a $6 million adjustment related to channel mix and IRA changes to Medicare.
Company Guidance
During Biogen's Third Quarter 2025 Earnings Call, the company provided guidance highlighting significant growth across its portfolio. Key metrics included a 67% year-over-year growth in launch products, with LEQEMBI sales reaching $121 million globally. SKYCLARYS showed a 30% revenue growth year-over-year, while ZURZUVAE achieved a remarkable 150% revenue growth in the same period. The company's late-stage pipeline is robust, with 10 Phase III or Phase III-ready programs, and they are expanding their early-stage pipeline with assets like BIIB142 for autoimmune diseases. The financial guidance was updated to reflect a stronger business outlook, with anticipated sales growth of up to 1% at constant currency and a focus on business development activities impacting non-GAAP EPS guidance by approximately $1.25 per share. Biogen also emphasized its commitment to delivering $1 billion in gross savings as part of the Fit-for-Growth initiative by the end of 2025.

Biogen Financial Statement Overview

Summary
Biogen's financial performance shows resilience with a strong balance sheet and improving cash flow generation. However, challenges in revenue growth and declining margins impact overall profitability. The company maintains a solid capital structure and effective cash management.
Income Statement
65
Positive
Biogen's income statement shows a mixed performance. The TTM gross profit margin is strong at 56.76%, but has decreased from previous years, indicating some pressure on cost management. The net profit margin is healthy at 15.98%, though it has declined from 29.95% in 2022. Revenue growth has been negative in recent years, but the TTM shows a slight recovery with a 0.69% increase. EBIT and EBITDA margins have also decreased, reflecting reduced operational efficiency.
Balance Sheet
70
Positive
The balance sheet indicates a stable financial position with a debt-to-equity ratio of 0.36 in the TTM, showing a decrease from previous years, which is positive. The return on equity has decreased to 9.25% in the TTM from 22.76% in 2022, suggesting reduced profitability. The equity ratio remains strong, indicating a solid capital structure.
Cash Flow
75
Positive
Cash flow analysis reveals a positive trend with a TTM free cash flow growth rate of 22.66%, indicating improved cash generation. The operating cash flow to net income ratio is 0.75, showing good cash conversion. The free cash flow to net income ratio is high at 0.93, suggesting efficient cash management.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue9.99B9.68B9.84B10.17B10.98B13.44B
Gross Profit7.00B7.37B7.30B7.90B8.87B11.64B
EBITDA3.49B3.00B2.38B3.54B3.92B5.11B
Net Income1.61B1.63B1.16B3.05B1.56B4.00B
Balance Sheet
Total Assets29.21B28.05B26.84B24.55B23.88B24.62B
Cash, Cash Equivalents and Short-Term Investments3.96B2.38B1.05B4.89B3.80B2.61B
Total Debt6.59B6.63B7.34B6.61B7.60B7.83B
Total Liabilities11.00B11.33B12.05B11.17B12.92B13.93B
Stockholders Equity18.21B16.72B14.80B13.40B10.90B10.70B
Cash Flow
Free Cash Flow2.28B2.52B1.24B1.14B3.38B3.81B
Operating Cash Flow2.45B2.88B1.55B1.38B3.64B4.23B
Investing Cash Flow-158.00M-799.20M-4.09B1.59B-563.70M-608.60M
Financing Cash Flow-157.00M-683.50M137.00M-1.76B-2.09B-5.27B

Biogen Technical Analysis

Technical Analysis Sentiment
Positive
Last Price151.44
Price Trends
50DMA
144.60
Positive
100DMA
137.67
Positive
200DMA
135.27
Positive
Market Momentum
MACD
1.85
Negative
RSI
57.25
Neutral
STOCH
80.96
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BIIB, the sentiment is Positive. The current price of 151.44 is above the 20-day moving average (MA) of 148.08, above the 50-day MA of 144.60, and above the 200-day MA of 135.27, indicating a bullish trend. The MACD of 1.85 indicates Negative momentum. The RSI at 57.25 is Neutral, neither overbought nor oversold. The STOCH value of 80.96 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for BIIB.

Biogen Risk Analysis

Biogen disclosed 30 risk factors in its most recent earnings report. Biogen reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Biogen Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
$92.67B13.0435.62%3.59%5.97%128.66%
$148.64B18.5740.62%2.62%2.71%6407.19%
$22.22B13.819.31%5.00%-1.03%
$160.66B24.4299.14%3.15%13.10%110.67%
$93.69B15.5433.84%5.39%1.26%
$374.44B159.253.01%7.40%
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BIIB
Biogen
151.44
-25.49
-14.41%
AMGN
Amgen
296.30
-12.66
-4.10%
BMY
Bristol-Myers Squibb
46.02
-7.28
-13.66%
GILD
Gilead Sciences
122.05
34.44
39.31%
GSK
GlaxoSmithKline
46.35
10.92
30.82%
ABBV
AbbVie
211.96
17.09
8.77%

Biogen Corporate Events

Biogen Inc. Reports Strong Q3 2025 Results
Oct 31, 2025

Biogen Inc. is a leading biotechnology company that focuses on developing innovative therapies for neurological and rare diseases, with a strong emphasis on leveraging scientific advancements to improve patient outcomes. In its latest earnings report, Biogen Inc. announced a robust financial performance for the third quarter of 2025, with total revenue reaching $2.5 billion, marking a 3% increase compared to the previous year. The company’s GAAP diluted earnings per share (EPS) rose by 19% to $3.17, while the non-GAAP diluted EPS increased by 18% to $4.81.

Biogen’s PMN Study: A Potential Game-Changer for Kidney Disease Treatment?
Oct 27, 2025

Biogen Inc. is currently conducting a clinical study titled An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]. The study aims to assess the effects and safety of felzartamab infusions in adults with PMN, a condition where autoantibodies damage the kidney’s filtering units, leading to potential kidney failure. The primary objective is to determine how many participants achieve a complete response after 104 weeks of treatment, with secondary objectives including the time to disease progression and the development of antibodies against felzartamab.

Biogen’s Felzartamab Trial: A New Hope for Kidney Transplant Patients
Oct 27, 2025

Study Overview: Biogen Inc. is conducting a Phase 3 trial titled A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR). The study aims to assess the effectiveness of felzartamab compared to a placebo in treating patients with late active or chronic active AMR, a significant complication in kidney transplant recipients.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment?
Oct 27, 2025

Biogen Inc. is conducting a Phase 3 long-term extension study titled A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus. The study aims to assess the long-term safety and efficacy of litifilimab in adults with active systemic lupus erythematosus (SLE) who have completed previous treatment periods in parent studies. The primary focus is on understanding adverse events and the drug’s impact on SLE symptoms.

Biogen’s Litifilimab Study: A Promising Step for Lupus Treatment
Oct 27, 2025

Biogen Inc. is conducting a Phase 3 study titled ‘A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus.’ The study aims to evaluate the long-term safety and efficacy of litifilimab in adults with active subacute or chronic cutaneous lupus erythematosus, particularly those unresponsive or intolerant to antimalarial therapy. This research is significant as it seeks to provide a viable treatment option for patients with limited alternatives.

Biogen’s New Study on Felzartamab: A Potential Game-Changer for Kidney Transplant Patients
Oct 27, 2025

Biogen Inc. is conducting a clinical study titled A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI). The study aims to assess the effects of felzartamab on kidney inflammation in patients who have undergone kidney transplants and developed MVI, a condition that can lead to serious kidney issues. The primary objective is to determine how many participants show no signs of active inflammation after 24 weeks of treatment.

Biogen’s Study on Diroximel Fumarate: A Closer Look at Pregnancy Outcomes
Oct 27, 2025

Biogen Inc. is conducting a study titled Pregnancy Outcomes in Women Exposed to Diroximel Fumarate, aiming to assess the safety of Diroximel Fumarate (VUMERITY®) in pregnant women with multiple sclerosis (MS) and the health of their babies. The study’s primary goal is to gather data on major congenital malformations and other pregnancy outcomes in three groups: those exposed to Diroximel Fumarate, those on other MS drugs, and those on no MS drugs during pregnancy.

Biogen’s Promising Study on Litifilimab for Lupus: A Potential Game-Changer
Oct 27, 2025

Biogen Inc. is conducting a 2-part clinical study titled ‘A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST).’ The study aims to assess the efficacy and safety of litifilimab (BIIB059) in reducing skin disease activity in participants with cutaneous lupus erythematosus (CLE) who have not responded to antimalarial therapy.

Biogen’s Felzartamab Study: A Potential Game-Changer for IgA Nephropathy
Oct 27, 2025

Biogen Inc. is conducting a Phase 3 study titled ‘A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL).’ The study aims to evaluate the effects of felzartamab on proteinuria in adults with Immunoglobulin A Nephropathy (IgAN), a kidney condition. The primary objective is to assess changes in protein levels in urine over 36 weeks, alongside evaluating the drug’s safety and kidney filtration effects.

Biogen’s Litifilimab Study: A Potential Game-Changer in Lupus Treatment?
Oct 27, 2025

Biogen Inc. is conducting a Phase 3 clinical study titled A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care. The study aims to assess the safety and efficacy of litifilimab in reducing disease activity in adults with systemic lupus erythematosus (SLE) who are already on standard treatments. The primary goal is to determine how many participants show symptom improvement after 52 weeks of treatment.

Biogen’s New Study on Omaveloxolone: A Potential Game-Changer for Young Patients with Friedreich’s Ataxia
Oct 27, 2025

Biogen Inc. is conducting a clinical study titled An Open-Label, Phase 1, Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, and Efficacy of Omaveloxolone in Participants ≥2 to <16 Years of Age With Friedreich's Ataxia. The study aims to understand how the drug BIIB141, also known as omaveloxolone, is processed in the bodies of children and teens aged 2 to 15 with Friedreich's Ataxia, a condition for which the drug is already approved for those 16 and older.

Biogen’s Nusinersen Study: Exploring Pregnancy Outcomes in SMA Patients
Oct 27, 2025

Biogen Inc. is currently conducting a study titled ‘Spinraza (Nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries.’ The study aims to understand the effects of the drug nusinersen, known as Spinraza®, on pregnant participants with spinal muscular atrophy (SMA) and the health of their babies. This research is significant as it seeks to fill the knowledge gap regarding the impact of nusinersen on pregnancy outcomes and infant health in SMA patients.

Biogen’s Innovative Approach in SMA Treatment: ThecaFlex DRx™ System Study Update
Oct 27, 2025

Biogen Inc., in collaboration with Alcyone Therapeutics, is conducting a clinical study titled ‘Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and Delivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar Puncture Trial (PIERRE)’. The study aims to evaluate the safety and performance of the ThecaFlex DRx™ System in delivering nusinersen to patients with spinal muscular atrophy (SMA) who are resistant to lumbar puncture. This study is significant as it seeks to improve treatment delivery for SMA patients facing challenges with traditional methods.

Biogen’s New Study on Omaveloxolone: A Potential Game-Changer for Friedreich’s Ataxia
Oct 27, 2025

Biogen Inc. is conducting a Phase 3 clinical study titled A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled Study (Part 1) and Open-Label Extension (Part 2) to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich’s Ataxia Aged 2 to < 16 Years. The study aims to assess the effects and long-term safety of BIIB141, also known as omaveloxolone, in children and teens with Friedreich's Ataxia (FA) aged 2 to 15 years. This research is significant as the drug is currently approved for those aged 16 and older, and this study could expand its use to a younger demographic.

Biogen’s BIIB142 Study: A New Chapter in Drug Safety Evaluation
Oct 27, 2025

Biogen Inc. is conducting a Phase 1 clinical trial to evaluate the safety and processing of BIIB142 in healthy adults aged 18 to 55. Officially titled ‘A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults,’ the study aims to determine the occurrence of adverse events and how the body processes the drug. This study is significant as it marks the first time BIIB142 is being tested in humans.

Biogen’s Innovative Approach to SMA Treatment: A Study Update
Oct 27, 2025

Biogen Inc. is conducting a study titled ‘An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered Via the ThecaFlex DRx™ System (PIERRE-PK).’ The study aims to understand how nusinersen, a treatment for spinal muscular atrophy (SMA), is processed by the body when delivered through the ThecaFlex DRx™ System compared to traditional lumbar puncture. This research is significant as it could improve treatment delivery methods for SMA patients.

Biogen’s Innovative Study on Litifilimab Delivery: Market Implications and Study Insights
Oct 27, 2025

Biogen Inc. is currently conducting a study titled A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants. The study aims to understand how the body processes litifilimab when delivered subcutaneously through different devices, focusing on pharmacokinetic comparability.

Biogen’s Pregnancy Exposure Study: Implications for MS Treatment Market
Oct 27, 2025

Biogen Inc. is currently recruiting participants for a study titled ‘Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry.’ The study aims to assess the risk of major congenital malformations in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) during pregnancy. It also compares pregnancy outcomes with women exposed to other disease-modifying therapies (DMTs) or unexposed to any DMTs.

Biogen’s Zuranolone Study: A Potential Game-Changer for Postpartum Depression Treatment
Oct 27, 2025

Biogen Inc. is currently conducting a study titled ‘Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting.’ The study aims to understand how zuranolone affects postpartum depression (PPD) symptoms in individuals who have taken the drug within a year after pregnancy. This research is significant as it seeks to provide insights into the real-world effectiveness of zuranolone, a treatment option for PPD, which can severely impact new parents’ mental health.

Biogen and Denali’s New Study on LRRK2-Associated Parkinson’s Disease: What Investors Need to Know
Oct 27, 2025

Biogen Inc. and Denali Therapeutics have launched a Phase 2a study titled ‘A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD).’ The study aims to assess the safety, tolerability, and pharmacodynamic effects of BIIB122 in individuals with LRRK2-PD, a form of Parkinson’s Disease linked to a genetic variant that increases LRRK2 kinase activity.

Biogen’s Omaveloxolone Study: Assessing Safety During Pregnancy and Lactation
Oct 27, 2025

Biogen Inc. is conducting a study titled A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation. The study aims to evaluate the safety of BIIB141 (Omaveloxolone) for individuals with Friedrich’s Ataxia who took the drug during pregnancy and/or breastfeeding, focusing on potential birth defects and maternal health complications.

Biogen’s New MS Study: A Potential Game-Changer for Investors?
Oct 27, 2025

Biogen Inc. is conducting a clinical study titled ‘A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis.’ The study aims to assess the safety of BIIB091, both alone and in combination with Diroximel Fumarate (DRF), in adults with relapsing forms of Multiple Sclerosis (MS). This research is significant as it seeks to understand the safety profile and impact on brain inflammation of these treatments, potentially offering new therapeutic options for MS patients.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment?
Oct 27, 2025

Study Overview: Biogen Inc. is conducting a Phase 3 clinical study titled A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care. The study aims to assess the efficacy and safety of litifilimab in reducing disease activity in adults with systemic lupus erythematosus (SLE) who are already on standard care medications.

Biogen’s Omaveloxolone Study: A Closer Look at Long-Term Safety for Friedreich’s Ataxia
Oct 27, 2025

Biogen Inc. is conducting a study titled An Observational, Multinational, Post-Marketing Registry of Omaveloxolone-Treated Patients With Friedreich’s Ataxia to evaluate the long-term safety of BIIB141, known as omaveloxolone or SKYCLARYS®. The study aims to gather safety data on patients with Friedreich’s Ataxia (FA) who are prescribed this drug by their doctors, focusing on serious adverse events and those related to heart failure or liver damage.

Biogen’s Innovative Study on Litifilimab Delivery: Market Implications and Study Insights
Aug 22, 2025

Biogen Inc. is conducting a study titled A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants. The study aims to understand how the body processes litifilimab when administered under the skin using different devices, which could improve delivery methods for patients with limited dexterity or needle phobia.

Biogen’s Phase 3 Study on Felzartamab: A Potential Game-Changer for IgA Nephropathy
Aug 22, 2025

Biogen Inc. (BIIB) is currently conducting a Phase 3 study titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL). The study aims to evaluate the effects of felzartamab on proteinuria in patients with Immunoglobulin A Nephropathy (IgAN), a kidney condition that leads to protein in urine due to kidney damage.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment?
Aug 22, 2025

Biogen Inc. (BIIB) is conducting a Phase 3 long-term extension study titled ‘A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus.’ The study aims to assess the long-term safety and efficacy of litifilimab in adults with active systemic lupus erythematosus (SLE), focusing on adverse events, symptom control, and quality of life.

Biogen’s Promising Phase 3 Trial: Felzartamab for Kidney Transplant Rejection
Aug 21, 2025

Biogen Inc. is currently conducting a significant Phase 3 clinical trial titled ‘A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)’. The primary objective of this study is to assess the efficacy of felzartamab, a promising therapeutic agent, in treating kidney transplant recipients experiencing late antibody-mediated rejection.

Biogen’s Phase 3 Study on Felzartamab: A Potential Game-Changer for IgA Nephropathy
Aug 20, 2025

Biogen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL).’ The study aims to assess the effects of felzartamab on proteinuria and kidney function in adults with Immunoglobulin A Nephropathy (IgAN), a condition characterized by protein in the urine due to kidney damage.

Biogen’s Innovative Litifilimab Study: A Potential Game-Changer in Drug Delivery
Aug 20, 2025

Biogen Inc. (BIIB) is conducting a study titled A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants. The study aims to evaluate how the body processes litifilimab when administered under the skin using three different devices, focusing on pharmacokinetic comparability, safety, and tolerability.

Biogen’s New Clinical Trial: A Potential Game-Changer for Kidney Transplant Patients
Aug 15, 2025

Biogen Inc. has initiated a Phase 3 clinical trial titled A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR). The study aims to assess the effectiveness of felzartamab, a drug intended to treat late active or chronic active antibody-mediated rejection in kidney transplant patients, compared to a placebo.

Biogen’s Omaveloxolone Study: A New Hope for Young FA Patients
Aug 15, 2025

Biogen Inc. (BIIB) is conducting a significant clinical study titled A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich’s Ataxia Aged 2 to < 16 Years. The study aims to explore the effects and long-term safety of BIIB141, also known as omaveloxolone, in children and teens with Friedreich's Ataxia (FA), a condition for which the drug is currently approved only for individuals aged 16 and older.

Biogen’s Litifilimab Study: A Long-Term Look at Lupus Treatment
Aug 15, 2025

Biogen Inc. (BIIB) is conducting a Phase 3 long-term extension study titled A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus. The study aims to assess the long-term safety and efficacy of litifilimab, a drug intended to manage symptoms of systemic lupus erythematosus (SLE) in adults who have completed previous treatment periods. This study is significant as it seeks to provide insights into the drug’s safety profile and its potential to improve patient outcomes over an extended period.

Biogen’s Felzartamab Study: A Potential Game-Changer for IgA Nephropathy
Aug 14, 2025

Biogen Inc. (BIIB) is conducting a Phase 3 study titled ‘A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL).’ The study aims to evaluate the effects of felzartamab on proteinuria in patients with immunoglobulin A nephropathy (IgAN), a condition that causes protein leakage into urine due to kidney damage. The significance lies in potentially improving kidney function and patient outcomes.

Biogen’s Felzartamab Trial: A Potential Game-Changer for Kidney Transplant Treatments
Aug 13, 2025

Biogen Inc. is currently recruiting participants for a Phase 3 trial titled A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR). The study aims to assess the effectiveness of felzartamab, a drug administered via intravenous infusion, in treating kidney transplant recipients with late active or chronic active AMR, compared to a placebo.

Biogen’s PREVAIL Study: A New Hope for IgA Nephropathy Treatment?
Aug 12, 2025

Biogen Inc. (BIIB) is currently recruiting participants for a Phase 3 clinical study titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL). The study aims to evaluate the effects of felzartamab on proteinuria in adults with Immunoglobulin A nephropathy (IgAN), a condition characterized by kidney damage leading to protein in the urine. The primary objective is to assess the change in protein levels in urine over 36 weeks, alongside evaluating kidney function and the safety profile of felzartamab.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment
Aug 11, 2025

Biogen Inc. (BIIB) is conducting a Phase 3 long-term extension study titled A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus. The study aims to assess the long-term safety and efficacy of litifilimab in adults with active systemic lupus erythematosus (SLE), focusing on adverse events and symptom control.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment
Aug 8, 2025

Biogen Inc. (BIIB) is conducting a Phase 3 clinical study titled A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus. The study aims to evaluate the long-term safety and efficacy of litifilimab in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), particularly those unresponsive or intolerant to antimalarial therapy.

Biogen’s PIERRE-PK Study: A New Approach to Nusinersen Delivery in SMA
Aug 8, 2025

Biogen Inc. (BIIB) is conducting the PIERRE-PK study to evaluate how the body processes the drug nusinersen when administered through the ThecaFlex DRx™ System compared to the traditional lumbar puncture method. This study aims to determine the highest concentration of nusinersen in the blood post-dosing and its presence over a 24-hour period. The ThecaFlex DRx™ System, developed by Alcyone Therapeutics, Inc., is an investigational implantable device designed to improve drug delivery in patients with spinal muscular atrophy (SMA).

Biogen’s Innovative Approach to SMA Treatment: ThecaFlex DRx™ System Study Update
Aug 8, 2025

Biogen Inc. (BIIB), in collaboration with Alcyone Therapeutics, is conducting a pivotal clinical study titled ‘Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and Delivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar Puncture Trial (PIERRE)’. The study aims to evaluate the safety and efficacy of the ThecaFlex DRx™ System in delivering nusinersen to SMA patients, potentially supporting a Pre-Market Approval (PMA) application.

Biogen’s Litifilimab Study: A Potential Game-Changer for Lupus Treatment?
Aug 7, 2025

Biogen Inc. (BIIB) is currently conducting a clinical study titled ‘A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)’. The study aims to assess the efficacy and safety of litifilimab (BIIB059) in reducing skin disease activity in participants with cutaneous lupus erythematosus (CLE) who have not responded to antimalarial therapy.

Biogen Inc. Earnings Call Highlights Strong Growth and Raised Guidance
Aug 2, 2025

Biogen Inc. Reports Strong Quarter with Positive Earnings Call Sentiment

Biogen’s New Study on Vumerity: Potential Market Impact
Aug 1, 2025

Biogen Inc. has launched a new clinical study titled ‘Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry.’ The study aims to assess the risk of major congenital malformations in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) during pregnancy. It also compares these outcomes with those in women exposed to other disease-modifying therapies (DMTs) or none at all, as well as with women without MS.

Biogen’s Phase 3 Trial on Felzartamab: A Potential Game-Changer for Kidney Transplant Recipients
Aug 1, 2025

Biogen Inc. has initiated a Phase 3 clinical trial titled ‘A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)’. The study aims to assess the effectiveness of felzartamab compared to a placebo in treating late active or chronic active AMR in kidney transplant recipients, a significant concern in transplant medicine.

Biogen Reports Strong Q2 2025 Results, Raises Guidance
Aug 1, 2025

Biogen Inc. is a leading biotechnology company focused on developing innovative therapies for neurological and rare diseases, leveraging its deep understanding of human biology to deliver transformative medicines.

Biogen’s Litifilimab Study: A Long-Term Hope for Lupus Treatment
Jul 31, 2025

Biogen Inc. is conducting a Phase 3 long-term extension study titled A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus. The study aims to assess the long-term safety and efficacy of litifilimab, focusing on its impact on the symptoms and disease activity of systemic lupus erythematosus (SLE) in adults already on standard care medications. This research is significant as it seeks to provide insights into the long-term treatment potential of litifilimab for SLE.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
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Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Oct 31, 2025