Amarin's ($AMRN) plodding effort to get Vascepa approved for a wider indication just got longer as the FDA delayed its final decision on the fish oil pill, but the company's backers are staying optimistic, and shares jumped as much as 20% on Friday morning.
The company is looking to expand the label of its cholesterol-fighting omega-3 drug, and the FDA was due to make a final ruling Friday. The delay, however, makes procedural sense: In October, the agency backed out of its support for the design of Amarin's ANCHOR study, eliciting an appeal from the company. Regulators would be loath to make a final decision on a drug without first weighing in on its supporting data, and the agency told Amarin it will rule on the study design appeal by Jan. 14, the company said.
Just when the FDA will make a decision on Amarin's supplemental drug application remains unknown, and the company notes in its announcement that "there can be no assurance that Amarin will be successful in this effort."
Investors were much cheerier, however, sending Amarin's now-pilloried shares up in premarket trading. Still, the company has plummeted by about 75% since October, when an FDA panel cast serious doubt on its odds of winning approval to sell Vascepa to patients with less-severe high triglycerides.
The ensuing consternation led Amarin to slash its payroll and may have spelled the demise of CEO Joe Zakrzewski, who will walk out the door Jan. 1 in what the company is calling a "retirement."
- read the announcement