Amarin Corporation plc (NASDAQ: AMRN) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that the FDA has granted priority review, exciting investors and sending the stock for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from AMRN stock as a result; and
- what we’ll be watching for ahead.
AMRN Announces Priority Review
As mentioned above, Amarin Corporation is having a great start to the day in the market today after announcing a regulatory update. The update came by way of press release early this morning.
In the release, the comapny said that its supplemental New Drug Application (sNDA) for Vascepa has been accepted for filing and granted Priority Review designation by the FDA. As a result of the Priority Review status, it is expected that the FDA will make a decision by no later than September 28, 2019.
This is a big deal for AMRN. After all, if approved, the treatment will be the only drug on the market that is indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides. At the moment, this is a serious health challenge experienced by millions. Moreover, with the AHA no longer recommending daily baby aspirin, there are no realistic options for treatment. So, should the sNDA be approved, it could turn Vascepa into a blockbuster drug.
In a statement, John F. Thero, President and CEO at AMRN, had the following to offer:
We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy.
These patients will be the focus of our planned expanded REDUCE-ITTM promotional efforts. We are very pleased that the FDA has accepted our application and granted it priority review. We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the United States. Our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming PDUFA date.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Amarin, the news proved to be overwhelmingly positive.
After all, should Vascepa be approved for the supplemental indication, the treatment could prove to be a blockbuster, offering millions of patients an option to control cardiovascular risk and offering investors incredible value. So, it’s not surprising to see that excited investors are sending the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:14), AMRN is trading at $17.95 per share after a gain of $0.94 per share or 5.53% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AMRN. In particular, we’re interested in following the story surrounding the company’s continued work to bring Vascepa to market for the reduction of cardiovascular risk as this would provide incredible value to investors. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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