Amarin Corporation (AMRN) Stock Heads Up On FDA Approval

Amarin Corporation AMRN Stock News

Amarin Corporation plc (NASDAQ: AMRN) is having a strong start to the trading session this morning, and for good reason. The company announced that the FDA has approved its label expansion, sending the stock up more than 6% early on. Here’s what’s going on:

AMRN Stock Climbs On Cardiovascular Risk Indication Approval

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Investors in Amarin Corporation received some long-awaited positive news over the weekend. The United States FDA has approved VASCEPA as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infraction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels and established cardiovascular disease or diabetes.

In a statement, John F. Thero, President and CEO at AMRN, had the following to offer:

We at Amarin are excited and gratified to now have the opportunity to introduce VASCEPA as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies.

We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin. We look forward to helping educate physicians and patients on the value of VASCEPA. The expanded indication and related clinical study labeling is broadly worded, informative on the many effects of VASCEPA and will empower physicians with critical information to help them apply their clinical judgment in addressing cardiovascular disease risk for patients in need.

In anticipation of this approval, AMRN has made big moves that will likely allow it to hit the ground running with this new indication. In fact, the company recently doubled its sales force in 2019, bringing it to a total of around 400 sales representative this year. Moreover, the company is on track to double its sales force again to 800 representatives by the beginning of 2020.

As a result of the approval, Amarin Corporation has greatly improved its guidance. For the 2019 year, the company is expecting total net revenue to come in between $410 and $425 million. Previously, it was expected that the company would generated between $380 and $420 million in revenue this year.

Next year, AMRN is expecting substantial growth, with Vascepa revenues coming in between $650 and $700 million. Moreover, the company said that beyond 2020, it believes that total net revenues will grow to be multiple billions of dollars.

Why This Is Such A Big Deal

First and foremost, just take a look at the revenue projections. This approval could send Amarin’s revenue skyrocketing, which, of course, would be good for all involved. However, the excitement goes further than possible revenue growth.

The truth of the matter is that a short while ago, the American Heart Association and other highly regarded heart health associations announced that they no longer recommend once-daily baby aspirin as a way to mitigate risk associated with cardiovascular concerns.

Because there have been no approved medications for this indication, when this recommendation was pulled, the patient population that is addressed by Vascepa was left with no options.

With the approval, Vascepa is now not only the only FDA approved option, it’s the only widely accepted option for these patients to mitigate risk. As such, sales expectations provided by AMRN, in my view, are relatively modest as Vascepa has the potential to become a blockbuster drug!

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2 thoughts on “Amarin Corporation (AMRN) Stock Heads Up On FDA Approval”

  1. Hey Josh,
    Guess somebody forgot to tell the market about “The big deal”, unless you mean, “The Big Blow Up””!!!

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