Amarin Corporation plc announced positive post-hoc analysis results from the VASCEPA/VAZKEPA study, demonstrating a significant reduction in ischemic events for patients with recent acute coronary syndrome (ACS). The analysis, presented at the ACC.23/WCC, revealed that icosapent ethyl reduces the risk of first and total ischemic events by 37% and 36%, respectively, without increasing bleeding rates. The findings support early treatment initiation after ACS.

Esperion announced significant outcomes from the CLEAR Outcomes trial, showcasing NEXLETOL's effectiveness in reducing major adverse cardiovascular events (MACE) by 13% to 15% compared to placebo, and by 23% to 19% for myocardial infarction and coronary revascularization, respectively. The study results were published in the New England Journal of Medicine and presented at the ACC.23/WCC. Esperion anticipates regulatory filings in Q1 2023 and expects significant milestone payments based on the inclusion of cardiovascular risk reduction data.

Esperion announced that the results of the CLEAR Outcomes trial, focusing on cholesterol lowering via Bempedoic acid, will be presented at the American College of Cardiology’s Annual Scientific Session. Sheldon Koenig, CEO of Esperion, expressed enthusiasm for sharing detailed data from the trial, which aims to demonstrate significant cardiovascular risk reduction through NEXLETOL.

PLx Pharma experienced a significant decline in Q3 revenue, falling 94.1% year-over-year, resulting in a revenue of $0.39 million compared to $6.6 million in the same quarter last year. The company reported an operating loss of $10.84 million, an increase from a loss of $9.86 million the previous year, and had a GAAP EPS of -$0.30, up from -$0.80 in the 2021 quarter.

A committee of the European Medicines Agency (EMA) recommended the expanded approval of Sanofi's heart disease therapies Iscover and Plavix, as well as DuoPlavin, which also includes clopidogrel and acetylsalicylic acid. The EMA's Committee for Medicinal Products for Human Use (CHMP) altered the indications for Iscover and Plavix to include secondary prevention of atherothrombotic events in patients with ST segment elevation acute myocardial infarction undergoing percutaneous coronary intervention (PCI). The European Commission will now decide on the change to the marketing authorization terms.