The biggest news to drop in the biotech world on Tuesday was regarding a closely watched company called Amarin (NASDAQ: AMRN). While some investors might not have heard of it, the company quickly became a hot topic among speculators when its flagship fish oil drug, which helps lower cholesterol in patients that are at risk of heart attacks and stroke, was scheduled for a FDA committee hearing to judge whether the drug should move onwards. As the markets waited in anticipation, it finally appears that the FDA committee has given a tentative thumbs up for the drug.
Shares of Amarin surged on Tuesday after the FDA released documents that suggested that the fish oil drug in question, Vascepa, had a strong benefit to risk profile for its use in patients with more severe cardiovascular disease. While the meeting is expected to take place on Thursday, the initial positive response was sufficient to send the stock soaring as the possibility of approval seems almost certain.
“The FDA has clearly taken its stance that mineral oil had minimal impact, which, in turn, likely makes it less likely the Vascepa discussion would go south on this discussion point,” wrote Leerink analyst Ami Fadia in response to the news. “What does appear [to] be the main topic of discussion is how broad a label can Vascepa potentially get.”
Chances were already quite strong that Vascepa would see approval, not just because of its strong previous clinical data that supported the drug, but also due to the fact that the majority of FDA committees end up approving drugs on a historical basis. Should the drug receive approval to be sold to a wider audience, Vascepa would likely begin being sold to this wider cardiovascular patient market sometime in late December.
At the same time, Amarin also reported strong revenues across the board. In their recent Q3 2019 financial results, the company saw product revenues grow by 104% to $112.3 million, as opposed to the $55 million seen around the same time last year. This growth was entirely fueled by the initial sales of Vascepa, which is Amarin’s only drug at the moment.
Even before this announcement, the vast majority of analysts covering the company were quite optimistic about its prospects, concurring with many speculators that odds look good for the biotech stock. This recent piece of news more than reassured any doubtful voices on Wall Street as chances for Vascepa’s approval seems almost certain.
Amarin shot up by 23.8% in response to the news, with the stock up an already 50% since the beginning of 2019. Investors and traders alike should keep their eyes peeled for AMRN on Thursday, as it’s likely that the stock will surge even more once more official remarks are released by the FDA.
Amarin Company Profile
Amarin Corp PLC is a biopharmaceutical company. It is focused on the commercialization and development of therapeutics to improve cardiovascular health. Its products include Vascepa. The firm has Development and Commercialization of Vascepa operating segment. It mainly operates in the United States. – Warrior Trading News
