Amgen

amgnNASDAQModerate Risk

Large-scale biologics development with targeted oncology and inflammation capabilities

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

Market cap

Large cap

Cash position

Substantial operating cash flow and balance sheet flexibility from mature commercial portfolio.

Revenue status

commercial stage

Pipeline assets

3 programs

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What does Amgen do?

Amgen is a commercial-stage biotech company that investors generally judge on execution, not just science. The current story revolves around TEPEZZA, MariTide, Tarlatamab, 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 60 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 TEPEZZA meets the next commercial or clinical milestone cleanly.

2

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

3

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


Pipeline

DrugIndicationPhaseExpected data
TEPEZZAthyroid eye diseaseApprovedNot disclosed
MariTideobesity and overweightPhase 2Not disclosed
Tarlatamabsmall cell lung cancerApprovedNot disclosed

Investment thesis

Bull case

Amgen 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 TEPEZZA and MariTide, 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 large-scale biologics development with targeted oncology and inflammation capabilities. Just as important, Amgen 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 Amgen 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 Amgen is exposed to each of those risks in some form. TEPEZZA may face competitive, reimbursement, or durability questions, while MariTide 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

DeLLphi-312: Tarlatamab in Untreated extensive-stage small-cell lung cancer — primary completion

2029-01-04

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

Trial milestoneSignificant

Etelcalcetide paediatric: Etelcalcetide in Secondary hyperparathyroidism on haemodialysis — primary completion

2029-01-31

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

Regeneron PharmaceuticalsAbbVieGilead Sciences

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

Substantial operating cash flow and balance sheet flexibility from mature commercial portfolio.

Quarterly burn

Commercial company with broad portfolio funding late-stage pipeline and M&A integration.

Cash runway

Not derivable

cash or burn not disclosed as a figure

Revenue

commercial stage

Institutional ownership

78%

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.

Sponsored

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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

Amgen has 600 Phase 2 or 3 studies on ClinicalTrials.gov: 455 completed, 75 stopped early, 66 ongoing, 4 other.

455

Completed

75

Stopped early

66

Ongoing

Stopped early

  • NCT06527404Phase 3 · started 2024 · terminated

    Rocatinlimab in prurigo nodularis · n=469

    Reason given: Sponsor Decision

  • NCT06376045Phase 2 · started 2024 · terminated

    Rocatinlimab in asthma · n=317

    Reason given: Sponsor Decision

  • NCT06312020Phase 2 · started 2024 · terminated

    HZN-1116 in sjogren's syndrome · n=209

    Reason given: The study was terminated by sponsor due to meeting pre-defined criteria for futility.

  • NCT05323617Phase 2 · started 2023 · withdrawn

    Romiplostim in severe aplastic anemia (saa) · n=0

    Reason given: Operational

  • ROCKET-ASCENDPhase 3 · started 2023 · terminated

    Rocatinlimab in atopic dermatitis · n=2621

    Reason given: Sponsor Decision

  • NCT05672199Phase 2 · started 2023 · terminated

    Efavaleukin alfa in ulcerative colitis · n=25

    Reason given: The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.

  • NCT05540665Phase 2 · started 2023 · terminated

    Daxdilimab in lupus nephritis · n=19

    Reason given: Sponsor Decision

  • NCT05591222Phase 2 · started 2022 · terminated

    Placebo in discoid lupus erythematosus · n=72

    Reason given: Sponsor business decision, not related to safety concerns.

  • NCT05626751Phase 2 · started 2022 · terminated

    HZN-825 in diffuse cutaneous systemic sclerosis · n=174

    Reason given: The study was not stopped due to safety reasons

  • FORTITUDE-301Phase 1/2 · started 2022 · terminated

    Bemarituzumab in solid tumors · n=260

    Reason given: Sponsor Decision

  • RECAST SLE OLEPhase 2 · started 2022 · terminated

    Daxdilimab in systemic lupus erythematosus · n=155

    Reason given: Sponsor Decision

  • FORTITUDE-103Phase 1/2 · started 2022 · terminated

    Bemarituzumab in gastric cancer · n=72

    Reason given: Sponsor Decision

  • FORTITUDE-102Phase 3 · started 2022 · terminated

    Bemarituzumab in gastric cancer · n=515

    Reason given: Study was terminated by sponsor

  • NCT04987307Phase 2 · started 2022 · terminated

    Efavaleukin alfa in ulcerative colitis · n=221

    Reason given: The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.

  • CodeBreaK201Phase 2 · started 2022 · terminated

    Sotorasib in non-small cell lung cancer · n=42

    Reason given: Futility

  • NCT05032066Phase 2 · started 2022 · terminated

    HZN-825 in idiopathic pulmonary fibrosis · n=153

    Reason given: The trial was terminated due to not meeting primary or key secondary endpoints.

  • NCT04781543Phase 2 · started 2021 · terminated

    HZN-825 BID in diffuse cutaneous systemic sclerosis · n=301

    Reason given: The study was terminated due to meeting pre-defined criteria for futility.

  • NCT04466917Phase 3 · started 2021 · withdrawn

    ABP 215 in metastatic non-small cell lung cancer (nsclc) · n=0

    Reason given: Sponsor decision to early terminate the study

  • NCT04680637Phase 2 · started 2021 · terminated

    Efavaleukin Alfa in active systemic lupus erythematosus · n=168

    Reason given: The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.

  • NCT04631601Phase 1/2 · started 2021 · terminated

    Acapatamab in metastatic castration-resistant prostate cancer · n=55

    Reason given: Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.

  • NCT04174677Phase 2 · started 2019 · withdrawn

    Inebilizumab in highly sensitized patients on waiting list for kidney transplantation · n=0

    Reason given: Stopped due to no enrollment

  • NCT03433755Phase 3 · started 2019 · terminated

    evolocumab in primary hypercholesterolemia · n=259

    Reason given: Prematurely Discontinued Amgen decision

  • NCT03809663Phase 2 · started 2019 · terminated

    Tezepelumab in atopic dermatitis · n=251

    Reason given: Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level pre-established for this patient population.

  • NCT03619187Phase 3 · started 2018 · withdrawn

    Ivabradine in heart transplantation, elevated resting heart rate · n=0

    Reason given: Sponsor decision

  • NCT03703908Phase 2 · started 2018 · terminated

    CCX140-B in focal segmental glomerulosclerosis · n=5

    Reason given: Program not advancing

  • NCT03638128Phase 3 · started 2018 · terminated

    Denosumab in osteogenesis imperfecta (oi) · n=75

    Reason given: The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants

  • NCT03512353Phase 2 · started 2018 · terminated

    Dexamethasone in relapsed or refractory multiple myeloma · n=7

    Reason given: Sponsor Decision

  • NCT03298412Phase 2 · started 2018 · terminated

    Blinatumomab in high-risk diffuse large b-cell lymphoma · n=10

    Reason given: Early Closure due to rare patient population

  • NCT03410056Phase 1/2 · started 2018 · terminated

    Efavaleukin alfa in rheumatoid arthritis ra · n=36

    Reason given: Amgen made a business decision not to proceed with Phase 2.

  • NCT03422627Phase 1/2 · started 2018 · terminated

    Efavaleukin Alfa in chronic graft versus host disease cgvhd · n=32

    Reason given: Sponsor Decision

  • NCT03343847Phase 3 · started 2018 · withdrawn

    Romiplostim in chemotherapy-induced thrombocytopenia · n=0

    Reason given: Study was not feasible

  • NCT03080935Phase 3 · started 2017 · terminated

    Evolocumab in dyslipidemia · n=1600

    Reason given: Amgen business decision to close study early

  • OIPhase 3 · started 2015 · terminated

    Denosumab in osteogenesis imperfecta · n=153

    Reason given: The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants

  • NCT02473445Phase 2 · started 2015 · terminated

    Cysteamine Bitartrate in mitochondrial diseases · n=22

    Reason given: Sponsor decision to end development of RP103 for mitochondrial disease due to lack of efficacy demonstrated in base study RP103-MITO-001.

  • NCT02429882Phase 2 · started 2015 · withdrawn

    Brodalumab 210 mg in axial spondyloarthritis · n=0

    Reason given: Per Amgen's decision to discontinue co-development and co-commercialization of brodalumab, study is being cancelled/closed.

  • MASTERKEY-265Phase 3 · started 2014 · terminated

    Talimogene Laherparepvec in melanoma · n=713

    No reason recorded in the registry.

  • NCT02227914Phase 1/2 · started 2014 · withdrawn

    Oprozomib in advanced hepatocellular carcinoma · n=0

    Reason given: Study stopped due to administrative reasons

  • NCT02138838Phase 3 · started 2014 · terminated

    Cinacalcet HCl in chronic kidney disease, secondary hyperparathyroidism · n=55

    Reason given: Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.

  • RILOMET-2Phase 3 · started 2014 · terminated

    Rilotumumab in gastric cancer · n=34

    Reason given: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.

  • NCT02016534Phase 2 · started 2014 · terminated

    AMG 337 in stomach neoplasms · n=60

    Reason given: Amgen decision following interim review of efficacy and safety data from the AMG 337 program.

  • NCT02013167Phase 3 · started 2014 · terminated

    Blinatumomab in relapsed/refractory b-precursor acute lymphoblastic leukemia · n=405

    No reason recorded in the registry.

  • NCT01881789Phase 1/2 · started 2013 · terminated

    Oprozomib in multiple myeloma · n=22

    Reason given: A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in OPZ003 was halted during dose-escalation.

  • NCT01832727Phase 1/2 · started 2013 · terminated

    Oprozomib in multiple myeloma · n=65

    Reason given: Enrollment halted during phase 2 to reformulate the investigational product

  • NCT01902290Phase 2 · started 2013 · terminated

    Placebo in asthma · n=421

    Reason given: Study terminated early due to lack of efficacy observed following interim analysis in Q2 2015. Study Closed once all sites were closed in eClinical

  • RILOMET-1Phase 3 · started 2012 · terminated

    Rilotumumab in gastric cancer · n=609

    Reason given: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.

  • NCT01439867Phase 2 · started 2012 · terminated

    Cinacalcet hydrochloride in chronic kidney disease · n=18

    Reason given: Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.

  • NCT01568229Phase 2 · started 2012 · terminated

    AMG 747 in schizophrenia · n=111

    Reason given: Toxic Epidermal Necrolysis

  • NCT01568216Phase 2 · started 2012 · terminated

    AMG 747 in schizophrenia · n=121

    Reason given: Toxic Epidermal Necrolysis

  • NCT01493505Phase 3 · started 2012 · terminated

    AMG 386 in fallopian tube cancer · n=1015

    Reason given: Amgen Administrative Decision - termination of LTFU

  • NCT01416428Phase 1/2 · started 2011 · terminated

    oprozomib in multiple myeloma · n=210

    Reason given: A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in 2011-001 was halted.

  • NCT01277510Phase 3 · started 2011 · terminated

    cinacalcet capsule in chronic kidney disease · n=43

    Reason given: Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.

  • NCT01281254Phase 3 · started 2011 · terminated

    AMG386 plus PLD in fallopian tube cancer · n=223

    Reason given: Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU.

  • NCT01199302Phase 2 · started 2011 · terminated

    Brodalumab in crohn's disease · n=67

    Reason given: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups.

  • NCT01285310Phase 2 · started 2010 · terminated

    Apremilast 30 mg in rheumatoid arthritis · n=237

    Reason given: Study is terminated due to lack of efficacy

  • NCT01150890Phase 2 · started 2010 · terminated

    Brodalumab in crohn's disease · n=130

    Reason given: The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups

  • NCT01059448Phase 2 · started 2010 · terminated

    AMG 827 in rheumatoid arthritis · n=211

    Reason given: Lack of efficacy for Brodalumab in Rheumatoid Arthritis (RA)

  • NCT01077154Phase 3 · started 2010 · terminated

    Placebo in breast cancer · n=4509

    Reason given: Terminated: Amgen decision following Primary Analysis. Not due to safety reason

  • NCT00975104Phase 2 · started 2010 · withdrawn

    AMG 745 0.3 mg/kg in age-associated muscle loss · n=0

    Reason given: Amgen has chosen at this time not to continue with AMG 745 study 20080733

  • NCT00858364Phase 3 · started 2009 · terminated

    Darbepoetin alfa in non-small cell lung cancer · n=2549

    No reason recorded in the registry.

  • NCT00436748Phase 3 · started 2008 · terminated

    Darbepoetin Alfa in anemia · n=116

    Reason given: FDA and EMA agreed that the information that had been submitted to date was acceptable to meet the requirements of the post-marketing commitment.

  • NCT00661921Phase 2 · started 2008 · withdrawn

    AMG 108 in diabetes mellitus · n=0

    Reason given: Program Development discontinued

  • NCT00597909Phase 2 · started 2007 · terminated

    sodium phenylacetate and sodium benzoate injection 10% / 10% in hepatic encephalopathy · n=1

    Reason given: Study was terminated due to lack of enrollment and business decisions.

  • NCT00460317Phase 3 · started 2007 · terminated

    AMG 706 in non-small cell lung cancer · n=1450

    Reason given: Amgen discontinued the development of AMG706 because 20050201 did not meet its primary objective.

  • NCT00369070Phase 2 · started 2007 · terminated

    Bevacizumab in advanced non-squamous nsclc · n=186

    No reason recorded in the registry.

  • APPRISE 1Phase 2 · started 2007 · terminated

    Gemcitabine in cancer of pancreas · n=3

    Reason given: APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data

  • NCT00534456Phase 3 · started 2007 · terminated

    Placebo in anemia · n=12

    Reason given: Study terminated

  • NCT00356681Phase 2 · started 2006 · terminated

    AMG 706 placebo in breast neoplasms · n=282

    Reason given: Sponsor decision to close study

  • NCT00364845Phase 3 · started 2006 · terminated

    Darbepoetin alfa in anemia · n=51

    Reason given: The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns

  • NCT00360867Phase 2 · started 2005 · terminated

    AMG 706 in solid tumors · n=94

    Reason given: Amgen decision

  • NCT00156962Phase 3 · started 2005 · terminated

    Epoetin alfa DT in chronic kidney disease · n=850

    Reason given: Regulatory decision not to proceed

  • NCT00989092Phase 2 · started 2002 · terminated

    darbepoetin alfa in anemia · n=287

    Reason given: slow enrollment and change in product development strategy

  • NCT00537667Phase 2 · started 2001 · terminated

    anakinra in rheumatoid arthritis · n=22

    Reason given: The safety profile of combination therapy became unacceptable.

  • NCT00078806Phase 3 · started 2001 · terminated

    Etanercept in juvenile rheumatoid arthritis · n=19

    Reason given: the study was terminated because of slow enrollment

  • NCT03781375Phase 3 · started 2000 · terminated

    Etanercept in juvenile rheumatoid arthritis · n=25

    No reason recorded in the registry.

  • NCT00119600Phase 1/2 · started · terminated

    AMG 114 in anemia

    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.