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Amgen
(NASDAQ:AMGN)
Amgen (AMGN) vs. SPDR S&P 500 ETF (SPY)
Amgen Business Overview & Revenue Model
Amgen Key Performance Indicators (KPIs)
Highlights where Amgen's products are selling the most, indicating strong markets and potential areas for expansion or risk due to regional economic factors.
Main Street DataAmgen Earnings Call Summary
Amgen Financial Statement Overview
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 35.96B | 33.42B | 28.19B | 26.32B | 25.98B | 25.42B |
| Gross Profit | 23.79B | 20.57B | 19.77B | 19.92B | 19.52B | 19.27B |
| EBITDA | 16.54B | 13.36B | 14.80B | 12.17B | 11.30B | 13.00B |
| Net Income | 7.00B | 4.09B | 6.72B | 6.55B | 5.89B | 7.26B |
Balance Sheet | ||||||
| Total Assets | 90.14B | 91.84B | 97.15B | 65.12B | 61.16B | 62.95B |
| Cash, Cash Equivalents and Short-Term Investments | 9.45B | 11.97B | 10.94B | 9.30B | 8.04B | 10.65B |
| Total Debt | 54.59B | 60.10B | 64.61B | 38.95B | 33.31B | 32.99B |
| Total Liabilities | 80.52B | 85.96B | 90.92B | 61.46B | 54.47B | 53.54B |
| Stockholders Equity | 9.62B | 5.88B | 6.23B | 3.66B | 6.70B | 9.41B |
Cash Flow | ||||||
| Free Cash Flow | 11.54B | 10.39B | 7.36B | 8.79B | 8.38B | 9.89B |
| Operating Cash Flow | 13.13B | 11.49B | 8.47B | 9.72B | 9.26B | 10.50B |
| Investing Cash Flow | -1.65B | -1.05B | -26.20B | -6.04B | 733.00M | -5.40B |
| Financing Cash Flow | -11.04B | -9.41B | 21.05B | -4.04B | -8.27B | -4.87B |
Amgen Technical Analysis
Amgen Risk Analysis
Amgen Peers Comparison
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
78 Outperform | $214.15B | 11.41 | 39.51% | 3.73% | 1.59% | 58.02% | |
77 Outperform | $147.46B | 18.41 | 40.53% | 2.62% | 2.76% | 6407.19% | |
77 Outperform | $172.42B | 24.75 | 81.71% | 3.15% | 11.03% | 65.22% | |
76 Outperform | $120.39B | 12.35 | 8.39% | 4.37% | -9.32% | 120.62% | |
69 Neutral | $95.05B | 15.77 | 33.84% | 5.25% | 1.26% | ― | |
68 Neutral | $138.90B | 14.24 | 10.59% | 7.05% | 4.44% | 128.96% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
Amgen Corporate Events
Amgen Inc’s recent earnings call presented a generally positive sentiment, underscored by a robust financial performance and strategic growth initiatives. The company reported a 12% increase in revenue, driven by significant volume growth and key product performance. While challenges such as increased competition and study delays were acknowledged, the overall outlook remained optimistic, with the positives outweighing the negatives.
Amgen Inc., a leading biotechnology company, focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious illnesses, including cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases. The company is renowned for its cutting-edge research and development in the biotechnology sector.
Amgen Inc. is currently conducting a Phase 3 clinical study, officially titled ‘Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study).’ The study aims to evaluate the safety, tolerability, event-free survival (EFS), and overall survival (OS) of blinatumomab alternating with low-intensity chemotherapy compared to standard of care chemotherapy in older adults with this specific type of leukemia.
Amgen Inc. is conducting a Phase 4 clinical trial titled ‘A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis.’ The study aims to assess the long-term safety of avacopan in treating ANCA-associated vasculitis, a condition that causes inflammation of blood vessels.
Amgen Inc, in collaboration with BeOne Medicines, is conducting a Phase 1b study titled ‘A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)’. The primary aim is to assess the safety and tolerability of subcutaneous tarlatamab in patients with extensive stage small cell lung cancer, a critical area of unmet medical need.
Amgen Inc. is conducting a clinical study titled ‘A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer.’ The primary goal is to evaluate the efficacy of ABP 234 compared to the established pembrolizumab, aiming to provide a new treatment option for this severe condition.
Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)’. The study aims to compare progression-free survival and overall survival between two treatment groups for advanced nonsquamous non-small cell lung cancer (NSCLC).
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet’s Disease (BEAN)’. The study aims to assess the efficacy of apremilast, a drug designed to treat oral ulcers in pediatric patients with Behçet’s Disease, compared to a placebo over a 12-week period.
Amgen Inc. is conducting a Phase 1b study titled ‘A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion’. The primary objective is to determine the maximum tolerated dose and safety profile of AMG 193 when combined with other therapies in patients with these advanced cancers.
Amgen Inc. is conducting a Phase 2a clinical study titled A Phase 2a, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases. The study aims to evaluate the safety and tolerability of two drugs, inebilizumab and blinatumomab, in adults with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This research is significant as it addresses treatment options for these challenging autoimmune conditions.
Amgen Inc. is conducting a pivotal clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)’. The study aims to assess whether maridebart cafraglutide can reduce heart failure events and improve symptoms in patients with heart failure and obesity, marking a significant step in heart failure treatment.
Study Overview: Amgen Inc. is conducting a study titled OCEAN(a)-PreEvent – Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events. The study aims to evaluate the effect of olpasiran, a drug designed to lower elevated lipoprotein(a) levels, on reducing the risk of coronary heart disease death, myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event.
Amgen Inc., in collaboration with BeiGene and BeOne, is conducting a Phase 1 clinical study titled ‘A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer.’ The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMG 509, both as a monotherapy and in combination with other drugs, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Amgen Inc. is conducting a significant clinical study titled ‘A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy.’ The study aims to evaluate the efficacy of the drug tarlatamab compared to a placebo, focusing on progression-free survival and overall survival in patients with LS-SCLC.
Amgen Inc. is conducting a long-term extension study titled A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren’s Syndrome (SS). The primary objective is to assess the safety and tolerability of dazodalibep, a drug aimed at treating Sjögren’s Syndrome, a chronic autoimmune condition. This study is significant as it seeks to provide long-term data on the drug’s effects, potentially offering a new therapeutic option for patients with this condition.
Amgen Inc. is currently recruiting participants for a Phase 1b clinical study titled ‘A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer.’ The study aims to assess the safety and tolerability of the drug combination in treating extensive stage small cell lung cancer (SCLC), a significant concern in oncology due to its aggressive nature.
Amgen Inc. is conducting a Phase 3 clinical study titled A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis. The study aims to assess the long-term safety of the drug apremilast in young patients who have completed prior studies. This research is significant as it addresses the need for effective long-term treatment options for children with these conditions.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.’ The study aims to compare overall survival rates between patients receiving a combination of xaluritamig and abiraterone against those receiving standard treatments like docetaxel, cabazitaxel, or abiraterone alone. This research is significant as it explores new treatment combinations for a challenging form of prostate cancer.
Amgen Inc. is conducting a clinical study titled ‘PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer.’ The study aims to evaluate the efficacy of romiplostim in treating chemotherapy-induced thrombocytopenia (CIT), allowing patients to receive on-time, full-dose chemotherapy. This research is significant as it addresses a common side effect of chemotherapy that can hinder cancer treatment.
Amgen Inc. is currently conducting a Phase 3 clinical study titled A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy. The study aims to compare the overall survival rates of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving Xaluritamig against those receiving either cabazitaxel or a second androgen receptor-directed therapy (ARDT).
Amgen Inc. is conducting a Phase 3 clinical study titled Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis. The study aims to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of etelcalcetide in treating secondary hyperparathyroidism in pediatric patients with chronic kidney disease on hemodialysis.
Amgen Inc. is conducting a Phase 1/1b clinical study titled A Phase 1/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors. The study aims to assess the safety and efficacy of AMG 410, a drug targeting KRAS-altered tumors, either alone or with other agents. This research is significant as KRAS mutations are common in various cancers, and effective treatments are limited.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD).’ The study aims to assess the efficacy of apremilast compared to a placebo in treating juvenile psoriatic arthritis in children aged 5 to under 18. This research is significant as it targets a pediatric population with limited treatment options.
Amgen Inc. is conducting a Phase 1 clinical study titled ‘A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma.’ The study aims to assess the safety and tolerability of AMG 691, a potential treatment for asthma, in both healthy individuals and those with mild-to-moderate asthma.
Amgen Inc. is conducting a Phase 1b study titled A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer. The study aims to assess the safety and tolerability of xaluritamig when used alongside darolutamide or abiraterone in treating metastatic hormone-sensitive prostate cancer (mHSPC).
Amgen Inc. is conducting a Phase 4 clinical study titled ‘A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China.’ The study aims to assess the efficacy of Prolia on lumbar spine bone mineral density (BMD) over a 12-month period in male osteoporosis patients. This research is significant as it targets a specific demographic in Mainland China, potentially enhancing treatment options for osteoporosis in men.
Amgen Inc. is conducting a Phase 1 clinical study titled A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors. The study aims to assess the safety and tolerability of AMG 355, both alone and in combination with pembrolizumab, in patients with advanced solid tumors. It seeks to establish the recommended phase 2 dose and the maximum tolerated dose for AMG 355.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta.’ The study aims to assess the efficacy and safety of romosozumab compared to bisphosphonates over 12 months, focusing on reducing clinical fractures and improving bone mineral density in young patients with Osteogenesis Imperfecta.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301).’ The study aims to assess progression-free survival in patients with KRAS p.G12C mutated metastatic colorectal cancer, comparing the combination of sotorasib, panitumumab, and FOLFIRI against FOLFIRI with or without bevacizumab-awwb.
Amgen Inc. is currently conducting a clinical study titled An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder. The study aims to assess the pharmacokinetics, pharmacodynamics, and safety of inebilizumab in pediatric patients aged 2 to under 18 years with neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for AQP4-IgG antibodies. This research is significant as it targets a rare and severe condition, potentially offering new therapeutic options for young patients.
Amgen Inc. is conducting a Phase 2 study titled ‘A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309).’ The study aims to evaluate the antitumor activity of Tarlatamab in patients with SCLC, a significant step in advancing cancer treatment options.
Amgen Inc. is conducting a Phase 3 clinical study titled A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity. The study aims to demonstrate that maridebart cafraglutide, when added to standard care, is more effective than a placebo in reducing cardiovascular morbidity and mortality among participants with atherosclerotic cardiovascular disease and obesity or overweight conditions.
Amgen Inc. is conducting a clinical study titled ‘An Open-label, Multicenter, Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics (PK) of Blinatumomab in Chinese Pediatric Subjects With Relapsed or Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)’. The study aims to assess the efficacy of blinatumomab, a promising treatment for this aggressive form of leukemia, highlighting its potential significance in pediatric oncology.
Study Overview: Amgen Inc. is conducting a study titled A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination With Standard of Care Compared With Standard of Care Alone on Major Cardiovascular Events in Chinese Patients With Established Atherosclerotic Cardiovascular Disease. The study aims to evaluate the effectiveness of Repatha® combined with standard care in reducing major cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD), highlighting its potential significance in improving patient outcomes.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.' The study aims to evaluate the efficacy and safety of Etelcalcetide in pediatric patients with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis. This study is significant as it addresses a critical need for effective treatments in a vulnerable pediatric population.
Amgen Inc., in collaboration with Asher Biotherapeutics, Inc., is conducting a Phase 1b study titled ‘A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)’. The study aims to assess the safety and tolerability of combining tarlatamab with AB248 in patients with extensive stage small cell lung cancer, a condition with limited treatment options.
Amgen Inc. is conducting a study titled A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis. The study aims to demonstrate the pharmacokinetic and pharmacodynamic similarity between ABP 692 and Ocrelizumab in treating relapsing-remitting multiple sclerosis (RRMS). This study is significant as it could provide a new therapeutic option for RRMS patients, potentially improving treatment accessibility and outcomes.
Study Overview: Amgen Inc. is conducting a Phase 1b clinical study titled ‘AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol).’ The study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AMG 193, alone or combined with other therapies, in patients with advanced thoracic tumors that have MTAP-deletion. This research is significant as it targets a specific genetic deletion, potentially leading to more effective treatments for these aggressive cancers.
Amgen Inc. is conducting a Phase 4 clinical study titled ‘A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China.’ The study aims to assess the efficacy of Prolia® in improving bone mass density (BMD) of the lumbar spine over a 12-month period. This research is significant as it addresses the treatment of glucocorticoid-induced osteoporosis, a condition affecting bone density due to prolonged steroid use.
Amgen Inc. is conducting a Phase 1 clinical study titled ‘Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors.’ The study aims to evaluate the safety and tolerability of AMG 305 in adults, determine the optimal biologically active dose, and recommend a phase 2 dose. This study is significant as it explores a new potential treatment for advanced solid tumors.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis.’ The study aims to evaluate the safety and tolerability of apremilast in children with this condition, highlighting its significance in expanding treatment options for pediatric patients.
Amgen Inc. is conducting a pivotal study titled ‘A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy.’ The main goal is to demonstrate pharmacokinetic similarity between ABP 234 and pembrolizumab, which could offer a new treatment option for early-stage non-squamous non-small cell lung cancer (NSCLC).
Amgen Inc. is conducting a Phase 3 clinical study titled A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies. The study aims to evaluate the effectiveness of rocatinlimab compared to a placebo in treating prurigo nodularis, focusing on patient-reported outcomes and clinical assessments.
Amgen Inc. is currently conducting a Phase 1 clinical study titled A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus. The study aims to assess the impact of maridebart cafraglutide on insulin sensitivity in individuals with Type 2 Diabetes Mellitus who are on a stable dose of metformin, highlighting its potential significance in diabetes management.
Study Overview: Amgen Inc. is conducting a clinical study titled A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma. The study aims to compare the effectiveness and safety of ABP 206 against Nivolumab in patients with advanced melanoma, potentially offering a new treatment option for this challenging condition.
Amgen Inc. is conducting a Phase 2 clinical study titled ‘A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)’. The study aims to assess the safety and efficacy of AMG 193, a drug designed for patients with MTAP-deleted NSCLC, a specific type of lung cancer. This study is significant as it targets a previously treated patient group, potentially offering a new treatment avenue.
Amgen Inc. is conducting a Phase 1b clinical study titled ‘A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy.’ The study aims to assess the safety and tolerability of the drug Xaluritamig in adults with high-risk biochemical recurrent nonmetastatic castration-sensitive prostate cancer, a condition that poses significant health risks.
Amgen Inc. is currently conducting a clinical study titled ‘A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors.’ The study aims to assess the safety, tolerability, and efficacy of AMG 193, both as a standalone treatment and in combination with docetaxel, for patients with advanced MTAP-null solid tumors. This research is significant as it explores potential new treatment avenues for a challenging cancer type.
Amgen Inc. is conducting a study titled ‘Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients.’ The study aims to assess the safety profile of sotorasib, a drug designed for patients with KRAS p.G12C-mutated non-small cell lung cancer (NSCLC) who have undergone prior systemic therapy. This research is significant as it provides real-world insights into the drug’s safety among Chinese patients, potentially influencing treatment protocols and patient outcomes.
Study Overview: Amgen Inc. is conducting a study titled ‘A Rollover Study of Sotorasib With or Without Panitumumab for the Treatment of Cancer Subjects With KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study.’ The study aims to evaluate the safety and tolerability of sotorasib, alone or in combination with panitumumab, in patients with advanced solid tumors who have previously benefited from Amgen-sponsored protocols. This study is significant as it explores continued treatment options for patients with specific genetic mutations in cancer.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV)'. The study aims to assess the efficacy of avacopan, a drug intended to treat children with ANCA-associated vasculitis, a rare autoimmune disease.
Amgen Inc. is currently conducting a Phase 2 clinical study titled A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma. The study aims to evaluate the efficacy of rocatinlimab in reducing asthma exacerbations, a significant concern for individuals with moderate-to-severe asthma.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State (HZNP-DAZ-303)’. The study aims to assess the impact of dazodalibep on patient-reported symptoms and outcomes in individuals with Sjögren’s Syndrome, a condition characterized by dry eyes and mouth, among other symptoms. The significance of this study lies in its potential to improve the quality of life for patients with moderate-to-severe symptoms.
Amgen Inc., in collaboration with BeiGene, is conducting a Phase 1/2 clinical study titled ‘A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL.’ The study aims to evaluate the safety, efficacy, and pharmacokinetics of subcutaneous blinatumomab in treating R/R B-ALL and MRD+ B-ALL, which are challenging forms of leukemia.
Amgen Inc. is spearheading a clinical study titled ‘A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)’. The study aims to evaluate the safety and efficacy of subcutaneous blinatumomab in children under 12 years old with these conditions, potentially offering a significant advancement in pediatric leukemia treatment.
Amgen Inc. is currently conducting a clinical study titled ‘A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity’. The study aims to assess the safety and tolerability of AMG 513, a potential treatment for cardiometabolic disease, in individuals with obesity.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease.’ The study aims to demonstrate the superiority of maridebart cafraglutide over a placebo in reducing body weight by at least 5% among participants with obesity.
Amgen Inc. is conducting a clinical study titled A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease. The study aims to evaluate the safety and efficacy of AMG 732, a potential treatment for Thyroid Eye Disease (TED), in both healthy participants and those with the condition.
Amgen Inc. is conducting a Phase 1b clinical study titled ‘Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer.’ The study aims to assess the safety, tolerability, and feasibility of administering Xaluritamig before radical prostatectomy in patients with newly diagnosed localized intermediate or high-risk prostate cancer. This research is significant as it explores potential improvements in pre-surgical treatment options for prostate cancer.
Amgen Inc. is conducting a postmarketing prospective cohort study titled A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients. The study aims to assess the risk of herpetic infection and long-term safety in melanoma patients treated with IMLYGIC® (Talimogene Laherparepvec), as well as among their close contacts and healthcare providers.
Amgen Inc. is conducting an observational study titled An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy. The study aims to monitor the safety of UPLIZNA exposure during pregnancy in women with NMOSD, collecting data on pregnancy outcomes and related factors. This research is significant as it addresses the safety concerns of using UPLIZNA during pregnancy, potentially influencing treatment protocols for pregnant women with NMOSD.
Amgen Inc. is conducting a Phase 1 clinical study titled ‘A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AMG 378 in Healthy Participants.’ The study aims to assess the safety and tolerability of AMG 378, a new drug, in healthy volunteers. This research is significant as it lays the groundwork for future studies that could lead to new therapeutic options.
Amgen Inc. has announced a new clinical study titled A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG). The study aims to understand how inebilizumab, a drug administered intravenously, behaves in the body and its effects on children with gMG. This research is crucial as it focuses on a pediatric population, which is often underrepresented in clinical trials.
Amgen Inc., in collaboration with Asher Biotherapeutics, Inc., is launching a Phase 1b clinical study titled A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311). The study aims to assess the safety and tolerability of combining tarlatamab with AB248, focusing on determining the optimal dosage for further trials. This research is significant as it explores potential new treatment avenues for extensive stage small cell lung cancer, a challenging condition to treat.
Amgen Inc. is currently conducting a Phase 2 study titled A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma. The primary goal of this study is to evaluate the effectiveness of rocatinlimab in reducing asthma exacerbations, a significant concern for individuals with moderate-to-severe asthma.
Amgen Inc. is currently conducting a clinical study titled ‘A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).’ The study aims to assess the safety and effectiveness of bemarituzumab when used alongside other cancer treatments, specifically focusing on its combination with S-1, oxaliplatin, and nivolumab. This research is significant as it explores potential new treatment avenues for advanced gastric cancer, a condition with limited therapeutic options.
The clinical study titled A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) aims to assess the safety and effectiveness of AMG 193, a MTA-cooperative PRMT5 inhibitor. This study focuses on patients with advanced thoracic tumors characterized by MTAP deletion, a genetic alteration. The study’s significance lies in its potential to offer new treatment options for these patients.
Amgen Inc. is conducting a long-term extension study titled ‘A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren’s Syndrome (SS)’. The study aims to assess the long-term safety and tolerability of the drug dazodalibep, which is significant for advancing treatment options for patients with Sjögren’s Syndrome.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)’. The study aims to compare the progression-free survival and overall survival of patients treated with sotorasib combined with platinum doublet chemotherapy versus those treated with pembrolizumab with the same chemotherapy regimen. This research is significant as it targets patients with specific genetic markers, potentially leading to more effective personalized treatment options.
Amgen Inc. is conducting a Phase 2 study titled A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome. The study aims to assess the effectiveness and safety of the drug HZN-1116 in treating Sjögren’s Syndrome, a chronic autoimmune condition. This research is significant as it targets both systemic disease activity and subjective symptoms in affected individuals.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)’. The study aims to evaluate the efficacy of combining tarlatamab with durvalumab compared to durvalumab alone in extending overall survival in patients with extensive-stage small-cell lung cancer (ES-SCLC).
Amgen Inc. is currently conducting a Phase 2 study titled ‘A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)’. The study aims to assess the safety and efficacy of AMG 193, a drug designed to treat advanced NSCLC with MTAP deletions, a condition with limited treatment options.
Amgen Inc. and AstraZeneca have initiated a Phase 3 clinical study titled ‘A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)’. The study aims to evaluate the efficacy of adding tarlatamab to the existing treatment regimen of durvalumab, carboplatin, and etoposide, with a focus on improving overall survival rates in patients with untreated extensive stage small-cell lung cancer.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State (HZNP-DAZ-303)’. The study aims to assess the impact of dazodalibep on symptoms reported by patients with Sjögren’s Syndrome (SS), focusing on both efficacy and safety. This research is significant as it targets a condition with limited treatment options, potentially offering new hope for patients.
Amgen Inc. is conducting a Phase 4 clinical trial titled ‘A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis.’ The study aims to assess the long-term safety of avacopan, a treatment for ANCA-associated vasculitis, a serious autoimmune disease.
Amgen Inc. is currently recruiting participants for a Phase 2 study titled ‘A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)’. The primary objective is to evaluate the antitumor activity of Tarlatamab in patients with SCLC, aiming to provide insights into effective dosing regimens.
Amgen Inc., in collaboration with Asher Biotherapeutics, is initiating a Phase 1b clinical study titled ‘A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311).’ The study aims to assess the safety, tolerability, and pharmacokinetics of the drug combination, with a focus on determining the maximum tolerated dose of AB248 when used with Tarlatamab. This research is significant as it explores potential new treatment avenues for extensive stage small cell lung cancer, a condition with limited therapeutic options.
Amgen Inc. is conducting a Phase 3 clinical study titled A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator’s Choice for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation. The study aims to compare progression-free survival in patients with KRAS p.G12C mutated colorectal cancer, testing combinations of sotorasib and panitumumab against standard treatments.
Amgen Inc. recently completed a significant clinical study titled A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke. The study aimed to assess the effect of evolocumab, a cholesterol-lowering drug, on major cardiovascular events in adults at high risk but without a prior heart attack or stroke. This research is crucial as it explores preventive measures for cardiovascular diseases in high-risk populations.
Amgen Inc. is conducting a Phase 2 study titled ‘A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma.’ The study aims to evaluate the effectiveness of rocatinlimab in reducing asthma exacerbations, a significant concern for patients with moderate-to-severe asthma.
Study Overview: Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)’. The primary goal is to evaluate the long-term safety and tolerability of Rocatinlimab in treating moderate-to-severe atopic dermatitis, a significant concern for affected individuals.
Amgen Inc. is conducting a pivotal study titled ‘PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer.’ The study aims to assess the effectiveness of romiplostim in managing chemotherapy-induced thrombocytopenia (CIT), focusing on enabling timely and full-dose chemotherapy administration in patients with NSCLC, ovarian cancer, or breast cancer.
Amgen Inc. is conducting a Phase 1b clinical study titled ‘AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol).’ The study aims to determine the maximum tolerated dose and safety profile of AMG 193, a PRMT5 inhibitor, in combination with other therapies for patients with advanced MTAP-deleted thoracic tumors. This research is significant as it explores new treatment avenues for a challenging cancer subtype.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis.’ The study aims to evaluate the safety and tolerability of the drug Apremilast in children with mild to moderate plaque psoriasis, marking a significant step in expanding treatment options for this demographic.
Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)’. The study aims to assess whether maridebart cafraglutide can reduce heart failure events and improve symptoms in patients with heart failure and obesity.
Amgen Inc. is conducting a long-term extension study titled ‘A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren’s Syndrome (SS).’ The primary goal is to assess the long-term safety and tolerability of dazodalibep, a drug aimed at treating Sjögren’s Syndrome, a chronic autoimmune condition. This study is significant as it could lead to new treatment options for SS patients, enhancing their quality of life.
Amgen Inc. and AstraZeneca have initiated a Phase 3 clinical study titled ‘A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312).’ This study aims to evaluate the efficacy of adding tarlatamab to the existing treatment regimen of durvalumab, carboplatin, and etoposide in improving overall survival for patients with extensive stage small-cell lung cancer (ES-SCLC).
Study Overview: Amgen Inc. is conducting a Phase 3 study titled A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity. The study aims to demonstrate the superiority of maridebart cafraglutide over placebo in reducing cardiovascular morbidity and mortality when used alongside standard care.
Amgen Inc. is conducting a Phase 3 study titled ‘Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2).’ The study aims to demonstrate that maridebart cafraglutide is more effective than a placebo in reducing body weight among adults with type 2 diabetes who are either obese or overweight. This research is significant as it targets a prevalent health issue, offering potential new treatment options.
Amgen Inc. is conducting a Phase 2 clinical study titled A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC). The study aims to assess the safety and effectiveness of AMG 193, a drug designed to treat advanced NSCLC with MTAP deletion, a genetic alteration found in certain cancer cells.
Study Overview: Amgen Inc. is conducting a study titled A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy. The study aims to demonstrate the pharmacokinetic similarity between ABP 234 and pembrolizumab, which is significant for establishing ABP 234 as a potential alternative treatment option.
Study Overview: Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight.’ The study aims to prove that maridebart cafraglutide can lead to a greater reduction in body weight compared to a placebo. This research is significant as it targets weight management in individuals without Type 2 Diabetes, potentially offering a new treatment avenue.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202).’ The study aims to compare progression-free survival and overall survival between two treatment groups: one receiving sotorasib with platinum doublet chemotherapy and the other receiving pembrolizumab with platinum doublet chemotherapy.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies.’ The study aims to evaluate the effectiveness of rocatinlimab in reducing pruritus and improving overall clinical assessment scores in patients with prurigo nodularis.
Amgen Inc. is conducting a study titled A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis. The study aims to demonstrate the pharmacokinetic and pharmacodynamic similarities between ABP 692 and Ocrelizumab, focusing on the suppression of new active brain lesions over 24 weeks.
Amgen Inc. is conducting a study titled ‘A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma.’ The study aims to evaluate the effectiveness, safety, and immune response of ABP 206 compared to Nivolumab in patients who have not received prior treatment for their melanoma, highlighting its potential significance in advancing cancer treatment options.
Amgen Inc. is conducting a study titled A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer. The study aims to evaluate the effectiveness of ABP 234 compared to the established treatment, Keytruda®, in treating advanced lung cancer, which is significant for developing alternative therapies.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘Golden Gate Study’ to evaluate the efficacy and safety of Blinatumomab alternating with low-intensity chemotherapy compared to standard chemotherapy in older adults with newly diagnosed Philadelphia-negative B-cell precursor acute lymphoblastic leukemia. The study aims to assess event-free survival and overall survival outcomes.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)’. The study aims to evaluate the efficacy of combining tarlatamab with durvalumab versus using durvalumab alone to improve overall survival in patients with extensive-stage small-cell lung cancer (ES-SCLC).
Amgen Inc. is conducting a clinical study titled ‘A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors.’ The study aims to assess the safety and effectiveness of AMG 193, alone and with docetaxel, in treating advanced MTAP-null solid tumors. This research is significant as it targets a specific genetic mutation, potentially offering new treatment options for patients with limited alternatives.
Study Overview: Amgen Inc. is conducting a Phase 3 clinical trial titled A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy. The study aims to evaluate the efficacy of tarlatamab in improving progression-free survival in patients with LS-SCLC, highlighting its potential significance in enhancing treatment outcomes for this challenging cancer type.
Amgen Inc. is conducting a Phase 4 clinical trial titled ‘A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis.’ The study aims to assess the long-term safety of avacopan, a treatment for ANCA-associated vasculitis, a serious autoimmune disease. The significance of this study lies in its potential to provide a safer, more effective treatment option for patients.
Amgen Inc. is currently conducting a Phase 2 study titled A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren’s Syndrome. The study aims to assess the efficacy and safety of the drug HZN-1116 in treating Sjögren’s Syndrome, a chronic autoimmune disease. This research is significant as it targets improving the quality of life for patients with moderate to severe symptoms.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.' The study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of etelcalcetide in treating secondary hyperparathyroidism in pediatric patients with chronic kidney disease on hemodialysis. This study is significant as it addresses a critical need in pediatric nephrology.
Amgen Inc. is conducting a Phase 3 study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State.’ The study aims to assess the impact of dazodalibep on symptoms and patient-reported outcomes in individuals with Sjögren’s Syndrome, a condition characterized by dry mouth and eyes, among other symptoms. The research is significant as it seeks to provide a new treatment option for those suffering from this chronic autoimmune disease.
Amgen Inc. is currently conducting a Phase 3 study titled Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis. The study aims to evaluate the efficacy and safety of Etelcalcetide in treating secondary hyperparathyroidism (SHPT) in pediatric patients on hemodialysis, addressing a significant unmet medical need in this population.
Amgen Inc. recently updated its clinical study titled ‘A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation.’ The study aims to provide expanded access to Sotorasib and assess its safety for patients with specific non-small-cell lung cancer mutations, highlighting its significance in offering real-world treatment options.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis.’ The study aims to evaluate the efficacy and safety of the drug apremilast in treating moderate to severe plaque psoriasis in Japanese children and adolescents aged 6 to 17 years.
Amgen Inc. is currently recruiting for a Phase 2a clinical study titled A Phase 2a, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases. The study aims to evaluate the safety and tolerability of inebilizumab and blinatumomab in adults with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), conditions that are notoriously challenging to treat. This research is significant as it targets refractory cases, potentially offering new hope for patients with limited treatment options.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta.’ The study aims to assess the efficacy and safety of Romosozumab, a drug administered via subcutaneous injection, compared to standard bisphosphonate treatments. The primary focus is on reducing clinical fractures and improving bone mineral density in children and adolescents with Osteogenesis Imperfecta.
Amgen Inc. is conducting a Phase 3 clinical study titled A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND). The study aims to evaluate the long-term safety and tolerability of rocatinlimab in patients with moderate-to-severe atopic dermatitis, a chronic skin condition that significantly impacts quality of life.
Amgen Inc. is currently recruiting participants for a Phase 3 clinical study titled ‘A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)’. The study aims to compare progression-free survival and overall survival between two treatment groups, highlighting its significance in advancing treatment options for this type of lung cancer.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV).' The study aims to assess the efficacy of avacopan in treating children with AAV, a rare autoimmune disease, highlighting its potential significance in pediatric care.
Amgen Inc and AstraZeneca have announced a new clinical study titled A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON). This study aims to evaluate the efficacy and safety of tezepelumab, a potential treatment for pediatric patients with severe uncontrolled asthma, highlighting its significance in addressing unmet medical needs in this demographic.
Amgen Inc. is conducting a Phase 2 study titled ‘A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)’. The study aims to assess the safety and efficacy of AMG 193, a drug intended for patients with MTAP-deleted advanced NSCLC, a condition with limited treatment options.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)’. The study aims to evaluate the efficacy of combining tarlatamab with durvalumab compared to using durvalumab alone in improving overall survival for patients with extensive-stage small-cell lung cancer (ES-SCLC).
Study Overview: Amgen Inc. is conducting a Phase 3 study titled A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity. The study aims to demonstrate that maridebart cafraglutide is more effective than a placebo in reducing cardiovascular morbidity and mortality when used alongside standard care in patients with atherosclerotic cardiovascular disease and obesity. This study is significant as it targets a major health concern, potentially offering a new treatment avenue.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)’. The study aims to demonstrate the superiority of maridebart cafraglutide over a placebo in reducing body weight among adults with type 2 diabetes who are overweight or obese.
Amgen Inc. is currently conducting a Phase 3 study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State.’ The study aims to assess the impact of dazodalibep on patient-reported symptoms and outcomes in individuals with moderate-to-severe Sjögren’s Syndrome, as well as its safety and tolerability.
Amgen Inc. is currently conducting a Phase 3 clinical study titled ‘Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease.’ The study aims to evaluate the effectiveness, safety, and tolerability of maridebart cafraglutide compared to a placebo in reducing body weight among adults with obesity in Japan. The primary objective is to demonstrate the drug’s superiority over placebo in achieving significant weight loss.
Amgen Inc. is conducting a clinical study titled A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma. The study aims to assess the effectiveness and safety of ABP 206, a new drug, compared to Nivolumab in patients with advanced melanoma. This research is significant as it could offer a new treatment option for this challenging condition.
Amgen Inc. is conducting a clinical study titled ‘A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer.’ The study aims to assess the efficacy of ABP 234 compared to the widely used pembrolizumab in treating advanced non-squamous non-small cell lung cancer. This research holds significant potential for enhancing treatment options for this severe condition.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-severe Systemic Disease Activity.’ The study aims to assess the impact of dazodalibep on systemic manifestations of Sjögren’s Syndrome (SS) and its effect on patient-reported outcomes, alongside evaluating the drug’s safety and tolerability.
Amgen’s Q2 FY 2025 earnings call conveyed a positive sentiment, underscored by robust financial performance and promising pipeline developments. Despite some challenges, such as a decline in Prolia sales and increased R&D expenses, the overall outlook remains optimistic due to significant revenue and volume growth driven by key products and biosimilars.
Amgen Inc., a leading biotechnology company, specializes in developing innovative medicines for serious diseases, including cancer, heart disease, and rare conditions. In its recent earnings report for the second quarter of 2025, Amgen announced a 9% increase in total revenues, reaching $9.2 billion, with product sales also growing by 9%. The company’s GAAP earnings per share saw a significant rise of 92%, driven by increased revenues, while non-GAAP EPS rose by 21%. Key products such as Repatha and EVENITY showed strong double-digit sales growth, and the company continued to invest in its research and development programs, including the promising MariTide studies. Looking ahead, Amgen remains focused on sustainable, long-term growth, with a projected revenue range of $35.0 billion to $36.0 billion for the full year 2025, and continued investment in its robust pipeline of innovative treatments.