Amarin Shares Explode Ahead of FDA Decision

Shares of Amarin climbed higher on Tuesday ahead of an FDA meeting for the company’s only drug, a prescription fish-oil derived pill called Vascepa.

The gains came on the likelihood that the U.S. Food and Drug Administration advisory committee would recommend that the regulator grant a broader indication for the company’s drug.

Amarin is seeking to expand the label to say that Vascepa can reduce cardiovascular risks, like stroke, heart attack or death.

The company’s president and CEO John Thero told investors during an earnings call last week that “millions of patients” may be helped by “the potential to use Vascepa and its cardio protective results,” according to a FactSet transcript of the call.

The FDA initially approved Vascepa in 2012 to lower triglyceride levels, which may be linked to heart problems.
Leerink analyst Ami Fadia wrote, “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. What does appear [to] be the main topic of discussion is how broad a label can Vascepa potentially get.”

Stifel analyst Derek Archila wrote last week that he anticipates fourth-quarter sales of Vascepa to be strong.

The FDA is expected to make its decision on Vascepa by Dec. 28.

Disclaimer: We have no position in Amarin Corporation plc. (NASDAQ: AMRN) and have not been compensated for this article.