Amarin Corporation (NASDAQ:AMRN) is having a great day in the market today after a big ruling from a United States District Court in a conflict between the company and the FDA. Today, we’ll discuss what that ruling is, how it’s affecting the stock today, what it means for AMRN, and what we can expect from the stock moving forward. So, let’s get right to it…
District Court Rules That AMRN Can Tell Doctors Of Unapproved Benefits
Amarin and the FDA have been in the midst of a battle with regard to the advertisement of unapproved uses of the company’s lead drug, Vascepa. The court ruled that Amarin can inform medical professionals of benefits associated with Vascepa that are currently unapproved by the FDA as long as the promotion is “truthful and non-misleading”. This information includes FDA-reviewed and agreed effects of Vescepa that have been demonstrated in the ANCHOR clinical trial of patients with persistently high triglycerides after statin therapy. Ultimately, as a result of the ruling, Amarin can inform doctors of the current state of scientific research that is related to the potential of Vescepa to reduce the risk of cardiovascular disease in patients described above. Following the ruling, John F. Thero, CEO of AMRN had the following to say…
“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients… Many physicians are aware of the efficacy data including in FDA-approved labeling for Vescepa but are not aware of efficacy data from the ANCHOR study of Vascepa. FDA has already included the safety data from both the MARINE and ANCHOR studies in approved Vascepa labeling. Amarin will now be able to communicate efficacy data from ANCHOR and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers.”
How Amarin Stock Reacted To The News
As mentioned above, Amarin is having a great day in the market today. The bottom line is that when positive information is made available, we tend to see gains; and that’s exactly what we’re seeing today. Currently (12:53), AMRN is trading at $2.32 per share after a gain of 13.73% so far today.
What We Can Expect To See Moving Forward
Moving forward, I’m expecting to see a continuation of bullish activity. The reality is that anyone who has followed Vascepa trials knows that the drug knows that the drug has the potential to reduce the risk of cardiovascular disease but that the company hasn’t had the opportunity to promote that. However, the court ruling changes this. As a result, we can expect to see Vascepa being prescribed more by physicians; ultimately leading to higher revenue and profits for Amarin. Overall, today’s news was a big win for AMRN and its investors.