Fiserv earnings missed by $0.61, revenue fell short of estimates
DUBLIN/BRIDGEWATER, N.J. - The U.S. Food and Drug Administration has revised the labeling for fenofibrate drugs to include a statement about their lack of cardiovascular benefit, Amarin Corporation plc (NASDAQ:AMRN) announced Monday. The company, which has seen its stock surge over 100% year-to-date according to InvestingPro data, maintains a strong financial position with more cash than debt on its balance sheet.
The updated labeling now states that fenofibrate did not reduce cardiovascular disease morbidity or mortality in two large clinical trials of patients with type 2 diabetes. It also highlights increased risk of rhabdomyolysis when fibrates are used with statins and narrows the drug’s indication to reducing elevated LDL-C in adults with primary hyperlipidemia when recommended LDL-C lowering therapies cannot be used.
The FDA’s decision follows decades of clinical evidence, including the FIELD (2005), ACCORD Lipid (2010), and PROMINENT (2022) trials, which demonstrated that fenofibrates do not reduce cardiovascular event risk, even when used alongside statins.
Despite this evidence, fibrates remain widely prescribed, with over 11 million prescriptions written in the U.S. in 2023. In Europe, they are the third most commonly used agent in lipid management after statins and ezetimibe.
"We recognize that cardiovascular disease is a complex problem that many experts are urgently working to address," said Aaron Berg, President & CEO of Amarin, according to the press release. "However, when it comes to heart health, the FDA has recognized that the science has evolved and is increasingly clear."
The labeling change was prompted by a citizen petition from HealthyWomen, an advocacy organization.
Amarin is the maker of VASCEPA (icosapent ethyl), an FDA-approved therapy for cardiovascular risk reduction in certain patients with elevated triglycerides who are also treated with statins.
In other recent news, Amarin Corporation reported its Q2 2025 earnings, showcasing a substantial revenue beat with $72.7 million, compared to the forecasted $42.55 million. This represents a significant 70.95% surprise for investors. Despite the impressive revenue figures, the company posted a loss per share of $0.03, which was notably better than the anticipated loss of $1. Additionally, Amarin presented promising in vitro data at the European Society of Cardiology Congress 2025. The data highlighted potential anti-inflammatory mechanisms of its drug VASCEPA, particularly focusing on eicosapentaenoic acid (EPA) and its role in reducing inflammation in atherosclerotic cardiovascular disease. The research emphasized EPA’s capability to modulate the NLRP3 inflammasome and reduce oxidative stress. These developments provide investors with a comprehensive look at Amarin’s recent performance and ongoing research efforts.
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