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Amarin Gains on FDA Approval of Vascepa Label Expansion
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Shares of Amarin Corporation (AMRN - Free Report) gained after the company announced that the FDA approved a label expansion for Vascepa.
Vascepa is now approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
The approval was based on the results of the REDUCE-IT cardiovascular outcomes study. Last month, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to approve the label expansion for Vascepa (icosapent ethyl) capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol).
The label expansion should significantly boost Vascepa as, per estimates, millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy. Vascepa will be a new FDA-approved treatment option to reduce the persistent cardiovascular risk faced by many patients despite the use of statins with other contemporary standard-of-care therapies.
We remind investors that the drug was initially approved by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Amarin will launch the drug in the United States immediately, given its strong sales force, which it had doubled toward the beginning of 2019. It will double the size of its sales force again to a total of 800 sales representatives in the beginning of 2020. We expect the initial uptake of the drug to be strong and boost the top line, given the market potential.
Shares of Amarin have soared 77.2% so far this year compared with the industry's growth of 7.2%.
Concurrently, Amarin updated its guidance for 2019 and issued the same for 2020. The company now expects net revenues of $410-$425 million compared to the earlier estimated range of $380-$420 million.
For 2020, Amarin projects total net revenues of $650-$700 million, mostly from sales of Vascepa in the United States.
Earlier this month, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) seeking approval of Vascepa as a treatment to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment but have elevated triglycerides, 135 mg/dL or above, and other cardiovascular risk factors.
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Amarin Gains on FDA Approval of Vascepa Label Expansion
Shares of Amarin Corporation (AMRN - Free Report) gained after the company announced that the FDA approved a label expansion for Vascepa.
Vascepa is now approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
The approval was based on the results of the REDUCE-IT cardiovascular outcomes study. Last month, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to approve the label expansion for Vascepa (icosapent ethyl) capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol).
The label expansion should significantly boost Vascepa as, per estimates, millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy. Vascepa will be a new FDA-approved treatment option to reduce the persistent cardiovascular risk faced by many patients despite the use of statins with other contemporary standard-of-care therapies.
We remind investors that the drug was initially approved by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Amarin will launch the drug in the United States immediately, given its strong sales force, which it had doubled toward the beginning of 2019. It will double the size of its sales force again to a total of 800 sales representatives in the beginning of 2020. We expect the initial uptake of the drug to be strong and boost the top line, given the market potential.
Shares of Amarin have soared 77.2% so far this year compared with the industry's growth of 7.2%.
Concurrently, Amarin updated its guidance for 2019 and issued the same for 2020. The company now expects net revenues of $410-$425 million compared to the earlier estimated range of $380-$420 million.
For 2020, Amarin projects total net revenues of $650-$700 million, mostly from sales of Vascepa in the United States.
Earlier this month, the European Medicines Agency (EMA) validated the marketing authorization application (MAA) seeking approval of Vascepa as a treatment to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment but have elevated triglycerides, 135 mg/dL or above, and other cardiovascular risk factors.
Key players in this space are Sanofi (SNY - Free Report) /Regeneron (REGN - Free Report) ’s Praluent and Amgen’s (AMGN - Free Report) Repatha.
Amarin is currently a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
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This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
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