AMGEN INC

Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024.

Products/Pipeline

Repatha

In August 2025, we announced that the FDA broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement that a patient have been diagnosed with cardiovascular (CV) disease.

In November 2025, we announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha achieved statistically significant and clinically meaningful reductions in MACEs in high-risk adults without a prior heart attack or stroke, when added to statins or other LDL-C–lowering treatments. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a cohort of patients included in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm. No new safety signals were identified, and tolerability was consistent with the current prescribing information in the United States.

UPLIZNA

In April 2025, we announced the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients. UPLIZNA is the first and only FDA approved treatment for adults living with IgG4-RD.

In December 2025, we announced the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

IMDELLTRA/IMDYLLTRA

In June 2025, we announced interim results from the global Phase 3 DeLLphi-304 trial evaluating IMDELLTRA/IMDYLLTRA in patients with small cell lung cancer (SCLC) who had progressed on or after one line of platinum-based chemotherapy. The study demonstrated that IMDELLTRA/IMDYLLTRA significantly reduced the risk of death by 40% compared to standard-of-care chemotherapy, with a median overall survival of 13.6 months compared to 8.3 months. Additionally, IMDELLTRA/IMDYLLTRA showed a statistically significant improvement in median progression-free survival of 4.2 months compared to 3.7 months and enhanced patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough. The safety profile of IMDELLTRA/IMDYLLTRA was consistent with prior studies.

In November 2025, we announced that the FDA granted full approval for IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy, converting its prior accelerated approval to full approval based on results from the global Phase 3 DeLLphi-304 study.

In October 2025, we announced that the FDA approved TEZSPIRE as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

TEPEZZA

In June 2025, the European Commission granted marketing authorization approval of TEPEZZA for treatment of adults with moderate-to-severe thyroid eye disease (TED).

Maridebart cafraglutide (MariTide™)

In March 2025, we announced the initiation of two global Phase 3 studies to evaluate MariTide, a differentiated antibody-peptide conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR), in chronic weight management: one study in adults living with obesity or overweight without Type 2 diabetes and another study in adults living with obesity or overweight with Type 2 diabetes.

In June 2025, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85 th Scientific Sessions and simultaneously published in The New England Journal of Medicine.

In November 2025, we announced that, in addition to the two global Phase 3 studies announced in March 2025, four global Phase 3 studies were underway, with studies in adults living with established atherosclerotic cardiovascular disease and obesity or overweight; in adults living with heart failure with preserved or mildly reduced ejection fraction and obesity; in adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight; and in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.

In January 2026, we announced that Part 2 of the Phase 2 chronic weight management study, an exploratory evaluation of MariTide treatment for an additional 52 weeks in people who lost at least 15% of their body weight in the 52-week Part 1 of the Phase 2 chronic weight management study, is complete. Key findings included the following: the large majority of participants maintained the weight loss achieved in Part 1 for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide; the second year of MariTide treatment was very well tolerated, including at quarterly doses, with a very low incidence of nausea and vomiting and no new safety signals observed; and improvements in cardiometabolic parameters were sustained with MariTide at effective maintenance doses for a full second year.

In January 2026 we also announced that a Phase 2 study of MariTide for the treatment of Type 2 diabetes in adults living with and without obesity has completed the 24-week timepoint. Key findings included the following: robust and clinically meaningful reduction in both hemoglobin A1c (HbA1c) and weight with monthly MariTide at 24 weeks, which is in line with results seen in the Type 2 diabetes population in Part 1 of the Phase 2 chronic weight management study, at 24 weeks; safety and tolerability profile consistent with the GLP-1 class, where the most common side effects were gastrointestinal-related, predominantly mild-to-moderate in nature, and occurred primarily during dose escalation; and favorable improvement in cardiometabolic parameters.

TAVNEOS

TAVNEOS was approved by the FDA in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids. TAVNEOS was developed by ChemoCentryx. Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year. On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market. The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial. Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine. Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial, and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market. Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront.

Bemarituzumab

In February 2026, we announced that, based upon data from the FORTITUDE-101 and FORTITUDE-102 Phase 3 studies, the Company does not intend to pursue regulatory approval of bemarituzumab in first-line gastric cancer.

Rocatinlimab

In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the

Hart-Scott-Rodino Antitrust Improvements Act of 1976. In February 2026, we received such regulatory clearance. In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.