Amgen Inc. (AMGN), a commercial-stage biotechnology company, reported new subgroup analyses from the phase 3 VESALIUS-CV trial of its PCSK9 inhibitor, Evolocumab (Repatha), for people living with high-risk diabetes and elevated LDL-C (Low-Density Lipoprotein Cholesterol) who have not had a prior heart attack or stroke.
Company Profile
Amgen includes a portfolio of approved products across oncology, inflammation, cardiovascular disease, bone health, and rare diseases, with a pipeline focused on clinical-stage candidates targeting a range of serious illnesses.
Repatha (Evolocumab)
Repatha, also known as Evolocumab, is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It is designed to bind circulating PCSK9, preventing it from binding to the low-density lipoprotein receptor (LDLR). This mechanism of Repatha increases LDLR availability to clear low-density lipoprotein (LDL) from the blood, thereby lowering LDL levels.
It was first approved by the U.S. Food and Drug Administration, or FDA, in 2015 and has been used since for patients globally.
In August 2025, the FDA approved expanded Repatha's indication to include adults at increased risk of major adverse cardiovascular events due to uncontrolled LDL-C. VESALIUS-CV
VESALIUS-CV is a phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to assess the impact of Repatha in lowering LDL-C on major adverse cardiovascular events (MACE) in patients at high cardiovascular risk who had no prior myocardial infarction or stroke.
The company enrolled approximately 12,000 patients with qualifying atherosclerosis (or established atherosclerotic disease) or high-risk diabetes, without prior MI or stroke.
Key Highlights
According to the phase 3 VESALIUS-CV results, from an analysis of 6,002 patients, Repatha, when administered to patients receiving statins or LDL-C-lowering therapies, reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction, or ischemic stroke (3-P MACE) by 29% compared with placebo.
The company further added that it reduced the risk of a second composite primary endpoint, which included ischemia-driven revascularization (4-P MACE), by 21%.
The median achieved LDL-C was 45 mg/dL in the Repatha arm compared to 106 mg/dL with the placebo.
Amgen has traded between $267.83 and $391.29 over the last year.
Amgen shares closed Friday at $349.58, up 1.15%. In the overnight market, shares are trading at $351.18, up 0.46%.
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