Track market-moving stories before they get noisy

Biogen Inc. (BIIB - Free Report) shares soared 5.3% in the last trading session to close at $253.84. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 5.9% gain over the past four weeks.

Biogen’s share price gain can likely be attributed to the growing investor optimism surrounding its pipeline progress and upcoming clinical milestones. Positive long-term phase II data from the ongoing AMETHYST study for litifilimab in cutaneous lupus erythematosus, showing sustained skin improvement through 52 weeks, has strengthened confidence in the drug’s potential. Data from phase III portion of the study are expected in the first half of 2027. Investors are also watching felzartamab’s development in kidney diseases, with phase III data expected in 2027, and upcoming phase III results for litifilimab in systemic lupus erythematosus (SLE), anticipated by year-end 2026.

This company is expected to post quarterly earnings of $2.08 per share in its upcoming report, which represents a year-over-year change of -56.8%. Revenues are expected to be $2.59 billion, up 2% from the year-ago quarter.

Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price movements.

For Biogen, the consensus EPS estimate for the quarter has been revised 1.8% lower over the last 30 days to the current level. And a negative trend in earnings estimate revisions doesn't usually translate into price appreciation. So, make sure to keep an eye on BIIB going forward to see if this recent jump can turn into more strength down the road.

The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>

Biogen is part of the Zacks Medical - Biomedical and Genetics industry. Novavax (NVAX - Free Report) , another stock in the same industry, closed the last trading session 9.3% lower at $9.99. NVAX has returned 4.4% in the past month.

For Novavax, the consensus EPS estimate for the upcoming report has changed -8.1% over the past month to -$0.33. This represents a change of +46.8% from what the company reported a year ago. Novavax currently has a Zacks Rank of #3 (Hold).

Biogen (BIIB) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

On October 20, 2026, Biogen Inc BIIB shares rose 4.1% to a current price of $243.10. This increase comes in the context of a 52-week range that saw lows of $138.00 and highs of $240.99.

GF Value™ verdict: The stock is currently priced at $243.10, which is 20.3% above the GF Value™ estimate of $202.16, indicating it is overvalued.GF Score™: The company has a GF Score™ of 73/100, categorizing it as above average.Notable signal: Over the past 12 months, insiders have sold $0.9M worth of shares, reflecting a net selling trend.Is BIIB Overvalued or Undervalued?The current price of Biogen Inc BIIB at $243.10 is significantly above the GF Value™ estimate of $202.16, resulting in a 20.3% overvaluation. This GF Value™ estimate is derived from a comprehensive analysis of historical trading multiples, past business performance, and projections for future growth. Being overvalued suggests a potential risk for investors, as a correction could occur if the market adjusts to align the stock price more closely with its intrinsic value.

In this context, the GF Valuation label indicates that Biogen is modestly overvalued. The margin of safety appears limited, which implies that investors may not have a sufficient buffer against potential declines in share price. This suggests that caution should be exercised when considering the stock, as the current valuation may not support continued upward momentum in the absence of substantial positive developments.

How Does BIIB's Valuation Compare to Its History?MetricCurrentHistoricalP/E (TTM)43.0x17.9xForward P/E15.0xN/ABiogen's current P/E ratio of 43.0x is 141% above its 5-year median of 17.9x, indicating that the stock is trading at a significantly higher multiple than it has historically. This P/E analysis aligns with the GF Value™ verdict, reinforcing the notion that the stock is overvalued. The forward P/E of 15.0x suggests that analysts may expect improved earnings in the future, but given the current high multiple, it may not justify the present price.

What Does BIIB's GF Score™ Tell Us?The GF Score™ provides a comprehensive assessment of a company's financial health, growth prospects, and valuation by evaluating several key factors. Biogen's GF Score™ of 73/100 indicates it falls within the above-average category, with specific strengths and weaknesses in various sub-ranks.

MetricRatingGF Score™73Financial Strength6/10Profitability7/10Growth3/10Valuation6/10Momentum6/10Biogen's strongest area lies in its profitability rank of 7/10, suggesting solid profit margins and return metrics. Conversely, the growth rank of 3/10 highlights challenges in expanding revenue and earnings, which can be a concern for long-term investors. The financial strength rating of 6/10 indicates a balanced but cautious approach to leverage and liquidity.

What Are Gurus and Insiders Doing with BIIB?Currently, 12 gurus hold shares of Biogen Inc BIIB , with 4 adding to their positions and 9 trimming their holdings in recent quarters. This mixed activity reflects a divided sentiment among institutional investors regarding the stock’s future prospects. Such dynamics are crucial for understanding market sentiment, as guru ownership can often signal confidence or caution about a stock's outlook.

Insider activity shows that in the past 12 months, there has been $0.0M in purchases and $0.9M in sales, resulting in net selling. This trend of insider selling may suggest that those closest to the company are not optimistic about short-term growth prospects or may want to take profits at current valuations. Such insider behavior can serve as a warning sign for potential investors.

What This Means for InvestorsIn summary, Biogen Inc BIIB appears to be overvalued based on its current price compared to the GF Value™ estimate. With the stock trading significantly above its historical valuation metrics and a net selling trend from insiders, prospective investors may want to approach the stock with caution. To explore more about Biogen Inc and its financial metrics, visit the Biogen Inc (BIIB) stock page.

Frequently Asked QuestionsWhat is BIIB's GF Score™?

Biogen Inc has a GF Score™ of 73/100, indicating that it is performing above average in terms of financial health and growth potential.

Is BIIB overvalued or undervalued?

Based on the GF Value™ estimate, Biogen Inc is currently overvalued by 20.3%, as its price exceeds the intrinsic value derived from the analysis.

What is BIIB's P/E ratio?

Biogen's P/E ratio is 43.0x, which is significantly higher than its 5-year median of 17.9x, indicating it is trading at a premium compared to its historical valuation.

This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].

Two oral presentations to highlight new 76-week data showing sustained proteinuria reduction and continued eGFR stabilization with a consistent long-term safety profileAdditional presentations to highlight nephrologist perspectives on gaps in current care practices and limited treatment options for antibody-mediated rejection (AMR)Presentations on the role of felzartamab, an investigational anti-CD38 monoclonal antibody, in multiple immune-mediated kidney diseases will also be featured
CAMBRIDGE, Mass., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) will present new EMPAVELI® (pegcetacoplan) data and additional scientific presentations from its nephrology portfolio, including investigational felzartamab, at the American Society of Nephrology (ASN) Kidney Week taking place from October 22 to 25, 2026 in Denver, Colorado.

Key presentations include new EMPAVELI data showing sustained proteinuria reduction and continued estimated glomerular filtration rate (eGFR) stabilization in patients with C3G and primary IC-MPGN over 76 weeks. This data follows the recent U.S. Food and Drug Administration update to expand EMPAVELI’s indication to include reducing the loss of kidney function, making it the first and only therapy approved to reduce both proteinuria and the loss of kidney function in adults and adolescents aged 12 years and older with C3G and primary IC-MPGN. Additional presentations on pegcetacoplan and felzartamab will provide insights into the management and understanding of multiple immune-mediated kidney diseases.

“Data shared this week further reinforce EMPAVELI’s long-term efficacy and safety profile, while new scientific insights highlight the significant unmet needs and lack of proven therapies in AMR, supporting the potential of felzartamab to address critical gaps in transplant care and other kidney diseases,” said Daniel Quirk, MD, Chief Medical Officer at Biogen. “Biogen’s current research now spans seven different kidney diseases, and we’re proud to share updates on our portfolio’s progress with the nephrology community at this premier scientific congress.”

Biogen will also be hosting two exhibitor spotlights and 9 poster presentations related to both EMPAVELI and felzartamab. Felzartamab is currently being studied in three Phase 3 trials, TRANSCEND (NCT06685757) for AMR in adult kidney transplant recipients, PREVAIL (NCT06935357) in IgA nephropathy, and PROMINENT (NCT06962800) in primary membranous nephropathy, and a Phase 2 trial in microvascular inflammation (NCT07219043). Data from the TRANSCEND study is expected in H1 2027.

American Society of Nephrology Congress presentations include:

Oral Presentation: “Pegcetacoplan for 76 weeks maintains proteinuria reduction and eGFR stabilization for pediatric patients: VALIANT+VALE subgroup analysis,” on Thursday, October 22 at 4:30 PM MDT.Exhibitor Spotlight: “Beyond B Cells: Pioneering Plasmablast and Plasma Cell Targeting in Immunoglobulin A Nephropathy and Primary Membranous Nephropathy,” on Friday, October 23 at 12:00 PM MDT.Exhibitor Spotlight: A Treatment for Two Glomerular Diseases: C3G and Primary IC-MPGN on Friday, October 23 at 1:00 PM MDT.Oral Presentation: “Pegcetacoplan for 76 weeks maintained proteinuria reduction and stabilized kidney function in C3G or primary IC-MPGN,” on Saturday, October 24 at 4:30 PM MDT.Poster Presentations: “TRANSTELLAR: An Open-Label, Long-Term Extension Study of Felzartamab in Participants With Antibody-Mediated Rejection or Microvascular Inflammation,” on Thursday, October 22 at 10:00 AM MDT.“Epidemiology of Focal Segmental Glomerulosclerosis: A Systematic Review of Studies Published From 2020 to 2025,” on Friday, October 23 at 10:00 AM MDT.“Humanistic Burden of Focal Segmental Glomerulosclerosis: Findings From a Systematic Review,” on Friday, October 23 at 10:00 AM MDT.“Nephrologist Perceptions of Unmet Needs in the Treatment of Antibody-Mediated Rejection: Results From a Real-World Survey in Germany and the United States,” on Friday, October 23 at 10:00 AM MDT.“Effect of Current Antibody-Mediated Rejection (AMR) Treatments on Microvascular Inflammation (MVI) in Kidney Transplant Recipients: A Rapid Literature Review (RLR) and Meta-Analysis," on Friday, October 23 at 10:00 AM MDT.“Evaluation of Pegcetacoplan in Adults and Adolescents With Focal Segmental Glomerulosclerosis: Rationale and Design of a Sequential Phase 2/3 Study,” on Saturday, October 24 at 10:00 AM MDT.“User Experience With Pegcetacoplan On-Body Injector in Patients With C3G or Primary IC-MPGN,” on Saturday, October 24 at 10:00 AM MDT.“A Phase 2, Open-Label Trial to Examine Kidney Tissue–Specific Effects of Felzartamab in Adults With IgAN,” on Saturday, October 24 at 10:00 AM MDT.“Pharmacokinetic (PK), Pharmacodynamic (PD) and Exposure–Response (E–R) Analysis of Pegcetacoplan in C3 Glomerulopathy (C3G) & Primary Immune-Complex Membranoproliferative Glomerulonephritis (pIC-MPGN),” on Saturday, October 24 at 10:00 AM MDT. About EMPAVELI® (pegcetacoplan)
EMPAVELI® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can contribute to the onset and progression of serious diseases.

EMPAVELI is indicated in the United States for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function. EMPAVELI is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.1-3 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.4

About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on plasma cells, plasmablasts, and natural killer, or NK, cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Biogen owns exclusive worldwide rights to felzartamab.

Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.

U.S. Important Safety Information for EMPAVELI

BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.

CONTRAINDICATIONS

Hypersensitivity to pegcetacoplan or to any of the excipientsFor initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated Bacteria
EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.

Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.

Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.

EMPAVELI is available only through a restricted program under a REMS.

EMPAVELI REMS
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:

Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.

Further information is available at www.empavelirems.com or 1-888-343-7073.

Infusion-Related Reactions
Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.

Interference with Laboratory Tests
There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.

ADVERSE REACTIONS
Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence ≥10%) were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.

USE IN SPECIFIC POPULATIONS

Females of Reproductive Potential
EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.

Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide.

About the Sobi® and Apellis (now part of Biogen) Collaboration
Apellis (now part of Biogen) and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan. Apellis (now part of Biogen) has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, relating to, among others, the potential clinical effects of EMPAVELI and felzartamab; the potential benefits, safety and efficacy of EMPAVELI in patients with C3G or Primary IC-MPGN and of felzartamab in late antibody-mediated rejection in adult kidney transplant recipients, and in patients with IgAN, primary membranous nephropathy, and microvascular inflammation; the clinical development programs for EMPAVELI and felzartamab; advancing our anti-CD38 platform and our nephrology research and development programs; the potential of our commercial business and pipeline programs, including EMPAVELI and felzartamab; potential of, and expectations for the design, timing and results of our clinical trial programs, including the long-term EMPAVELI Phase 3 results, as well as the TRANSCEND, PREVAIL and PROMINENT studies; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References:

Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.Servais A, et al. Kidney Int. 2012;82(4):454-464.Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015.

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Biogen Inc (NASDAQ:BIIB, XETRA:IDP) is expected to report a slight third-quarter earnings per share beat at $2.14, against a consensus of $2.07, when it reports on October 28, says Jefferies.

Revenue should be in line at $2.6 billion, with lower cost of goods sold and research and development expenses partly offset by higher selling, general and administrative costs.

Management may reiterate or raise the low end of its 2026 revenue guidance, which implies growth of 3% to 7%, or $10.19 billion to $10.58 billion, against a consensus of $10.45 billion.

Guidance for non-GAAP earnings per share, which excludes certain items, is $12.00 to $13.00, against a consensus of $12.42.

Biogen is expected to report two Phase III datasets for litifilimab, an antibody for systemic lupus erythematosus (SLE), together in the fourth quarter.

Jefferies puts the chance that efficacy looks competitive at 60% to 65% and expects a share price move of 5% to 15%.

The bank wants a placebo-adjusted benefit in the low 20%s on the 52-week primary endpoint, against 26% in Phase II and 6% to 23% for Saphnelo, Benlysta and Gazyva, which awaits a December regulatory decision.

Even a high-teens statistically significant result could differentiate the drug, given its novel mechanism and monthly at-home injection, and Biogen enriched the trials for patients with active lupus arthritis, who respond particularly well.

Biogen could consider filing for approval even if only one of the two studies is positive, with Saphnelo as a regulatory precedent.

Approval of subcutaneous induction dosing for Leqembi, the Alzheimer's drug, for full at-home use could accelerate sales in 2027 as payer access eases.

Jefferies said further share price gains depend on positive data, since peak sales above $1 billion per indication could speed growth of Biogen's $10 billion base business.

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Continued improvement: An increased response was seen in participants on litifilimab from week 24 through week 52, with more individuals achieving clear or almost clear skin (27.2%; CLA IGA 0-1) and improvements in disease activity (28.8%; CLASI-70) than at week 24 (19.0% and 21.7%, respectively)Rapid onset: Participants that switched from placebo to litifilimab experienced improvements in skin disease activity in as early as four weeks -- consistent with results seen in participants who started on litifilimab reported earlier this yearConsistent safety: Litifilimab's safety profile remained consistent with previous studies, with no new safety signals identifiedResults from the Phase 3 part of AMETHYST are expected in the first half of 2027; in January 2026 the FDA granted Breakthrough Therapy Designation to litifilimab in CLE CAMBRIDGE, Mass., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced 52-week results from the Phase 2 part of the ongoing AMETHYST Phase 2/3 study (Part A) of litifilimab in people living with cutaneous lupus erythematosus (CLE). The updated results, presented at the European Academy of Dermatology and Venereology (EADV) 2026 Congress in Vienna, Austria, represent the longest dataset reported for litifilimab in CLE and further support its potential to achieve rapid and durable improvements in skin disease activity. In the study, participants treated with litifilimab in the double-blind, placebo-controlled period showed continued clinical improvements in skin disease activity through Week 52. Notably, participants who switched from placebo to litifilimab treatment at Week 24 experienced a rapid onset of treatment effect as early as four weeks.  

“Access to 52-week data is critical when evaluating a treatment for a lifelong, chronic disease like cutaneous lupus erythematosus, which can cause permanent scarring and disfigurement that many patients will carry with them forever. That is why achieving clear or almost clear skin, which is rarely seen in CLE, is a truly transformative treatment goal for this disease,” said Joseph F Merola, MD, MMSc, dermatologist, rheumatologist and President of the Rheumatologic Dermatology Society, Lupus Foundation Medical and Scientific Board. “It is highly encouraging to see continued improvement in skin clearance with litifilimab treatment – with over a quarter of participants reaching clear or almost clear skin – and data supporting litifilimab's long-term safety profile.”

Litifilimab is being evaluated as a potential once-monthly, first-in-class treatment designed to reduce inflammation at its source by selectively targeting blood dendritic cell antigen 2 (BDCA2) receptors on plasmacytoid dendritic cells (pDCs), which play a central role early in the inflammatory process in CLE. In January 2026, litifilimab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of CLE. 

The Phase 2 portion of the ongoing Phase 2/3 AMETHYST study evaluated 93 adults with active skin symptoms for whom standard antimalarial medications were not effective or not tolerable. Over the course of a full year, the study tracked key measures of skin redness, scaling and disease activity to assess how well litifilimab helped participants achieve healthier skin. By Week 52, more than a quarter (27.2%) of participants who received litifilimab from the beginning of the study achieved the clinical endpoint of clear or almost clear skin, as measured by a Cutaneous Lupus Activity Investigators' Global Assessment Revised (CLA-IGA-R) erythema score of 0 or 1, up from 19.0% at Week 24. Similar improvements were seen on the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-70 (CLASI-70) measurement with 28.8% of participants receiving litifilimab from the beginning of the study achieving a 70% or greater reduction in CLASI A at Week 52, compared to 21.7% at Week 24. For participants who started the study on placebo and transitioned to litifilimab halfway through the study, the onset of benefit was rapid – as early as four weeks – when skin symptoms began to improve. By Week 52, approximately one in three (33.7%) of these crossover participants reported clear or almost clear skin.

“Living with cutaneous lupus erythematosus carries a heavy physical toll, including dyspigmentation, pain, and scarring, which can be associated with comorbidities like depression and anxiety that can have a profound impact on daily life. These 52-week data reinforce litifilimab's potential to deliver rapid improvement and demonstrate its durable skin clearance effects,” said Daniel Quirk, M.D., Chief Medical Officer at Biogen. “We are encouraged by these results that build on findings in earlier studies as we anticipate the upcoming Phase 3 study results that reflect our commitment to advancing targeted therapies for serious autoimmune conditions.”

Over the course of the 52-week treatment period, litifilimab was generally well tolerated with a safety profile consistent with previously reported Phase 2 studies and no new safety signals identified. The majority of adverse events (AEs) reported were mild or moderate in severity, and serious AEs occurred in 3.4% (3/88) of participants during the extended treatment period. The most common AEs (≥5% during the extended treatment period) were nasopharyngitis, influenza and arthralgia.  

“People living with cutaneous lupus erythematosus face debilitating symptoms, including scarring, hair loss, and extreme sensitivity to light, yet they have long relied on treatments not specifically developed or studied for CLE,” said Albert T Roy, President and CEO of the Lupus Research Alliance. “The new data on litifilimab are encouraging because they point to the potential for both rapid symptom relief and durable improvement for people living with this condition. We look forward to seeing additional data from the Phase 3 study.”

About AMETHYST

AMETHYST is a two-part, Phase 2/3 multicenter, double-blind, placebo controlled, randomized study to evaluate the efficacy and safety of litifilimab compared to placebo. The study aims to assess the efficacy of litifilimab in participants with active subacute cutaneous lupus erythematosus (SCLE) and/or chronic cutaneous lupus erythematosus (CCLE) who are refractory or intolerant to antimalarial therapy. The Phase 2 and Phase 3 parts of the study are each 52 weeks in duration. Participants will be randomized to receive subcutaneous treatment with litifilimab or placebo every four weeks for 20 weeks with an additional dose at Week 2. All participants will receive litifilimab during the 28-week extended treatment period from Weeks 24 to 48. The Phase 3 part of the AMETHYST study remains blinded and is expected to read out in the first half of 2027. More information on the AMETHYST study (NCT05531565) is available at clinicaltrials.gov.

About Litifilimab (BIIB059)

Litifilimab (known as BIIB059) is an investigational first-in-class monoclonal antibody that is the first potential treatment developed by Biogen for lupus and is being evaluated in patients with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Its targeted mechanism of action acts early in the disease pathway to address the immune dysregulation that drives lupus. Litifilimab selectively targets BDCA2 receptors on plasmacytoid dendritic cells (pDCs) to reduce inflammation. Biogen developed litifilimab over two decades as part of a dedicated lupus discovery and development program.

Litifilimab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority, and its safety and effectiveness have not been established.

Positive results from the CLE portion of the two-part Phase 2 LILAC study were previously published in The New England Journal of Medicine (NEJM) showing litifilimab met the study's primary endpoint by demonstrating superior efficacy to placebo in reducing skin disease activity. In LILAC, litifilimab was generally well tolerated. The AMETHYST (NCT05531565) Phase 3 trial of litifilimab in CLE is currently ongoing.

About Cutaneous Lupus Erythematosus (CLE)

CLE, a type of lupus, is a serious autoimmune skin disease that impacts the daily lives of patients, including their emotional and mental health. It can lead to disfigurement in the form of hair loss, permanent scarring and abnormal skin color. In CLE, the immune system attacks healthy skin, causing rashes, pain, itching and sensitivity to sunlight. Currently, there are no approved targeted therapies for CLE and the last drug was approved in the 1950s.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor

This news release contains forward-looking statements relating to, among others, the potential clinical effects of litifilimab; the potential of litifilimab to make a clinically meaningful improvement for patients living with cutaneous lupus erythematosus (CLE); the potential benefits, safety and efficacy of litifilimab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected timing of trial results; the anticipation of Phase 3 trial results; the potential of Biogen's commercial business and pipeline programs, including litifilimab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SECÕs Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and this social media channel in addition to our press releases, SEC filings, public conference calls and webcasts, as the information posted on them could be material to investors.

Biogen Inc. (NASDAQ:BIIB – Get Free Report) shares hit a new 52-week high on Monday. The company traded as high as $229.62 and last traded at $228.8480, with a volume of 297708 shares. The stock had previously closed at $227.60.

Analyst Upgrades and Downgrades Several analysts have issued reports on BIIB shares. Zacks Research upgraded Biogen from a “strong sell” rating to a “hold” rating in a report on Tuesday, July 28th. Jefferies Financial Group reissued a “buy” rating on shares of Biogen in a research report on Monday, July 13th. Bank of America cut their price target on shares of Biogen from $217.00 to $215.00 and set a “neutral” rating on the stock in a report on Tuesday, July 21st. Canaccord Genuity Group upped their price target on shares of Biogen from $245.00 to $248.00 and gave the company a “buy” rating in a research report on Thursday, July 30th. Finally, Cantor Fitzgerald reaffirmed an “overweight” rating on shares of Biogen in a research note on Monday, June 22nd. One research analyst has rated the stock with a Strong Buy rating, seventeen have issued a Buy rating, thirteen have assigned a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat.com, the stock presently has a consensus rating of “Moderate Buy” and an average target price of $230.14.

Read Our Latest Stock Report on Biogen

Biogen Trading Down 0.7% The business has a 50-day moving average of $214.31 and a 200-day moving average of $200.17. The company has a quick ratio of 1.26, a current ratio of 1.87 and a debt-to-equity ratio of 0.39. The stock has a market cap of $33.55 billion, a price-to-earnings ratio of 40.19, a PEG ratio of 2.53 and a beta of 0.17. Biogen (NASDAQ:BIIB – Get Free Report) last issued its earnings results on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, topping the consensus estimate of $2.94 by $0.66. The company had revenue of $2.74 billion for the quarter, compared to analyst estimates of $2.46 billion. Biogen had a return on equity of 11.18% and a net margin of 8.32%.The business’s revenue was up 3.4% compared to the same quarter last year. During the same period in the prior year, the firm posted $5.47 EPS. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. As a group, research analysts forecast that Biogen Inc. will post 12.41 earnings per share for the current year.

Institutional Trading of Biogen A number of institutional investors have recently added to or reduced their stakes in BIIB. BlackRock Inc. acquired a new stake in shares of Biogen in the second quarter valued at about $3,453,878,000. Orbimed Advisors LLC acquired a new position in shares of Biogen during the 1st quarter worth about $11,293,000. Contrarius Group Holdings Ltd acquired a new position in shares of Biogen during the 4th quarter worth about $11,431,000. Nippon Life Global Investors Americas Inc. bought a new stake in Biogen during the 2nd quarter valued at approximately $29,648,000. Finally, Sector Gamma AS boosted its stake in Biogen by 13.2% during the 4th quarter. Sector Gamma AS now owns 85,475 shares of the biotechnology company’s stock valued at $15,043,000 after purchasing an additional 10,000 shares during the period. 87.93% of the stock is currently owned by institutional investors and hedge funds.

Biogen Company Profile (Get Free Report)

Biogen Inc is a biotechnology company that discovers, develops and commercializes therapies for serious neurological and neurodegenerative diseases. Its research focuses on conditions including multiple sclerosis, spinal muscular atrophy, Alzheimer’s disease, amyotrophic lateral sclerosis and rare neuromuscular disorders.

Biogen’s products include Spinraza (nusinersen) for spinal muscular atrophy, Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) for multiple sclerosis, Qalsody (tofersen) for a genetically defined form of ALS, and Skyclarys (omaveloxolone) for Friedreich’s ataxia.

Further Reading Five stocks we like better than Biogen CarMax Just Gave Investors a Better Reason to Believe in the Turnaround CoreWeave Comes With Risks: Analysts Split on What Matters Most Bottlenecking the Future: TSMC Prices Out the Competition Fervo Energy Hits Geothermal Milestone: Will It Matter For The Stock? Receive News & Ratings for Biogen Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Biogen and related companies with MarketBeat.com's FREE daily email newsletter.

Biogen (NASDAQ:BIIB – Get Free Report) and Mesoblast (NASDAQ:MESO – Get Free Report) are both healthcare companies, but which is the better business? We will compare the two businesses based on the strength of their risk, analyst recommendations, dividends, institutional ownership, profitability, valuation and earnings.

Insider and Institutional Ownership 87.9% of Biogen shares are held by institutional investors. Comparatively, 1.4% of Mesoblast shares are held by institutional investors. 0.3% of Biogen shares are held by company insiders. Comparatively, 18.8% of Mesoblast shares are held by company insiders. Strong institutional ownership is an indication that hedge funds, large money managers and endowments believe a company will outperform the market over the long term.

Risk & Volatility Biogen has a beta of 0.17, indicating that its share price is 83% less volatile than the S&P 500. Comparatively, Mesoblast has a beta of 2.12, indicating that its share price is 112% more volatile than the S&P 500.

Valuation & Earnings This table compares Biogen and Mesoblast”s revenue, earnings per share (EPS) and valuation. Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Biogen $9.89 billion 3.27 $1.29 billion $5.65 38.77 Mesoblast $120.25 million 16.06 -$57.50 million ($0.28) -53.11 Biogen has higher revenue and earnings than Mesoblast. Mesoblast is trading at a lower price-to-earnings ratio than Biogen, indicating that it is currently the more affordable of the two stocks.

Profitability This table compares Biogen and Mesoblast’s net margins, return on equity and return on assets.

Net Margins Return on Equity Return on Assets Biogen 8.32% 11.18% 6.88% Mesoblast N/A N/A N/A Analyst Ratings This is a breakdown of recent recommendations and price targets for Biogen and Mesoblast, as reported by MarketBeat.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Biogen 1 13 18 1 2.58 Mesoblast 1 0 1 0 2.00 Biogen presently has a consensus price target of $230.14, suggesting a potential upside of 5.06%. Mesoblast has a consensus price target of $39.00, suggesting a potential upside of 162.27%. Given Mesoblast’s higher probable upside, analysts clearly believe Mesoblast is more favorable than Biogen.

Summary Biogen beats Mesoblast on 11 of the 15 factors compared between the two stocks.

About Biogen (Get Free Report)

Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases in the United States, Europe, Germany, Asia, and internationally. The company provides TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for multiple sclerosis (MS); SPINRAZA for spinal muscular atrophy; ADUHELM to treat Alzheimer’s disease; FUMADERM to treat plaque psoriasis; BENEPALI, an etanercept biosimilar referencing ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS. It offers RITUXAN for treating non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin’s lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; OCREVUS for relapsing MS and primary progressive MS; LUNSUMIO to treat relapsed or refractory follicular lymphoma; glofitamab for non-Hodgkin’s lymphoma; and other anti-CD20 therapies. In addition, the company is developing various products for the treatment of MS, Alzheimer’s disease and dementia, neuromuscular disorders, Parkinson’s disease and movement disorders, neuropsychiatry, genetic neurodevelopmental disorders, and biosimilars, which are under various stages of development. It has collaboration and license agreements with Acorda Therapeutics, Inc.; Alkermes Pharma Ireland Limited; Denali Therapeutics Inc.; Eisai Co., Ltd.; Genentech, Inc.; Neurimmune SubOne AG; Ionis Pharmaceuticals, Inc.; Samsung Bioepis Co., Ltd.; Sangamo Therapeutics, Inc.; and Sage Therapeutics, Inc., as well as collaboration with Fujirebio to potentially identify and develop blood-based biomarkers for tau pathology in the brain. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.

About Mesoblast (Get Free Report)

Mesoblast Limited engages in the development of regenerative medicine products in Australia, the United States, Singapore, and Switzerland. The company offers products in the areas of cardiovascular, spine orthopedic disorder, oncology, hematology, and immune-mediated and inflammatory diseases. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage cells. The company offers Remestemcel-L that is in Phase III clinical trials for the treatment of systemic inflammatory diseases, including steroid refractory acute graft versus host disease, acute respiratory distress syndrome, and biologic refractory inflammatory bowel disease; and Remestemcel-L, which is in Phase III clinical trials to treat chronic heart failure and chronic low back pain due to degenerative disc disease. It is also developing MPC-300-IV to treat biologic refractory rheumatoid arthritis diabetic nephropathy; and MPC-25-IC for the treatment or prevention of acute myocardial infarction. It has strategic partnerships with Tasly Pharmaceutical Group to offer MPC-150-IM for heart failure and MPC-25-IC for heart attacks in China; JCR Pharmaceuticals Co. Ltd. to treat wound healing in patients with epidermolysis bullosa; and Grünenthal to develops and commercializes cell therapy for the treatment of chronic low back pain. The company was incorporated in 2004 and is headquartered in Melbourne, Australia.

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Corient Private Wealth LP raised its stake in shares of Biogen Inc. (NASDAQ:BIIB – Free Report) by 14.7% during the 2nd quarter, according to its most recent filing with the SEC. The firm owned 42,397 shares of the biotechnology company’s stock after acquiring an additional 5,445 shares during the period. Corient Private Wealth LP’s holdings in Biogen were worth $9,160,000 as of its most recent SEC filing.

Other institutional investors have also recently made changes to their positions in the company. Rothschild Investment LLC boosted its holdings in Biogen by 12.3% in the fourth quarter. Rothschild Investment LLC now owns 513 shares of the biotechnology company’s stock worth $90,000 after purchasing an additional 56 shares during the last quarter. Wedbush Securities Inc. boosted its stake in shares of Biogen by 5.1% in the 2nd quarter. Wedbush Securities Inc. now owns 1,164 shares of the biotechnology company’s stock worth $251,000 after buying an additional 56 shares during the last quarter. Meeder Advisory Services Inc. boosted its stake in shares of Biogen by 1.2% in the 1st quarter. Meeder Advisory Services Inc. now owns 4,721 shares of the biotechnology company’s stock worth $866,000 after buying an additional 57 shares during the last quarter. Kera Capital Partners Inc. grew its holdings in shares of Biogen by 3.5% in the first quarter. Kera Capital Partners Inc. now owns 1,723 shares of the biotechnology company’s stock worth $316,000 after acquiring an additional 58 shares during the period. Finally, Parallel Advisors LLC increased its position in Biogen by 1.5% during the first quarter. Parallel Advisors LLC now owns 4,367 shares of the biotechnology company’s stock valued at $801,000 after acquiring an additional 65 shares during the last quarter. Hedge funds and other institutional investors own 87.93% of the company’s stock.

Analyst Upgrades and Downgrades Several research analysts have issued reports on the company. Oppenheimer reissued an “outperform” rating and issued a $300.00 target price on shares of Biogen in a research report on Wednesday, July 29th. Wolfe Research upgraded shares of Biogen from a “peer perform” rating to an “outperform” rating and set a $300.00 price objective on the stock in a research note on Thursday, August 13th. Piper Sandler reissued an “overweight” rating and issued a $245.00 price objective (up from $225.00) on shares of Biogen in a report on Thursday, September 3rd. Stifel Nicolaus set a $242.00 target price on shares of Biogen in a research report on Thursday, September 10th. Finally, Morgan Stanley upped their target price on shares of Biogen from $222.00 to $231.00 and gave the company an “equal weight” rating in a report on Thursday, July 30th. One equities research analyst has rated the stock with a Strong Buy rating, eighteen have assigned a Buy rating, thirteen have given a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat.com, the company has an average rating of “Moderate Buy” and a consensus target price of $230.14.

Read Our Latest Report on BIIB Biogen Stock Down 0.1% Shares of BIIB stock opened at $216.01 on Thursday. The company has a market capitalization of $31.92 billion, a price-to-earnings ratio of 38.23, a PEG ratio of 2.39 and a beta of 0.17. Biogen Inc. has a one year low of $135.39 and a one year high of $225.80. The company’s fifty day moving average price is $210.27 and its 200-day moving average price is $197.90. The company has a debt-to-equity ratio of 0.39, a current ratio of 1.87 and a quick ratio of 1.26.

Biogen (NASDAQ:BIIB – Get Free Report) last issued its earnings results on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, topping the consensus estimate of $2.94 by $0.66. Biogen had a net margin of 8.32% and a return on equity of 11.18%. The company had revenue of $2.74 billion during the quarter, compared to the consensus estimate of $2.46 billion. During the same quarter in the prior year, the firm posted $5.47 EPS. Biogen’s quarterly revenue was up 3.4% compared to the same quarter last year. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. Sell-side analysts expect that Biogen Inc. will post 12.41 EPS for the current fiscal year.

Biogen Profile (Free Report)

Biogen Inc is a biotechnology company focused on discovering, developing and commercializing therapies for neurological and neurodegenerative diseases. Founded in 1978, the company is headquartered in Cambridge, Massachusetts, and serves patients and healthcare providers in markets around the world.

Biogen’s portfolio includes treatments for multiple sclerosis, including Tecfidera, Vumerity, Tysabri, Avonex and Plegridy, as well as Spinraza for spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.

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MarketBeat Week in Review – 05/18 - 05/22Biogen NASDAQ: BIIB is reshaping its business around a broader mix of neuroscience, immunology, kidney disease and ophthalmology assets, President and CEO Chris Viehbacher said during a Morgan Stanley event. The company expects a series of late-stage clinical readouts to begin as soon as next quarter and said its recently acquired assets could help accelerate revenue growth.

Viehbacher said the company’s prior strategy was concentrated in neuroscience, with expensive late-stage programs and a narrow commercial footprint focused on neurologists. Biogen now calls on a wider range of specialists, including nephrologists, transplant nephrologists, rheumatologists, dermatologists, epileptologists and retina specialists.

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Biogen Stock Slides After Trial Miss, But Analysts Stay Bullish“Internally, we talk about new Biogen,” Viehbacher said, describing the company’s effort to retain its neuroscience roots while expanding into immunology and other areas with potentially shorter, more defined Phase II studies.

Pipeline and business development strategy Biogen’s business-development activity has included the acquisition of Human Immunology Biosciences, or Hi-Bio, which added felzartamab, and the acquisition of Apellis Pharmaceuticals. Viehbacher said both transactions fit the company’s focus on immunology, including rare and smaller indications.

3 Biotech Stocks That Look Like “Sure-Fire” Winners in 2026He said Biogen has 10 Phase III trials that are expected to start producing results as soon as the next quarter. Those trials could support eight product launches or new indications involving five molecules, according to Viehbacher.

Looking ahead, Biogen intends to focus capital deployment on earlier-stage opportunities, including preclinical, Phase I and Phase II assets. Viehbacher said early development is also the most capital-efficient stage for acquisitions, although competition remains high in immunology because disease biology is well defined in some areas. He added that the pool of early-stage assets has expanded with the emergence of China-based drug development.

LEQEMBI access and Alzheimer’s development Viehbacher said Alzheimer’s treatment uptake for LEQEMBI has been slower than some expected despite substantial unmet need. He attributed the pace in part to operational changes required at neurology practices, including arranging PET scans, MRIs, cognitive assessments, infusion capacity and supporting staff.

Biogen and partner Eisai are working to simplify the treatment pathway, he said. Blood-based diagnostics may reduce reliance on PET scans, which Viehbacher said can cost about $5,000, compared with less than $130 for a blood-based diagnostic. The company has also seen the proportion of eligible patients among those referred improve from 50% to 70% as blood-based testing is increasingly used in primary care settings, he said.

Biogen received approval for a subcutaneous LEQEMBI maintenance formulation last year and an induction formulation this year. Viehbacher said the induction approval could improve the treatment pathway and competitive positioning, but broad uptake depends on Medicare Part D reimbursement.

He said negotiations with plans are under way, with reimbursement decisions effective Jan. 1. More than 80% of requested medical formulary exceptions have been approved, he added.

Biogen’s AHEAD 3-45 study of LEQEMBI in earlier-stage Alzheimer’s disease is fully enrolled and is expected to read out in 2028 after four years of follow-up. Viehbacher said the studies are designed to assess whether earlier intervention against amyloid accumulation can delay or prevent disease progression. Biogen is also advancing diranersen, a tau-targeting program.

Lupus and kidney disease readouts ahead Biogen expects Phase III data in systemic lupus erythematosus, or SLE, for litifilimab in the fourth quarter. A Phase III study in cutaneous lupus erythematosus, or CLE, is expected to generate data in the first half of 2027, while the company expects one-year CLE data at a European conference later this year.

Viehbacher acknowledged the challenges of SLE trials, citing disease heterogeneity, varying symptoms, flare-and-remission patterns and background steroid use. Still, he said Biogen has applied lessons from previous lupus studies and believes its experience in multiple sclerosis could be commercially relevant.

The company estimates the worldwide lupus market at about $8 billion, although Viehbacher said broader biologic penetration could take time. Biogen is also partnered with UCB on dapirolizumab, which has produced one positive Phase III result, and has an IRAK4 degrader that has entered the clinic.

Felzartamab is being studied initially across four kidney indications: antibody-mediated rejection, or AMR; immunoglobulin A nephropathy, or IgAN; primary membranous nephropathy; and microvascular inflammation. Data in AMR are expected in the first half of next year.

Viehbacher said a Phase II study showed an 80% resolution rate in AMR, though he cautioned that the result must be replicated in Phase III. He said the U.S. AMR patient population is about 11,000 people and that Biogen could be first to market if the program succeeds.

For IgAN, he highlighted the potential for a treatment-free period after nine infusions. Biogen observed an effect maintained for 18 months without treatment in earlier data, he said, though the duration will be tested in Phase III studies.

Apellis products support commercial expansion Viehbacher said Apellis added growth products SYFOVRE and EMPAVELI while also giving Biogen a commercial nephrology presence ahead of a potential felzartamab launch.

He said SYFOVRE growth accelerated somewhat following the acquisition after Biogen retained the commercial team. Biogen had initially modeled mid-single-digit growth for the product, and Viehbacher said the company is now somewhat more optimistic than it was at the time of the acquisition, while noting the competitive environment.

EMPAVELI has enabled Biogen to build relationships with nephrologists and transplant centers, Viehbacher said. That existing infrastructure could support a faster uptake for felzartamab if the clinical data and eventual label support approval.

About Biogen (NASDAQ:BIIB)Biogen Inc is a biotechnology company focused on discovering, developing and commercializing therapies for neurological and neurodegenerative diseases. Founded in 1978, the company is headquartered in Cambridge, Massachusetts, and serves patients and healthcare providers in markets around the world.

Biogen's portfolio includes treatments for multiple sclerosis, including Tecfidera, Vumerity, Tysabri, Avonex and Plegridy, as well as Spinraza for spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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MarketBeat Week in Review – 05/18 - 05/22Biogen NASDAQ: BIIB executives said the company is focused on diversifying beyond its historical neurology concentration, advancing a broader late-stage pipeline and managing expenses as it seeks to return to growth.

Speaking at a Wells Fargo conference, Chief Financial Officer Robin Kramer said Biogen has made progress launching growth products, offsetting erosion in its multiple sclerosis portfolio and reshaping its research pipeline. The company now has 10 Phase III programs, with readouts beginning in the fourth quarter, she said.

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Biogen Stock Slides After Trial Miss, But Analysts Stay Bullish“The pipeline is at a pivotal point for us from a growth perspective,” Kramer said. She added that Biogen is also working to control operating expenses while investing in product launches and pipeline development.

Portfolio diversification and capital allocation Kramer said Biogen’s Fit for Growth initiative was designed to optimize the company’s cost base and infrastructure while redirecting investment from its MS portfolio to newer launches, including LEQEMBI, SKYCLARYS and ZURZUVAE. The company also prioritized R&D programs where it had the highest conviction, she said.

3 Biotech Stocks That Look Like “Sure-Fire” Winners in 2026Adam Keeney, Biogen’s head of corporate development, said the company has intentionally looked for development opportunities with validated endpoints, clearer regulatory paths and more established Phase III trial designs. That approach differs from pursuing unvalidated biology across the portfolio, he said.

Biogen has expanded into immunology and nephrology through transactions including its acquisition of HI-Bio and its felzartamab asset. Keeney said felzartamab’s initial focus is antibody-mediated rejection, or AMR, in kidney transplantation.

According to Keeney, there are no approved therapies for AMR, and approximately 11,000 U.S. patients experience secondary rejection of their kidney transplants. He described AMR as the “foundational opportunity” for felzartamab, which Biogen also plans to evaluate in IgA nephropathy, membranous nephropathy and other potential indications.

Biogen has also initiated two undisclosed Phase II proof-of-concept studies involving CD38 in autoantibody-driven diseases outside nephrology, Keeney said.

Apellis acquisition and nephrology expansion The company said its acquisition of Apellis added commercial products and nephrology capabilities, including medical and commercial infrastructure that could support a future felzartamab launch. Kramer said Biogen expects the Apellis transaction to be dilutive in 2026, primarily because of interest expense.

Biogen has already implemented some cost actions, she said, and expects annualized savings of roughly $250 million exiting next year. Those savings are expected to come largely from research and development and general and administrative functions, while sales and medical organizations are being kept largely intact.

Keeney said Biogen sees significant opportunity in geographic atrophy, where Apellis’ SYFOVRE operates. He said the market remains underpenetrated and that growth will depend on bringing in new patients and maintaining persistence among patients already receiving treatment.

“New patient starts and persistency are critical,” Keeney said, adding that Biogen is considering direct-to-consumer and other awareness efforts around the need for early intervention and continued treatment.

MS, SMA and royalty considerations Kramer said TYSABRI has shown resilience following biosimilar entry, which she attributed to the product’s reputation among neurologists and patients, Biogen’s patient-services organization and its FDA-approved JCV assay. Outside the U.S., the company also offers a subcutaneous formulation of TYSABRI.

She said the company’s growth portfolio more than offset erosion in the legacy MS portfolio for most quarters in 2025. In the second quarter, growth products excluding the two Apellis products exceeded the legacy MS portfolio, according to Kramer.

Biogen also expects continued contributions from its relationship with Roche and Genentech. Kramer noted that Roche recently launched a subcutaneous version of OCREVUS, which has shown traction. Biogen receives royalties tied to OCREVUS and participates in profit-sharing arrangements involving RITUXAN and GAZYVA. GAZYVA received U.S. and European approvals for lupus nephritis this year, she said.

In spinal muscular atrophy, executives said SPINRAZA patient volumes have stabilized and that patients have transitioned rapidly from lower-dose treatment to the higher-dose option. Biogen also sees its acquired Alcyone device technology as a way to reduce administration barriers for certain patients receiving intrathecal therapies. The implanted device could allow SPINRAZA to be injected through a port rather than requiring a spinal tap for each quarterly administration, Keeney said.

Outlook for business development Looking ahead, Keeney said Biogen expects to focus more on earlier-stage business-development opportunities through 2027, particularly in immunology, rare disease and neurology. He said the company is not financially constrained for early-stage transactions and could consider larger transactions as its balance sheet builds next year.

Kramer said Biogen expects to pay down debt associated with the Apellis deal by the end of 2027. For the coming year, she said success would mean meeting growth portfolio commitments on revenue and earnings while preparing for potential launches in lupus and AMR.

About Biogen (NASDAQ:BIIB)Biogen Inc is a biotechnology company focused on discovering, developing and commercializing therapies for neurological and neurodegenerative diseases. Founded in 1978, the company is headquartered in Cambridge, Massachusetts, and serves patients and healthcare providers in markets around the world.

Biogen's portfolio includes treatments for multiple sclerosis, including Tecfidera, Vumerity, Tysabri, Avonex and Plegridy, as well as Spinraza for spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Biogen Inc. (BIIB) Presents at Wells Fargo 21st Annual Healthcare Conference Transcript

BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB) today announced presentations of data at the 16th European Epilepsy Congress (EEC), taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. Dravet.

–4-year data from the Phase 1/2a open-label extension (OLE) studies support the potential disease-modifying effects of zorevunersen–

–Improvements in cognition and behavior sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile–

–New data from sub-analyses of patients treated with zorevunersen in the Phase 1/2a OLEs include effects on severe seizures and quality of life–

BEDFORD, Mass. and CAMBRIDGE, Mass., Sept. 01, 2026 (GLOBE NEWSWIRE) -- Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB) today announced presentations of data at the 16th European Epilepsy Congress (EEC), taking place September 5–9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. The global, pivotal Phase 3 EMPEROR study is underway to evaluate the safety and efficacy of zorevunersen, and results are anticipated in the third quarter of 2027.

Data to be shared at EEC include the first medical meeting presentation of 4-year results from the ongoing Phase 1/2a open-label extension (OLE) studies of zorevunersen in patients with Dravet syndrome. Improvements in cognition and behavior were sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile. New exploratory sub-analyses show effects on the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy (SUDEP)1, as well as improvements in quality of life for patients treated with zorevunersen.

"Together with the Phase 1/2a results, the ongoing OLE studies provide more than 5 years of clinical data that continue to deepen our understanding of zorevunersen’s long-term safety and benefits,” said Barry Ticho, M.D., Ph.D., Chief Medical Officer of Stoke Therapeutics. “These data have consistently shown substantial and durable seizure reductions with continued treatment. For the first time at EEC, we will share an additional analysis showing zorevunersen’s effects on the most severe seizure types. Alongside continuing improvements in cognition and behavior over time, these new findings support the potential of zorevunersen to change the course of Dravet syndrome by targeting the underlying genetic cause of the disease.”

“Dravet syndrome is a devastating neurodevelopmental disease that impacts nearly every aspect of daily life for patients and those who care for them,” said Stephanie Fradette, Pharm.D., Head of the Rare Neurology Development Unit at Biogen. “The data shared at EEC provide continued support for the potential of zorevunersen to give people living with Dravet syndrome the possibility of more neurotypical development. We look forward to discussing these data with the epilepsy community at EEC.”

Details of the EEC presentations are as follows:

Title: Zorevunersen Demonstrates Disease-Modifying Potential in Patients with Dravet Syndrome with Improvements in Seizure Burden, Quality of Life, and Overall Clinical Status
Oral Presentation Date & Time: Sunday, September 6, 12:53-1:02 PM EEST/ UTC+3 (5:53-6:02 AM ET)Oral Presenter: J. Helen Cross, MB ChB, Ph.D., Professor, The Prince of Wales’s Chair of Childhood Epilepsy and Head of the Developmental Neuroscience Programme at University College London Great Ormond Street Institute of Child Health, Honorary Consultant in Paediatric Neurology and Past President of the International League Against Epilepsy Title: Zorevunersen Demonstrates Potential as a Disease-Modifying Therapy in Patients with Dravet Syndrome: A Matching-Adjusted Indirect Comparison Between Natural History and Patients Receiving Zorevunersen
Poster Presentation Date & Time: Monday, September 7, 2:00-3:00 PM EEST/ UTC+3 (7:00-8:00 AM ET)Poster Presenter: Andreas Brunklaus, MD, Consultant Paediatric Neurologist at the Royal Hospital for Children in Glasgow, Honorary Professor at the University of Glasgow
Poster Number: P0803 Title: Zorevunersen Demonstrates Potential as a Disease-Modifying Therapy in Patients with Dravet Syndrome Through Durable Seizure Reduction and Improvements in Cognition, Behavior, and Quality of Life Through 48 Months of Treatment in Open-Label Extension Studies
Poster Presentation Date & Time: Tuesday, September 8, 2:00-3:00 PM EEST/ UTC+3 (7:00-8:00 AM ET)Poster Presenter: Elaine Wirrell​, MD, Director of Pediatric Epilepsy at Mayo Clinic, Director of the Child and Adolescent Neurology Residency Training Program at Mayo Clinic
Poster Number: P0797 Summary of Zorevunersen Safety Data

Following treatment in the Phase 1/2a studies, 93% (75/81) patients continued treatment in one of two OLE studies. As of the 4-year data cutoff, 77% (58/75) patients remained in these studies.Zorevunersen continues to be generally well tolerated, with some patients treated for more than 5 years in the Phase 1/2a and ongoing OLE studies. As of July 31, 2026, more than 930 doses have been administered.Elevated CSF protein lab values occurred in approximately 94% of patients of which 59% have been classified as a treatment-emergent adverse event. Importantly, no serious or severe clinical manifestations have been associated with CSF protein elevations. There have been no reports of hydrocephalus. About Dravet Syndrome
Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve ≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections 2. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan 3. There are no approved disease-modifying therapies for people living with Dravet syndrome.

About Zorevunersen
Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function in the SCN1A gene, and China’s Center for Drug Evaluation has granted zorevunersen Breakthrough Therapy Designation. Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Zorevunersen is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.

About the Phase 1/2a and Open-Label Extension Studies
Two Phase 1/2a open-label, multicenter studies evaluated the effects of zorevunersen in patients with highly refractory Dravet syndrome ages 2 to 18 years (N=81). Primary endpoints were the safety profile, plasma pharmacokinetics (PK) and exposure in cerebrospinal fluid (CSF) of single and multiple doses of zorevunersen. Secondary endpoints included percentage change from baseline in major motor seizure frequency, overall clinical status (a measure of patients’ overall functioning) and quality of life. The ADMIRAL Phase 1/2a study included an exploratory endpoint to evaluate changes in neurodevelopmental status (cognition & behavior) as measured by Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Phase 1/2a studies were completed in November 2023. Following treatment in the Phase 1/2a studies, eligible patients continued treatment with zorevunersen every four months in one of two OLEs. There was at least a 6-month gap between the last dose administered in the Phase 1/2a studies and the first dose administered in the OLEs. The primary endpoints are the safety profile of multiple doses of zorevunersen. Secondary endpoints include PK parameters, percentage change from baseline in major motor seizure frequency, change in overall clinical status, and change from baseline in quality of life. Exploratory endpoints include changes in neurodevelopment status as measured by Vineland-3. Results from the Phase 1/2a and OLE studies were published in The New England Journal of Medicine (NEJM) in March 2026. The OLE studies are ongoing.

About Stoke Therapeutics
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ or follow us on LinkedIn.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, Instagram, LinkedIn, X, YouTube.

Stoke Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the potential benefits, safety and efficacy of zorevunersen; the design, timing and expected progress of clinical trials, data readouts, regulatory meetings, regulatory decisions and other presentations; and the participation of scientists associated with Stoke making presentations at EEC and the presentation of data at EEC. Statements including words such as “plan,” “potential,” “will,” “continue,” “expect,” or similar words and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause Stoke’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: Stoke’s ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if Biogen were to breach or terminate the collaboration, Stoke would not obtain the anticipated financial or other benefits; the possibility that Stoke and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully commercialize zorevunersen; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; Stoke’s ability to protect its intellectual property; Stoke’s ability to fund development activities and achieve development goals into 2028; and the other risks and uncertainties described under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2025, its quarterly reports on Form 10-Q, and the other documents it files with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Stoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Biogen Safe Harbor
This news release contains forward-looking statements, including, among others, relating to: the potential clinical effects of zorevunersen; the potential for zorevunersen to change the course of Dravet syndrome and improve outcomes for patients; the expected timing of Phase 3 study results; the potential benefits, safety and efficacy of zorevunersen; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of the underlying causes of Dravet syndrome; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with Stoke Therapeutics; the potential of Biogen's commercial business and pipeline programs, including zorevunersen; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Biogen Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References:

Beniczky, S. et al. Updated classification of epileptic seizures: Position paper of the International League Against Epilepsy. Epilepsia. 2025; 1804–1823.Symonds, J. et al. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic determinants. Brain. 2021;144(9):2879-2891.Based on Stoke Therapeutics’ preliminary estimates, which scaled annual incidence to prevalence using country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by Wu et al., Pediatrics, 2015.

Canada Pension Plan Investment Board purchased a new position in shares of Biogen Inc. (NASDAQ:BIIB – Free Report) during the second quarter, according to its most recent disclosure with the Securities & Exchange Commission. The institutional investor purchased 13,602 shares of the biotechnology company’s stock, valued at approximately $2,939,000.

Several other hedge funds and other institutional investors have also recently made changes to their positions in BIIB. Empowered Funds LLC raised its stake in Biogen by 64.9% in the first quarter. Empowered Funds LLC now owns 7,054 shares of the biotechnology company’s stock valued at $965,000 after buying an additional 2,777 shares during the last quarter. Focus Partners Wealth grew its stake in shares of Biogen by 172.2% during the first quarter. Focus Partners Wealth now owns 10,173 shares of the biotechnology company’s stock worth $1,392,000 after acquiring an additional 6,436 shares during the last quarter. Sivia Capital Partners LLC acquired a new position in shares of Biogen during the second quarter valued at about $216,000. Cerity Partners LLC increased its holdings in shares of Biogen by 15.3% during the second quarter. Cerity Partners LLC now owns 46,552 shares of the biotechnology company’s stock valued at $5,847,000 after acquiring an additional 6,184 shares in the last quarter. Finally, NewEdge Advisors LLC raised its position in shares of Biogen by 13.4% in the 2nd quarter. NewEdge Advisors LLC now owns 2,673 shares of the biotechnology company’s stock valued at $336,000 after purchasing an additional 316 shares during the last quarter. Hedge funds and other institutional investors own 87.93% of the company’s stock.

Biogen Stock Performance NASDAQ BIIB opened at $218.50 on Monday. Biogen Inc. has a 1 year low of $131.52 and a 1 year high of $222.85. The company has a debt-to-equity ratio of 0.39, a current ratio of 1.87 and a quick ratio of 1.26. The company has a market capitalization of $32.28 billion, a PE ratio of 38.67, a P/E/G ratio of 6.81 and a beta of 0.17. The company has a fifty day moving average of $207.81 and a 200 day moving average of $195.69.

Biogen (NASDAQ:BIIB – Get Free Report) last released its quarterly earnings data on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, beating analysts’ consensus estimates of $2.94 by $0.66. The business had revenue of $2.74 billion during the quarter, compared to analyst estimates of $2.46 billion. Biogen had a return on equity of 11.18% and a net margin of 8.32%.The company’s revenue was up 3.4% on a year-over-year basis. During the same quarter last year, the business posted $5.47 EPS. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. Research analysts forecast that Biogen Inc. will post 12.39 earnings per share for the current year. Wall Street Analysts Forecast Growth A number of research firms recently commented on BIIB. UBS Group lifted their target price on shares of Biogen from $225.00 to $240.00 and gave the stock a “buy” rating in a research note on Thursday, July 30th. Piper Sandler restated an “overweight” rating on shares of Biogen in a research note on Tuesday, July 14th. Weiss Ratings cut shares of Biogen from a “hold (c)” rating to a “hold (c-)” rating in a report on Wednesday, August 12th. Evercore began coverage on shares of Biogen in a report on Friday, May 15th. They set an “outperform” rating on the stock. Finally, Oppenheimer reissued an “outperform” rating and issued a $300.00 target price on shares of Biogen in a research report on Wednesday, July 29th. One investment analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating, thirteen have assigned a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and an average price target of $227.79.

Get Our Latest Report on Biogen

Biogen Company Profile (Free Report)

Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer’s disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.

The company’s marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.

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Key Takeaways Eli Lilly and Roche's blood test is FDA-cleared to assess amyloid-beta pathology.Healthcare ETFs offer diversified exposure to companies advancing Alzheimer's diagnostics and therapies.ETFs like IXJ hold companies involved in the growing Alzheimer's market. In a significant development for Alzheimer's diagnostics, the U.S. Food and Drug Administration (FDA) has recently granted clearance to the Elecsys pTau217 blood test, developed jointly by healthcare giants Eli Lilly (LLY - Free Report) and Roche (RHHBY - Free Report) . The test is designed to identify amyloid-beta pathology in individuals aged 55 and older exhibiting signs of cognitive decline, supporting both rule-in and rule-out assessments in primary and specialty care settings.

Notably, it is the first and only FDA-cleared single-biomarker blood test to offer this dual capability using one validated clinical cutoff. 

This regulatory milestone comes against a backdrop of a mounting health crisis, with an estimated 7.4 million Americans aged 65 and older currently living with clinical Alzheimer's dementia, a figure projected to nearly double to 13.8 million by 2060 (as per NIH data). 

With the long-term national care costs for people living with dementia projected to reach $409 billion by the end of this year, the FDA's green light for a more accessible, blood-based diagnostic tool thrusts both Eli Lilly and Roche, and by extension the healthcare exchange-traded funds (ETFs) that hold significant positions in these pharmaceutical giants, into the global investment spotlight. 

But before identifying those particular ETFs, it is important to understand the commercial value of Alzheimer’s diagnostics and therapies and, ultimately, why sector-focused ETFs offer compelling portfolio exposure to this expanding market.

Booming Market for Alzheimer's TreatmentsThe economic landscape surrounding early detection and treatment of Alzheimer's represents one of the largest growth opportunities in modern biopharmaceuticals. To this end, it is imperative to mention that health and long-term care costs for American people living with dementia are projected to reach nearly $1 trillion in 2050.

With Alzheimer's disease being the leading cause of dementia, diagnostic tools like the Elecsys pTau217 getting regulatory approval should exponentially expand the eligible pool of patients for disease-modifying therapies (DMTs). Consequently, this should boost LLY and RHHBY’s revenue growth opportunities, with the global Alzheimer's DMT market projected to surge to $13.1 billion by the end of 2030 (as per BCC Research data). 

Recognizing the growth potential of the Alzheimer’s DMT market, Eli Lilly and Roche, along with other pharmaceutical giants, are also funneling significant capital into this space. For instance, AbbVie (ABBV - Free Report) completed its acquisition of Aliada Therapeutics in late 2024 for $1.4 billion, gaining access to ALIA-1758, an investigational anti-pyroglutamate amyloid beta antibody currently in Phase 1 trials. 

Biogen (BIIB - Free Report) is conducting advanced research to support earlier diagnosis through blood-based biomarkers and investigating therapies directed at key drivers of Alzheimer’s disease biology, including amyloid and tau. Its Lecanemab anti-amyloid antibody, co-developed with Eisai, has recently expanded to include at-home administration options via subcutaneous autoinjector formulations for early-stage Alzheimer's patients. 

Pharma giant Novartis (NVS - Free Report) is evaluating VHB937, a TREM2-targeting candidate currently in Phase 2 clinical trials for early Alzheimer's disease. The company has also entered into a massive licensing and collaboration agreement worth up to $1.7 billion with SciNeuro Pharmaceuticals to develop a next-generation, amyloid-beta-targeting antibody program.

Eli Lilly is independently conducting Phase 3 clinical trials for the efficacy of its donanemab in participants with preclinical Alzheimer's Disease. Notably, donanemab is an FDA-approved monoclonal antibody, designed to clear brain amyloid plaques in early symptomatic Alzheimer's patients. 

Why Healthcare ETFs Offer a Strategic Investment ApproachFor investors looking to gain exposure to the potential upside from the Alzheimer’s treatment market, healthcare ETFs present a compelling option. 

Investing directly in individual biotech or pharmaceutical equities carries inherent concentration risk, as clinical trials can produce mixed efficacy results, regulatory delays, or patent disputes.

Instead, by investing in a healthcare ETF that counts the aforementioned stocks among its top holdings, investors can position themselves to benefit from the collective progress these companies are making in Alzheimer's diagnostics and therapeutics.

Healthcare ETFs to TrackConsidering the aforementioned discussion, investors interested in capitalizing on the growth potential of Alzheimer’s treatment can add the following ETFs to their watchlist and invest once they seem fit:

State Street Health Care Select Sector SPDR ETF (XLV - Free Report)  

This fund, with assets under management (AUM) worth $44.57 billion, offers exposure to 60 companies in the pharmaceuticals; health care equipment and supplies; health care providers and services; biotechnology; life sciences tools and services; and health care technology industries. Of these, LLY holds the first spot with 15.43% weightage, while ABBV holds the third spot with 7.42% weightage. 

XLV has rallied 26.7% over the past year and charges 8 basis points (bps) in fees. 

iShares Global Healthcare ETF (IXJ - Free Report)

This fund, with net assets worth $4.38 billion, offers exposure to 110 pharmaceutical, biotech, and medical device companies worldwide. Of these, LLY holds the first spot with 10.33% weightage, while ABBV holds the third spot with 4.97% weightage. RHHBY holds the fifth position in this fund with 3.90% weightage, while NVS holds the seventh spot with 3.49% weightage. BIIB holds 0.39% of this fund’s assets. 

IXJ has gained 21.4% over the past year and charges 38 bps in fees. 

VanEck Pharmaceutical ETF (PPH - Free Report)

This fund, with net assets worth $1.06 billion, offers exposure to 26 companies involved in pharmaceuticals, including research and development, as well as the production, marketing and sale of pharmaceuticals. Of these, LLY holds the first spot with 19.32% weightage, while NVS holds the third spot with 10.07% weightage. ABBV holds the eighth position in this fund with 4.49% weightage. 

PPH has soared 30.4% over the past year and charges 36 bps in fees. 

iShares Neuroscience and Healthcare ETF (IBRN - Free Report)

This fund, with net assets worth $8 million, offers exposure to 68 global companies advancing research and treatment of neurological disorders. Of these, Praxis Precision Medicines holds the first spot with 5.31% weightage, while BIIB holds the ninth position with 4.14% weightage. 

IBRN has surged 60.6% over the past year and charges 47 bps in fees. 

LEQEMBI IQLIK is the first-of-its-kind anti-amyloid treatment worldwide offering at-home dosing
for initiation and maintenance (approved in the U.S.)

, /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that once weekly lecanemab‑irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) is now available in the U.S. for initiation therapy for early Alzheimer's disease (AD) in adults with mild cognitive impairment (MCI) or mild dementia due to AD, collectively referred to as early AD. MCI due to AD is the earliest symptomatic stage of AD and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.1 

LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two consecutive 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous (SC) treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as SC injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration.

Expanding Treatment Convenience and Flexibility Across the Alzheimer's Disease Care Pathway
The availability of LEQEMBI IQLIK for both initiation and maintenance therapy in the U.S. enhances treatment convenience and flexibility, offering early AD patients and their care partners more control in managing their care while lowering barriers to initiating and continuing treatment with LEQEMBI. LEQEMBI IQLIK may reduce the time spent receiving anti-amyloid therapy via IV infusions. In addition, at-home administration allows patients and their care partners to continue treatment without the burden of clinic visits, making it easier to go out and travel. LEQEMBI IQLIK also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring. These features may help streamline the overall AD treatment pathway. For ARIA monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation.

Support Resources for LEQEMBI IQLIK
Eisai and Biogen will provide a range of resources to help patients, care partners, healthcare providers, health systems and pharmacies successfully implement and use LEQEMBI IQLIK.

Patient Support
Resources include an Instructions for Use (IFU) video and IQLIK Welcome Kit. The IQLIK Welcome Kit provides a What to Expect Treatment Tracker, an injection reminder magnet, and a Demo Kit to help patients and care partners understand what to expect, prepare for at-home injections, and administer injections safely at home. The LEQEMBI Companion® app will also be available. It brings the information patients and care partners need into one experience, including education about the injection process and tools for tracking each dose.

Patients initiating IQLIK will be encouraged to bring the Welcome Kit to their initial dosing appointment. Kits will be available through: 

The LEQEMBI Specialty Pharmacy Network (CareMed Specialty Pharmacy and Walgreens Specialty Pharmacy)   Integrated Delivery Networks (IDNs) or the prescribing physician  LEQEMBI Companion® - a program offering financial support information and options for eligible patients.   Through the LEQEMBI Specialty Pharmacy Network, patients may receive support with prescription fulfillment, insurance coverage navigation, onboarding, delivery coordination, device-use education, and – if they choose to participate – treatment reminders and educational support during the first six months of therapy. Patients using other eligible specialty pharmacies may have access to similar support, which may vary by pharmacy.

Healthcare Provider Resources
Electronic Health Record (EHR) support materials and a step-by-step Getting Started Guide will help providers navigate the process from prescription submission through therapy initiation.

Financial Assistance
To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria.

*The LEQEMBI Companion app was developed to deliver behavior-driven digital support for patients and care partners along their treatment journey, in partnership with Medisafe Ltd., a behavioral patient engagement engine built for complex and specialty therapies. Patients can visit LEQEMBI.com/CompanionAppSignUp to get started.

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

INDICATION
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.

IMPORTANT SAFETY INFORMATION

WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)

•

Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.

•

Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.

•

Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.

CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS

AMYLOID-RELATED IMAGING ABNORMALITIES
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

Risk Factors of ARIA and ICH

ApoE ε4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.

Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.

Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.

Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.

HYPERSENSITIVITY REACTIONS

Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

INFUSION-RELATED REACTIONS (IRRs)

IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

ADVERSE REACTIONS

The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%) The safety profile of subcutaneous LEQEMBI was similar to intravenous infusion. Subcutaneous dosing was associated with mostly localized (erythema, induration, swelling, heat, pain, pruritus, rash, ecchymosis, nodule, and hematoma) and less frequent systemic (headache, chills, fever, and fatigue) injection-related reactions, majority at first dose when initiating therapy. Localized reactions that were recurrent and/or delayed were observed. Severe localized reactions and cases leading to dose discontinuation or interruption occurred. LEQEMBI (lecanemab-irmb) is available:

Intravenous infusion: 100 mg/mL Subcutaneous injection: 200 mg/mL Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

Click here to access the LEQEMBI digital library with assets available for download.

MEDIA CONTACTS

Eisai Co., Ltd.

Public Relations Department

TEL: +81 (0)3-3817-5120 

Biogen Inc.

Madeleine Shin

+1-781-464-3260

[email protected]  

Eisai Europe, Ltd.

EMEA Communications Department

+44 (0) 7760 619251

[email protected]

Eisai Inc. (U.S.)

Julie Edelman

+1-862-213-5915

[email protected] 

INVESTOR CONTACTS

Eisai Co., Ltd.

Investor Relations Department

TEL: +81 (0) 3-3817-5122

Biogen Inc.

Tim Power

+ 1-781-464-2442

[email protected]

Notes to Editors

About lecanemab (generic name, brand name: LEQEMBI®)
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 (Aβ).Lecanemab has been approved in 53 countries and regions including Japan, the U.S., 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 is approved in 8 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. For subcutaneous initiation treatment (500 mg), approval was obtained in the United States in July 2026, and applications are under review in four countries, including Japan and China. In China, the application has been granted Priority Review designation. Since 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.

LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.

To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.

LEQEMBI also rapidly reduced plaque as early as three months (−59.1 CL difference vs placebo in amyloid level at 18 months; P<0.00001).* Additionally, LEQEMBI continued to show benefit over a four-year LTE treatment period; in a subgroup analysis, 81 percent of LEQEMBI patients who stayed on treatment remained in the early AD stages at four years.**

Over three years of treatment, including both the core study and the LTE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI)** cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four-year mark. In Clarity AD, the most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

*The Centiloid scale is used for amyloid PET, where 0 CL is anchored as the average amyloid in young people without amyloid plaques, and 100 is anchored as the average amyloid level in moderate AD.  The baseline centiloid level in CLARITY AD was approximately 78 CL. Plaque negativity is defined as conversion to amyloid PET negative (<30 centiloid, or CL).

**Prespecified subgroup analysis of reduced risk of progression: Progression was defined as CDR-SB score progressing to moderate or severe dementia (≥9.5), based on Kaplan-Meier plots.

About Protofibrils
Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.2 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.3 About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

National Institute on Aging (NIA), National Institutes of Health. What Is Mild Cognitive Impairment? Available at: https://www.nia.nih.gov/health/memory-loss-and-forgetfulness/what-mild-cognitive-impairment. Accessed July 22, 2026. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706. SOURCE Eisai Inc.

Allworth Financial LP acquired a new stake in Biogen Inc. (NASDAQ:BIIB – Free Report) in the 2nd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The fund acquired 8,033 shares of the biotechnology company’s stock, valued at approximately $1,736,000.

A number of other hedge funds have also added to or reduced their stakes in the stock. Bell Investment Advisors Inc purchased a new position in Biogen during the second quarter valued at approximately $27,000. Reflection Asset Management purchased a new stake in Biogen during the fourth quarter worth $25,000. WPG Advisers LLC boosted its position in Biogen by 417.9% during the 4th quarter. WPG Advisers LLC now owns 145 shares of the biotechnology company’s stock valued at $26,000 after acquiring an additional 117 shares in the last quarter. First Horizon Corp bought a new stake in Biogen during the 4th quarter valued at $30,000. Finally, Root Financial Partners LLC increased its holdings in shares of Biogen by 198.4% in the 4th quarter. Root Financial Partners LLC now owns 185 shares of the biotechnology company’s stock valued at $33,000 after acquiring an additional 123 shares during the period. 87.93% of the stock is currently owned by institutional investors.

Wall Street Analysts Forecast Growth Several analysts have commented on BIIB shares. HSBC reissued a “reduce” rating and set a $157.00 price target on shares of Biogen in a research report on Monday, July 6th. UBS Group lifted their price objective on shares of Biogen from $225.00 to $240.00 and gave the stock a “buy” rating in a research report on Thursday, July 30th. TD Cowen boosted their price objective on shares of Biogen from $215.00 to $225.00 and gave the stock a “buy” rating in a research note on Thursday, July 30th. Needham & Company LLC increased their target price on shares of Biogen from $255.00 to $256.00 and gave the company a “buy” rating in a research report on Monday, June 29th. Finally, Freedom Capital upgraded shares of Biogen from a “hold” rating to a “strong-buy” rating in a research note on Friday, May 1st. One analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating, thirteen have assigned a Hold rating and one has assigned a Sell rating to the company. According to MarketBeat, the company currently has an average rating of “Moderate Buy” and an average target price of $227.07.

Check Out Our Latest Analysis on BIIB Biogen Stock Performance BIIB opened at $216.78 on Friday. The firm has a fifty day moving average price of $205.53 and a 200 day moving average price of $194.48. Biogen Inc. has a 1 year low of $131.52 and a 1 year high of $222.15. The stock has a market cap of $32.03 billion, a P/E ratio of 38.37, a P/E/G ratio of 6.68 and a beta of 0.17. The company has a debt-to-equity ratio of 0.39, a current ratio of 1.87 and a quick ratio of 1.26.

Biogen (NASDAQ:BIIB – Get Free Report) last announced its quarterly earnings results on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, beating the consensus estimate of $2.94 by $0.66. The firm had revenue of $2.74 billion during the quarter, compared to analyst estimates of $2.46 billion. Biogen had a return on equity of 11.18% and a net margin of 8.32%.Biogen’s revenue for the quarter was up 3.4% compared to the same quarter last year. During the same quarter in the previous year, the business earned $5.47 EPS. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. Equities research analysts anticipate that Biogen Inc. will post 12.39 earnings per share for the current year.

About Biogen (Free Report)

Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer’s disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.

The company’s marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.

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BIIB's newer drugs, M&A activity and pipeline progress are fueling its turnaround, but declining MS sales remain a key risk.

Lead program now in Phase 1 development August 06, 2026 18:15 ET  | Source: Biogen Inc.

CAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the completion of the acquisition of RayThera Inc., a privately held biotechnology company focused on discovering and developing small-molecule therapies in immunology.

The acquisition strengthens Biogen’s growing immunology portfolio, adding multiple assets that have potential to treat immune-mediated conditions across a range of indications. The lead program entered Phase 1 development in July 2026.

“We are excited about the potential of these immunology assets as we continue to strengthen and diversify our pipeline for long-term growth,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “With the lead program now in Phase 1, this acquisition highlights strong execution on our open innovation model in sourcing external opportunities and reflects our continued investment in immunology as a strategic growth area.”

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This press release contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the PSLRA) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the PSLRA. This press release contains forward-looking statements, including relating to: the anticipated benefits of the RayThera Inc. acquisition (the “Acquisition”); our growing immunology portfolio, including the potential strengthening and diversification of our pipeline for long-term growth; our investment in immunology as a strategic growth area; and the anticipated financial impacts of the Acquisition. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, factors relating to: the possibility that the thresholds for clinical and regulatory milestone payments are never met; results of litigation, settlements and investigations; actions by third parties, including governmental agencies; unexpected costs, charges or expenses resulting from the Acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Acquisition; the risk that Biogen may not be able to successfully integrate the business of RayThera and realize the expected benefits of the Acquisition in a timely manner or at all; uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of date hereof and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated, or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Biogen Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

One of these enterprises was Biogen (BIIB +1.76%), which did quite well in its second quarter. As a reward, investors snapped up the stock, sending it to a nearly 2% gain on the day. This beat the S&P 500 index's 0.2% rise.

A biotech in transition Before market open that day, Biogen published those quarterly figures. For the period, the big biotech's revenue was $2.7 billion, 3% higher year over year. The story was quite different on the bottom line, as net income not under generally accepted accounting principles (non-GAAP, or adjusted) slipped to $536 million, or $3.60 per share, from the year-ago profit of $803 million.

Image source: Getty Images.

Despite the bottom-line swoon, Biogen beat on both revenue and profitability. Analysts tracking the stock were, as a group, estimating $2.4 billion for the former line item and $3.17 per share for adjusted earnings per share (EPS).

As has been the case lately for the company, its growth portfolio of medicines was the motor driving the top-line improvement. Drugs in that category collectively raked in $1.06 billion in revenue, a 24% year-over-year improvement.

Higher expenses for items such as upfront and milestone payments, plus higher interest payments from financing needed to acquire Apellis Pharmaceuticals, affected the biotech's adjusted net income line.

Today's Change

(

1.76

%) $

3.62

Current Price

$

209.23

Making the right moves Biogen updated its full-year guidance. It now expects revenue to rise at a mid-single-digit percentage rate over 2025, where previously it expected a decline at roughly the same rate.

Some of the same factors that drove down second-quarter adjusted earnings were also the key reasons for management's reduction in annual adjusted net income. This guidance was lowered to $12 to $13 per share, from the preceding $14.25 to $15.25.

Usually when a company cuts guidance, particularly for the bottom line, investors react negatively. It's telling that this didn't happen in this case because Mr. Market realizes -- correctly, I believe -- that Biogen's pivot is working, and the growth portfolio will continue to do exactly what it says on the label.

Revenue Tops Expectations On Growth Across Key ProductsThe Alzheimer’s drug maker reported revenues of $2.736 billion, beating the consensus of $2.458 billion, up 3% on a reported and 2% on a constant currency basis.

Spinraza revenue of $402 million, up 2% year-over-year, driven by demand and stocking for the high-dose regimen, partially offset by shipment timing in certain ex-U.S. markets; conversion to the high-dose

regimen has been ahead of company expectations in all launched geographies.

Vumerity revenue of $197 million, down 7% year-over-year, primarily impacted by inventory dynamics; first half growth of 7% year-over-year.

Leqembi (Alzheimer’s drug) revenue was $184 million, with U.S. in-market sales of around $97 million.

Revenues from Skyclarys (Friedreich’s ataxia drug), acquired via the Reata acquisition, reached $168 million, up 29%.

Zurzuvae’s (postpartum depression drug) revenue of $71 million, up 53%, was driven by demand growth.

Biogen completed the acquisition of Apellis, adding Syfovre and Empaveli to its portfolio, which contributed $128 million in revenue and are expected to grow in the mid- to high-teens through 2028.

Biogen Raises Full-Year GuidanceThe company raised its fiscal 2026 adjusted earnings guidance from $15.25-$16.25 to $15.85-$16.85, compared to the consensus of $12.83.

Full-year total revenue is now expected to increase by a mid-single-digit percentage for 2026 vs. 2025.

Pipeline AdvancesBiogen also shared Phase 2 data for BIIB091 in relapsing-remitting multiple sclerosis, which showed that BIIB091 has achieved proof-of-concept, and the company will be exploring next steps for the asset.

As part of the option exercise, Biogen paid Ionis a $15 million one-time license fee.

Barclays maintains Equal-Weight on Biogen, while raising the price forecast from $185 to $200.

BIIB Price Action: Biogen shares were up 1.99% at $209.70 at the time of publication on Wednesday, according to Benzinga Pro data.

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Biogen Inc. (BIIB - Free Report) reported $2.74 billion in revenue for the quarter ended June 2026, representing a year-over-year increase of 3.4%. EPS of $3.60 for the same period compares to $5.47 a year ago.

The reported revenue compares to the Zacks Consensus Estimate of $2.5 billion, representing a surprise of +9.4%. The company delivered an EPS surprise of +18.42%, with the consensus EPS estimate being $3.04.

While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.

As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately.

Here is how Biogen performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenue- Product- Rare Disease- SPINRAZA- United States: $204.3 million versus $149.18 million estimated by 22 analysts on average. Compared to the year-ago quarter, this number represents a +36.8% change.Revenue- Product- Multiple Sclerosis (MS)- United States: $621 million compared to the $573 million average estimate based on 21 analysts. The reported number represents a change of -5.5% year over year.Revenue- Product- Rare Disease- SKYCLARYS - United States: $82.3 million versus the 21-analyst average estimate of $84.27 million. The reported number represents a year-over-year change of +5.5%.Revenue- Product- Multiple Sclerosis (MS)- Interferon- United States: $146.1 million versus the 21-analyst average estimate of $138.46 million. The reported number represents a year-over-year change of -2.6%.Revenue- Anti-CD20 therapeutic programs: $513.5 million compared to the $473.33 million average estimate based on 25 analysts. The reported number represents a change of +9.9% year over year.Revenue- Contract manufacturing, royalty and other revenue: $242.4 million versus $151.82 million estimated by 23 analysts on average.Revenue- Product- Multiple Sclerosis (MS)- Fumarate- Total: $287.4 million compared to the $308.1 million average estimate based on 23 analysts. The reported number represents a change of -29.2% year over year.Alzheimer's collaboration revenue: $63.7 million versus $65.97 million estimated by 23 analysts on average. Compared to the year-ago quarter, this number represents a +16% change.Revenue- Product- Rare Disease- SKYCLARYS- Total: $167.9 million versus $154.66 million estimated by 23 analysts on average. Compared to the year-ago quarter, this number represents a +28.9% change.Revenue- Product- Rare Disease- SPINRAZA- Total: $401.9 million compared to the $379.46 million average estimate based on 23 analysts. The reported number represents a change of +2.3% year over year.Revenue- Product- Multiple Sclerosis (MS)- TYSABRI- Total: $450.8 million versus the 23-analyst average estimate of $374.73 million. The reported number represents a year-over-year change of -0.8%.Revenue- Product- Biosimilars- Total: $152.8 million versus the 22-analyst average estimate of $160.18 million. The reported number represents a year-over-year change of -15.9%.View all Key Company Metrics for Biogen here>>>

Shares of Biogen have returned -4.8% over the past month versus the Zacks S&P 500 composite's +1.9% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

Key Takeaways South Korean Measures to Cap Volatility for 1st TimeDiscussions Abound Whether the Fed May Raise Interest RatesPG Mixed, HUM and BIIB Beat, VFC Misses on Quarterly Numbers Wednesday, July 29th, 2026

Pre-market futures are flat-to-down ahead of today’s open, with overseas turbulence in the memory chip market reverberating on domestic shores. We also see something of a hesitation in trading ahead of this afternoon’s Fed decision on interest rates. The Dow is off -340 points at this hour, the tech-heavy Nasdaq is -7, while the S&P 500 and small-cap Russell 2000 are flat.

Saudi Arabia attacked Iran-backed forced in Iraq, demonstrating a further widening of the conflict that originally had been contained to the U.S. and Israel versus Iran. Spot oil prices are back up again this morning, but still just in the $80s per barrel (/bbl); a week ago, Brent crude had surged back over $100/bbl.

South Korean Finance Takes Measures to Calm Market
The finance minister of South Korea overnight has initiated caps on single-stock leveraged ETFs — a clear move to quiet market volatility related to SK Hynix (SKHY - Free Report) , one of the top memory chip producers in the world, which is a key component in the AI trade. The Korean stock market, KOSPI, was down another -6%, -15% over the last week.

This is reportedly the first time the country has applied the breaks to a particular stock trading entity, and it comes the day SK Hynix missed on both top and bottom lines in its first publicly trading earnings report this morning. Both operating profits and sales, however, rose triple-digits in the quarter. The company, one of the biggest suppliers to NVIDIA (NVDA - Free Report) , is down -1% on the news, -22% since its IPO less than three weeks ago.

FOMC Decision: No Longer a Slam Dunk?
The Federal Open Market Committee (FOMC) concludes its fifth meeting so far in 2026, and the first one where analysts have an inkling something might change on the Fed funds rate. Particularly, a quarter-points rate hike has been bandied about as a possibility today over the past week or so, likely due to inflation rates dancing up around +4% over the past couple months and uncertainties around the Strait of Hormuz.

With Fed Chair Kevin Warsh’s new methodology intentionally less transparent than the last three Fed chairs (Ben Bernanke, Janet Yellen and Jerome Powell), it’s tough to get a read on what results his leadership will glean this afternoon at 2pm ET. But from this vista, despite whether more hawkish members of the Fed cast their votes to raise interest rates, it’s hard to see a Warsh-led consensus bringing this about so early into his tenure. Unless he’s looking for a fight from President Trump.

Q2 Roundup at a Glance: PG, HUM & More
Procter & Gamble (PG - Free Report) beat on fiscal Q4 earnings this morning by 2 cents per share, while missing slightly on its top line to $21.2 billion, above the $20.89 billion reported a year ago. For more on PG’s earnings, click here.

Health insurance giant Humana (HUM - Free Report) posted a huge Q2 earnings beat this morning: $7.61 per share versus $6.22 in the Zacks consensus, for a +22.35% positive earnings surprise. Revenues of $40.89 billion outpaced expectations by +0.59%. For more on HUM’s earnings, click here.

Biotech major Biogen (BIIB - Free Report) provided one of the strongest quarterly reports of the morning, with Q2 earnings of $3.60 per share well above the $3.04 projected, on revenues of $2.74 billion which outperformed estimates by +9.4%. For more on BIIB’s earnings, click here.

Vans, Timberland and The North Face parent V.F. Corp. (VFC - Free Report) posted its first earnings miss in the last four quarters: -$0.27 per share versus -$0.22 expected. Revenues of $1.67 billion was -0.29% below consensus. For more on VFC’s earnings, click here.

After the close, we’ll see results from two key “Mag 7” companies, Microsoft (MSFT - Free Report) and Meta Platforms (META - Free Report) , In addition, reports are also due from Qualcomm (QCOM - Free Report) and Starbucks (SBUX - Free Report) , among others, this afternoon.

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