Plus   Neg

Amarin Stock Down On Possible AdCom Meeting By FDA Related To Vascepa

In a SEC filing, Amarin Corporation plc (AMRN) stated that it is possible that the FDA will choose to conduct an AdCom meeting with respect to the company's sNDA seeking an expanded indication for Vascepa. Amarin said any delay in obtaining the expanded marketing approval could materially harm the company's business.

However, Amarin noted that the FDA has not yet informed Amarin whether it plans to hold an AdCom meeting.

Shares of Amarin were down more than 9% on the announcement.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration has granted accelerated approval to Tazverik for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Epithelioid sarcoma is a rare sub-type of soft... STIHL recalls about 16,400 STIHL RE 90 pressure washers due to injury hazard. According to the company, the recalled pressure washer nozzle can disconnect from the spray wand when under pressure during use, posing an injury hazard. STIHL said it received seven reports of the nozzle detaching from... CVS Health Corp. launched 13 new HealthHUB locations in CVS Pharmacy stores across Philadelphia and South New Jersey. The healthcare company said it developed the HealthHUB store format to help people manage chronic conditions more conveniently and affordably. The store also features health and wellness products, clinical services and expertise.
Follow RTT