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 American Diabetes Association (ADA) issued posiitive updates following the results of the REDUCE-IT cardiovascular outcomes study.
Of course, the update led to excitement among investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The ADA update;
- what we’re seeing from AMRN stock as a result; and
- what we’ll be watching for ahead.
AMRN Stock Gains On ADA Update
As mentioned above Amarin Corporation is having an incredibly strong start to the trading session this morning after the ADA issued a positive update surrounding Vascepa. The update came following the results of the REDUCE-IT cardiovascular outcomes trial.
The update was provided through newly published research, covering the REDUCE-IT results, and was approved by the ADA’s Professional Practice Committee. This committee is responsible for producing the annual Standards of Care. The Standards of Care update referenced the active ingredient in Vascepa (icosapent ethyl) capsules.
AMRN reminded investors that Vascepa is currently approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Moreover, the company has commenced the transmission of data to the FDA to support the submission of a supplemental New Drug Application (sNDA).
The sNDA is seeking an expansion of the Vascepa FDA label based on the REDUCE-IT trial results. The company said that the ADA does not provide endorsements or any form of certification for brand name commercial products as a general policy of the organization. As a result, the inclusion of icosapent ethyl in ADA’s Standards of Care should not be understood as an endorsement or approval by the ADA of Vascepa.
Nonetheless, based on the results of the REDUCE-IT study, in both primary and secondary prevention populations, the Living Standards of Care now include the recommendation that icosapent ethyl:
…be considered for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with controlled low-density cholesterol (LDL-C), but with elevated triglycerides (135-499) to reduce cardiovascular risk.
The ADA also said that the updated finding was:
…based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events.
The ADA standards also reiterate that:
It should be noted that data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products.
Cardiovascular disease is the leading cause of morbidity and mortality for individuals with diabetes, and cardiovascular disease is the cause of one in three deaths in the U.S. The ADA added that:
Recently published research indicated an urgent need to update the 2019 Standards of Care to ensure optimal treatment recommendations for people with cardiovascular disease and diabetes.
As a result, the AMRN said that the findings were made with a level “A” grade of scientific evidence. As a result, according to ADA standards, the REDUCE-IT trial was considered to be a large, well-designed clinical trial. It’s also worth mentioning that A-level recommendations are only given to treatments that the ADA believes has the best chance of improving outcomes when applied to the population to which tye are appropriate.
In a statement, Craig B. Granowitz, M.D., Ph.D., SVP and CMO at AMRN, had the following to offer:
As we have commenced transmission of data to the FDA for the submission of our sNDA seeking an expansion of the Vascepa label based on the landmark REDUCE-IT results, we are pleased by ADA’s acknowledgement of the importance of the REDUCE-IT results in its 2019 update of the Standards of Care.
The medical community will also hopefully take note of recent research reporting the prevalence of, and increased costs associated with, diabetes mellitus and high triglyceride levels despite statin therapy5.
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 Corporation, the news proved to be overwhelmingly positive.
After all, while the ADA does not endorse any brand name product, it did outline that the active ingredient in Vascepa has tremendous medical power. So, it’s not surprising to see that excited investors are pushing the stock up.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:49), AMRN is trading at $18.88 per share after a gain of $0.80 per share or 4.42% 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 the masses as the REDUCE-IT data and further validation by the ADA show that the treatment has tremendous potential. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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