Amarin hit on FDA action date extension for Vascepa cardio benefit claim

An FDA advisory committee meeting is tentatively set for Thursday, November 14, to review and discuss Amarin’s (NASDAQ:AMRN) supplemental marketing application seeking a cardiovascular (CV) benefit claim for Vascepa (icosapent ethyl).

The FDA’s current action date of September 28 will most certainly be reset.

Management will host a conference call at 7:00 pm ET to discuss the matter.

Shares down 23% after hours.

https://seekingalpha.com/news/3489920-amarin-23-percent-hours-extension-fda-action-date-vascepa-cv-benefit-claim