Will FDA approve Amarin Corporation plc (ADR) (NASDAQ:AMRN)’s Vascepa?
Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced that the United .States Food and Drug Administration has now scheduled an advisory committee meeting. This meeting will be held on 16 October 2013 and will be in connection with the Vascepa ANCHOR indication. There have been certain lapses in appropriations from the Federal Government. Despite this the meeting will be conducted as has been previously suggested.
In Wednesday’s trading, Amarin Corporation plc (ADR) (NASDAQ:AMRN) dropped by 5.83%. The opening price of the shares was $6.82, which climbed to an intraday high of $6.83 and dipped to a close of $6.30. Approximately 10.88 million shares were traded on Wednesday while an average volume of 5.24 million shares were traded over a 30 day period. The 52-week low of Amarin Corporation plc (ADR) (NASDAQ:AMRN) shares is $5.12 and its 52-week high is $12.96. The company has a market capitalization of $1.08 billion.
About the company
Amarin Corporation plc (ADR) (NASDAQ:AMRN) is a late stage bio-pharma company. It has expertise in lipid-science that is focused on treating cardiovascular disease. AMR101, its product candidate is one ultra-pure Omega 3 fatty-acid. The company is developing AMR101 to be used for treating patients suffering from high triglyceride levels, which is also called hypertriglyceridemia.
In 2011 September, Amarin Corporation plc (ADR) (NASDAQ:AMRN) filed a New Drug Application, with the U.S Food and Drug Administration. In 2011 December, it started patient-dosing in its cardiovascular-outcomes study for AMR101. This study was called REDUCE-IT.
A pivotal trial
The MARINE trial is carried out with Omega 3 fatty-acids and is used in the treatment of patients suffering from extremely high triglycerides. This is a multi-center, Phase-III, randomized, placebo-controlled, double-blind, 12 week study. Patients who were enrolled in this trial had been given the option to get treated with AMR101 for up-to 40-weeks after the last-dose in this pivotal trial.