Biogen

biibNASDAQModerate Risk

Neurology-focused biologics and small-molecule development platform

Reviewed by Blane Jackson, DDS, MBA. Educational analysis only. Read the editorial policy and disclosures.

Market cap

Large cap

Cash position

Strong multibillion-dollar cash balance supported by commercial neurology franchises.

Revenue status

commercial stage

Pipeline assets

3 programs

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What does Biogen do?

Biogen is a commercial-stage biotech company that investors generally judge on execution, not just science. The current story revolves around Leqembi, Zurzuvae, BIIB080, because those assets drive the next important valuation checkpoints. If the lead program keeps advancing cleanly, investors can start to believe the broader platform has durable value. If timelines move, safety issues surface, or commercial adoption falls short, the market can reset expectations quickly. That is why the balance sheet matters here as much as the pipeline. A runway of roughly 48 months gives management some room to operate, but it is not a substitute for real clinical or commercial progress. In plain English, this is a company with real upside if management delivers, but it is still exposed to the classic biotech mix of binary data, regulatory uncertainty, competitive pressure, and financing risk. Investors should also pay attention to how management communicates setbacks, prioritizes spend, and chooses which programs deserve the most resources, because those decisions often matter almost as much as the raw data itself. The market usually rewards clarity, discipline, and repeatable execution. Investors should focus on whether the next round of updates materially de-risks the business or simply extends the waiting period. The stock can outperform if evidence improves faster than expectations, but it can also sell off hard if even one key assumption breaks.

What to watch

1

Whether Leqembi meets the next commercial or clinical milestone cleanly.

2

Any shift in timing, safety, or regulator tone around Zurzuvae.

3

Cash runway discipline and whether management can fund the pipeline without damaging dilution.


Pipeline

DrugIndicationPhaseExpected data
LeqembiAlzheimer diseaseApprovedNot disclosed
Zurzuvaepostpartum depressionApprovedNot disclosed
BIIB080tau-targeting therapy for Alzheimer diseasePhase 2Not disclosed

Investment thesis

Bull case

Biogen offers investors a clearer path than many biotech peers because it already has meaningful commercial infrastructure and cash generation. The core bullish case rests on Leqembi and Zurzuvae, which together give the story both nearer-term execution markers and longer-duration upside. If management continues to hit development milestones, the market could assign more value to the rest of the pipeline and to the underlying neurology-focused biologics and small-molecule development platform. Just as important, Biogen operates in therapeutic areas where strong clinical data can change sentiment quickly. For investors comfortable with biotech volatility, that combination of identifiable catalysts, platform optionality, and a still-debatable valuation can create an attractive setup over the next twelve to eighteen months.

Bear case

The bear case is that Biogen still has to prove more than headline enthusiasm suggests. Biotech valuations can compress quickly when timelines slip, safety signals emerge, or commercial adoption disappoints, and Biogen is exposed to each of those risks in some form. Leqembi may face competitive, reimbursement, or durability questions, while Zurzuvae still needs to deliver the kind of evidence that meaningfully changes financial expectations. If one or two key catalysts miss, investors could refocus on burn, concentration risk, or the reality that promising science does not always become durable revenue. In a harder financing or risk-off market, the stock could remain volatile even if the long-term scientific story stays intact.

Key upcoming catalysts

Salanersen SMA 15-60y: Salanersen (BIIB115) in Spinal muscular atrophy, ages 15-60 — primary completion

2028-06-23

Registry milestone — the date data collection is scheduled to end, not when results are released. ClinicalTrials.gov

Trial milestoneSignificant

Salanersen presymptomatic infants: Salanersen (BIIB115) in Presymptomatic spinal muscular atrophy — primary completion

2028-11-28

Registry milestone — the date data collection is scheduled to end, not when results are released. ClinicalTrials.gov

Trial milestoneSignificant

Salanersen post-onasemnogene: Salanersen (BIIB115) in SMA after onasemnogene abeparvovec — primary completion

2029-07-27

Registry milestone — the date data collection is scheduled to end, not when results are released. ClinicalTrials.gov

Trial milestoneSignificant

Risk factors

Clinical data may not replicate earlier signals.

Regulatory timing or label scope could shift.

Commercial uptake or competitive positioning may disappoint.

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Comparable companies

RocheEisaiSage Therapeutics

Financial snapshot

These figures are drafted by our AI pipeline, not read from SEC filings. Confirm anything you would act on against the company's latest 10-Q or 10-K.

Cash

Strong multibillion-dollar cash balance supported by commercial neurology franchises.

Quarterly burn

Commercial company with positive product revenue and ongoing R&D investment.

Cash runway

Not derivable

cash or burn not disclosed as a figure

Revenue

commercial stage

Institutional ownership

88%

Source: company profile text. These figures come from the company profile text, not from a filing we have parsed. Check them against the latest 10-Q before relying on them.

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Disclaimer: This page is for informational and educational purposes only and does not constitute financial advice or a recommendation to buy or sell securities. Clinical trial analysis reflects publicly available data and AI-generated interpretations. Biotech investing carries significant risk including potential total loss of investment. Always verify critical claims through primary sources and consult a qualified financial advisor. Some links on this page are affiliate links. Review our editorial policy and disclosures.

Sponsor's late-stage trial record

Biogen has 205 Phase 2 or 3 studies on ClinicalTrials.gov: 119 completed, 66 stopped early, 20 ongoing.

119

Completed

66

Stopped early

20

Ongoing

Stopped early

  • DAISYPhase 2 · started 2024 · withdrawn

    BIIB131 in ischemic stroke · n=0

    Reason given: Sponsor decision

  • CYPRESSPhase 2 · started 2023 · terminated

    RTA 901 in diabetic peripheral neuropathic pain · n=209

    Reason given: Sponsor decision to close study early; not due to safety concerns.

  • SURGE-1Phase 3 · started 2023 · withdrawn

    BIIB074 in trigeminal neuralgia · n=0

    Reason given: Sponsor Decision

  • SURGE-2Phase 3 · started 2023 · withdrawn

    BIIB074 in trigeminal neuralgia · n=0

    Reason given: Sponsor Decision

  • LIGHTHOUSEPhase 3 · started 2022 · terminated

    BIIB122 in parkinson disease · n=7

    Reason given: Sponsor Decision

  • ENVISIONPhase 3 · started 2022 · terminated

    Aducanumab in alzheimer's disease · n=1027

    Reason given: Sponsor's Decision

  • NCT05265728Phase 3 · started 2022 · terminated

    Natalizumab in multiple sclerosis, relapsing-remitting · n=21

    Reason given: Due to sponsor decision, not for efficacy or safety reasons.

  • NCT04079088Phase 2 · started 2021 · withdrawn

    Placebo in relapsing multiple sclerosis · n=0

    Reason given: Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.

  • ALSpirePhase 1/2 · started 2020 · terminated

    BIIB105 in amyotrophic lateral sclerosis · n=99

    Reason given: Sponsor's decision

  • NCT04241068Phase 3 · started 2020 · terminated

    Aducanumab in alzheimer's disease · n=1696

    Reason given: Sponsor's Decision

  • NCT04007367Phase 3 · started 2019 · terminated

    SAGE-217 in major depressive disorder · n=53

    Reason given: Internal company decision

  • FALCONPhase 3 · started 2019 · terminated

    Bardoxolone methyl oral capsule in autosomal dominant polycystic kidney · n=667

    Reason given: Discontinuation of all bardoxolone chronic kidney disease programs

  • NCT03870763Phase 3 · started 2019 · terminated

    Dimethyl Fumarate in multiple sclerosis, relapsing-remitting · n=11

    Reason given: Decision to stop the trial was based on long-term difficulties in fulfilling our enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials.Decision to stop study was not based on safety concerns.

  • EAGLEPhase 3 · started 2019 · terminated

    Bardoxolone methyl in chronic kidney diseases · n=270

    Reason given: Discontinuation of all bardoxolone chronic kidney disease programs

  • NCT03771664Phase 3 · started 2019 · terminated

    SAGE-217 in major depressive disorder · n=87

    Reason given: internal company decision

  • EVOLVEPhase 2 · started 2018 · terminated

    Aducanumab in cognitive dysfunction · n=52

    Reason given: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.

  • SPIRITPhase 2 · started 2018 · terminated

    BG00011 in idiopathic pulmonary fibrosis · n=109

    Reason given: Study was stopped because of safety concerns.

  • NCT03339336Phase 2 · started 2018 · terminated

    BIIB074 in small fiber neuropathy · n=265

    Reason given: Sponsor decision to close study early; not due to safety concerns

  • TANGOPhase 2 · started 2018 · terminated

    BIIB092 in alzheimer's disease · n=654

    Reason given: The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.

  • SPARKPhase 2 · started 2018 · terminated

    Placebo in parkinson's disease · n=357

    Reason given: SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.

  • AFFINITYPhase 2 · started 2017 · terminated

    BIIB033 (opicinumab) in multiple sclerosis · n=263

    Reason given: The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.

  • PASSPORTPhase 2 · started 2017 · terminated

    BIIB092 in supranuclear palsy, progressive · n=490

    Reason given: 251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.

  • RANGERPhase 3 · started 2017 · terminated

    Bardoxolone methyl in pulmonary hypertension · n=261

    Reason given: The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk.

  • SUSTAINPhase 3 · started 2017 · terminated

    Daclizumab in relapsing-remitting multiple sclerosis (rrms) · n=41

    Reason given: Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS.

  • RELAY-1 ExtendPhase 2 · started 2017 · terminated

    BIIB074 in neuropathic pain from lumbosacral radiculopathy · n=302

    Reason given: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.

  • NCT02657356Phase 3 · started 2016 · terminated

    Placebo capsules in connective tissue disease-associated pulmonary arterial hypertension · n=202

    Reason given: Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health

  • NCT02855411Phase 2 · started 2016 · terminated

    PF-04958242 in cognitive impairment associated with schizophrenia (cias) · n=35

    Reason given: Terminated prematurely Sept 22, 2016 following an internal portfolio prioritization. It is not due to any safety concern or change in benefit:risk assessment.

  • NCT02428218Phase 3 · started 2016 · withdrawn

    dimethyl fumarate in relapsing-remitting multiple sclerosis · n=0

    Reason given: Feasibility

  • EMERGEPhase 3 · started 2015 · terminated

    Aducanumab (BIIB037) in alzheimer's disease · n=1643

    Reason given: Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed

  • EMBRACEPhase 2 · started 2015 · terminated

    Nusinersen in spinal muscular atrophy · n=21

    Reason given: The study was terminated early to roll over participants to open label extension study NCT02594124.

  • ENGAGEPhase 3 · started 2015 · terminated

    Aducanumab (BIIB037) in alzheimer's disease · n=1653

    Reason given: Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed

  • INSPIREPhase 3 · started 2015 · terminated

    dimethyl fumarate in multiple sclerosis, secondary progressive · n=58

    Reason given: Sponsor Decision

  • TITRATIONPhase 3 · started 2015 · terminated

    dimethyl fumarate in multiple sclerosis · n=62

    Reason given: Sponsor decision

  • SIMPLIFYPhase 2 · started 2014 · terminated

    natalizumab in relapsing multiple sclerosis · n=2

    Reason given: Sponsor's decision.

  • ENDEARPhase 3 · started 2014 · terminated

    nusinersen in spinal muscular atrophy · n=122

    Reason given: After a positive interim analysis, the decision was made to terminate the study early to allow for participants to enroll into an open label study

  • NCT01930890Phase 2 · started 2013 · terminated

    BIIB023 in lupus nephritis · n=87

    Reason given: Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study

  • EXTENDPhase 3 · started 2013 · terminated

    BIIB019 (Daclizumab) in relapsing-remitting multiple sclerosis · n=1501

    Reason given: Study terminated because of differences in the participant population under study compared with indicated Zinbryta use in most countries.

  • NCT01655186Phase 2 · started 2012 · withdrawn

    Bardoxolone Methyl in renal insufficiency, chronic · n=0

    Reason given: IDMC recommendation for safety concerns

  • EMBRACEPhase 2 · started 2012 · withdrawn

    BIIB057 in rheumatoid arthritis · n=0

    No reason recorded in the registry.

  • NCT01576887Phase 2 · started 2012 · withdrawn

    Bardoxolone Methyl 20 mg in end-stage renal disease · n=0

    Reason given: IDMC recommendation for safety concerns

  • ATLASPhase 2 · started 2012 · terminated

    BIIB023 in lupus nephritis · n=276

    Reason given: Results from pre-specified criteria did not demonstrate sufficient efficacy to warrant continuation of the study.

  • ASCEND in SPMSPhase 3 · started 2011 · terminated

    natalizumab in secondary progressive multiple sclerosis · n=889

    Reason given: The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.

  • BEACONPhase 3 · started 2011 · terminated

    Placebo in renal insufficiency, chronic · n=2185

    Reason given: IDMC recommendation for safety concerns

  • NCT01181089Phase 1/2 · started 2010 · withdrawn

    Placebo in secondary progressive multiple sclerosis · n=0

    No reason recorded in the registry.

  • SURPASSPhase 3 · started 2010 · terminated

    BG00002 (natalizumab) in relapsing remitting multiple sclerosis · n=84

    Reason given: Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.

  • POSEIDONPhase 2 · started 2009 · terminated

    Tonapofylline in renal insufficiency · n=34

    Reason given: Company Decision

  • NCT00746941Phase 1/2 · started 2009 · terminated

    mefloquine in progressive multifocal leukoencephalopathy · n=37

    Reason given: Primary endpoint not achieved

  • NCT00784836Phase 3 · started 2008 · terminated

    BG9418 (interferon beta 1-a) in multiple sclerosis · n=3

    Reason given: Terminated early by Sponsor for business reasons unrelated to safety.

  • NCT00675428Phase 1/2 · started 2008 · terminated

    BG00002 (natalizumab) in multiple myeloma · n=6

    Reason given: Sponsor decision due to low enrollment and not safety concerns.

  • NCT00801060Phase 2 · started 2008 · terminated

    Lumiliximab + FCR in chronic lymphocytic leukemia · n=40

    No reason recorded in the registry.

  • NCT00384150Phase 3 · started 2007 · terminated

    galiximab in combination with rituximab in lymphoma, non-hodgkin's · n=16

    Reason given: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.

  • RESPOND-EXTPhase 2 · started 2007 · terminated

    Baminercept alfa (BG9924) in rheumatoid arthritis · n=339

    Reason given: Analysis of data from 104RA202 failed to meet primary endpoint

  • NCT00538343Phase 2 · started 2007 · terminated

    berubicin hydrochloride (RTA 744) in brain metastases · n=14

    Reason given: Business Decision

  • NCT00523328Phase 2 · started 2007 · terminated

    BG9924 in rheumatoid arthritis · n=72

    Reason given: Analysis of data from 104RA203 failed to meet primary endpoint.

  • NCT00550849Phase 1/2 · started 2007 · terminated

    RTA 402 in liver disease · n=16

    Reason given: Enrollment discontinued after second cohort completed.

  • NCT00458861Phase 2 · started 2007 · terminated

    BG9924 in rheumatoid arthritis · n=115

    Reason given: Interim analysis of data failed to meet primary endpoint.

  • LUCIDPhase 2 · started 2006 · terminated

    FCR + Lumiliximab in chronic lymphocytic leukemia · n=627

    No reason recorded in the registry.

  • NCT00363636Phase 3 · started 2006 · terminated

    Galiximab in combination with rituximab in lymphoma, non-hodgkin's · n=340

    Reason given: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.

  • NCT00298272Phase 2 · started 2006 · terminated

    IDEC-C2B8 (rituximab) in rheumatoid arthritis · n=54

    Reason given: Sponsor decided to end long term extension phase for business reasons unrelated to safety.

  • STRATAPhase 3 · started 2006 · terminated

    Natalizumab in relapsing-remitting multiple sclerosis · n=1094

    No reason recorded in the registry.

  • NCT00102024Phase 1/2 · started 2005 · terminated

    Unconjugated IDEC-159 in colorectal cancer · n=30

    No reason recorded in the registry.

  • NCT00831649Phase 2 · started 2004 · terminated

    natalizumab in rheumatoid arthritis

    Reason given: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.

  • NCT00083759Phase 2 · started 2004 · terminated

    natalizumab in rheumatoid arthritis · n=299

    Reason given: The biological effect seen with natalizumab was not sufficient to warrant further development in RA.

  • NCT00057343Phase 3 · started 2003 · terminated

    Zevalin (ibritumomab tiuxetan) in non-hodgkin's lymphoma · n=400

    No reason recorded in the registry.

  • NCT00535314Phase 2 · started · withdrawn

    RTA 402 Dose1 in malignant melanoma · n=0

    No reason recorded in the registry.

  • NCT00451815Phase 2 · started · withdrawn

    active drug (BIIB014) at 10, 30, 100, or 300 mg once daily. in parkinson's disease · n=0

    No reason recorded in the registry.

Counts cover interventional Phase 2 and Phase 3 studies registered under this sponsor name, retrieved 2026-09-13 from ClinicalTrials.gov API v2. Trials stop for many reasons — futility, safety, enrollment, funding, or a decision to back a different programme — and the registry often does not say which. This is the sponsor's record, not a prediction about any specific readout.