Detailed Narrative
MariTide Clinical Development Progress
The MariTide Phase III program is rapidly advancing, with chronic weight management studies fully enrolled and ASCVD and heart failure outcome studies progressing well. Amgen has initiated two Phase III sleep apnea studies, bringing the total to six global Phase III studies. Results from completed Phase II chronic weight management and type 2 diabetes studies further increase confidence in MariTide's potential for obesity and related conditions, offering strong efficacy and favorable tolerability with monthly or less frequent dosing.
Repatha Landmark VESALIUS-CV Trial Results
Full results from the Phase III VESALIUS-CV trial for Repatha were presented, demonstrating a 25% relative risk reduction in the composite of coronary heart disease death, heart attack, or ischemic stroke, and a 36% reduction in heart attack. These data, observed in over 12,000 patients without prior events over ~4.5 years, reinforce Repatha's role in earlier and intensive LDL-cholesterol management for both primary and secondary prevention, with no new safety signals observed.
UPLIZNA Regulatory Approvals and Pipeline Expansion
UPLIZNA received European Commission approval for IgG4-related disease in November 2025 and FDA approval for generalized myasthenia gravis in December 2025. These approvals are supported by strong Phase III data showing durable efficacy and a steroid-sparing benefit with twice-yearly dosing. Amgen plans to initiate two pivotal studies in 2026 for autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy (CIDP), leveraging UPLIZNA's CD19-directed B-cell depletion mechanism.
Oncology Portfolio and Pipeline Updates
Amgen's innovative oncology portfolio grew 11% in 2025, driven by BiTE medicines like IMDELLTRA, which received full FDA approval for extensive-stage small cell lung cancer and is becoming a standard of care. BLINCYTO also saw significant growth, up 28% to over $1.5 billion. The company is advancing IMDELLTRA in combination therapy for front-line extensive-stage small cell and in a Phase III study for limited-stage small cell lung cancer, alongside xaluritamig in prostate cancer and Ewing sarcoma.
Biosimilars Portfolio Growth and Future Wave
The biosimilars portfolio contributed over $13 billion in sales since 2018, with 2025 sales reaching $3 billion, a 37% increase. PAVBLU, a biosimilar to EYLEA, gained momentum with $700 million in sales in 2025. Amgen is preparing for the next wave of biosimilar launches, with ABP 206 (Opdivo biosimilar) and ABP 234 (Keytruda biosimilar) having completed enrollment in their comparative clinical studies.
Portfolio Prioritization and Asset Decisions
Amgen made portfolio decisions to focus resources on late-stage programs, terminating the rocatinlimab development and commercialization collaboration with Kyowa Kirin. Additionally, the company decided not to pursue regulatory approval for bemarituzumab in first-line gastric cancer, despite observing an emerging signal of putative survival benefit in a biomarker-defined patient subset, as overall efficacy did not meet expectations.
TAVNEOS Regulatory Dialogue and Daxdilimab Phase II Data
Amgen is engaged in ongoing dialogue with the FDA regarding TAVNEOS following a voluntary withdrawal request on January 16, 2026, related to concerns over re-adjudication of primary endpoint results for 9 patients in the ADVOCATE study. Separately, positive Phase II data for daxdilimab in primary discoid lupus erythematosus were announced, meeting primary and key secondary endpoints with an attractive safety profile, prompting advancement to the next phase of development.