Procore signs multi-year strategic collaboration agreement with AWS
THOUSAND OAKS, Calif. - The U.S. Food and Drug Administration has broadened the approved use of Amgen’s (NASDAQ:AMGN) Repatha to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL cholesterol, according to a company statement Monday. The biotech giant, with a market capitalization of $158 billion and trailing twelve-month revenue of $34.9 billion, continues to strengthen its position in the cardiovascular treatment space.
The label update removes a previous requirement that patients must have been diagnosed with cardiovascular disease before qualifying for the treatment. The FDA also expanded Repatha’s approval as a standalone therapy for patients with homozygous familial hypercholesterolemia, a rare genetic form of high cholesterol. According to InvestingPro analysis, Amgen maintains strong profitability with a 69.4% gross margin, and analysts expect continued net income growth this year. For detailed insights and additional ProTips about Amgen’s growth prospects, investors can access the comprehensive Pro Research Report.
"Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen.
The FDA emphasized that Repatha should be used alongside diet and exercise for managing high cholesterol.
Repatha is a human monoclonal antibody that works by inhibiting PCSK9, a protein that prevents the liver from removing LDL cholesterol from the blood. By blocking PCSK9, Repatha increases the liver’s ability to clear LDL cholesterol from the bloodstream.
First approved in 2015, Repatha has been used by more than 5 million people worldwide, according to the company. The drug is currently approved in more than 74 countries, including the U.S., Japan, Canada and all 28 European Union member countries.
Common side effects reported in clinical trials include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
In other recent news, Amgen has reported impressive second-quarter earnings, surpassing expectations in both revenue and earnings per share. The company achieved a revenue of $9.20 billion, exceeding the consensus estimate of $8.94 billion, driven by strong performance in its rare disease portfolio, including products like Tepezza, Krystexxa, and Uplizna. Following these results, Amgen has raised its full-year guidance. Analysts have responded with varied assessments; RBC Capital raised its price target to $330, maintaining an Outperform rating, while Bernstein SocGen lowered its target to $335 due to MariTide risk, despite keeping an Outperform rating. Cantor Fitzgerald reiterated a Neutral rating with a $305 target, citing strong sales from Evenity and Imdelltra. TD Cowen maintained a Buy rating with a $389 target, emphasizing Amgen’s growth portfolio and higher operating margins. BMO Capital also reiterated an Outperform rating with a $335 target, highlighting strong commercial execution across Amgen’s product portfolio.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.