Up 24% pre-market, Amarin stock (AMRN) is looking like it’s hit the right mark, as the FDA considers a study request that could mean a big boom for the pharmaceutical.
The drug study would lead to wider uses for its fish-oil pill, sending shares of biopharmaceutical up 24% as of this writing.
Previously, Amarin asked the FDA to reinstate “a special protocol assessment, which is an agreement between the company and the agency over the design of research.” (via Barchart)
The drug Vascepa is a prescription-strength form of an omega-3 fatty acid. It is Amarin’s only product and it was approved last year for a relatively narrow use in patients with unusually high triglyceride levels.
The company said Friday that the Food and Drug Administration is delaying its decision, which had been expected by Friday, so that it could resolve a question about study design.
The special protocol assessment is expected to be issued by January 15. By that time, AMRN stock is likely to see even larger gains as it focuses on moving toward a big profit.
The news is welcome for AMRN as the company recovers from a terrible year.
Two months ago, FDA advisers voted against recommending broader use, and AMRN stock fell 74% in October. Several insiders noted that company should not have been focusing on fighting the FDA for approval, and instead trying to steer Vascepa sales and obtaining profitability.
The board ruled that while Vascepa significantly lowers fat levels, it was unclear if that meant fewer heart attacks.
Just this week, it was announced that Amarin’s current, CEO, Joe Zakrzewski, would be replaced by John Thero.
Amarin is a biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease.
AMRN is currently down 80% year to date.