Was Suspension Of Trading In Amarin Corporation plc (ADR) (NASDAQ:AMRN) Required?
Amarin Corporation plc (ADR) (NASDAQ:AMRN) had got lucky since the federal shutdown has not cast its shadow on the meeting scheduled by FDA advisory committee to review its application for its target drug Vescepa. In early October industry watchers were speculating that the meeting might get postponed or cancelled. But Amarin Corporation plc (ADR) (NASDAQ:AMRN) had got confirmation from relevant people with in FDA that the review meeting will go ahead as scheduled. In anticipation of the meeting results, NASDAQ has gone ahead and suspended trading in stock.
Amarin Corporation plc (ADR) (NASDAQ:AMRN) application being considered by FDA advisory committee today relates to expanding the scope of triglyceride Vascepa drug. Readers should note that AMRN had already received FDA certification in 2012. The approval allowed Vascepa usage to treat patients who suffered from high triglyceride levels in their blood. The current application has requested FDA approval to use the same Vascepa drug for treating individuals suffering from high triglyceride and heart disease. The patient profile described in the application also specifies that these patients are being administered a “statin durg” to reduce their cholesterol content.
In the run up to the FDA committee meeting today, Amarin shares had rallied hard scripting a 3.4% increase in its valuation in comparison to its previous day close price. Trade gurus who have studied the workings and dynamics of FDA advisory committee meetings have been predicting that the drug has high probability of getting approved. Analyst firm Jefferies has gone out on a limb to predict that FDA committee will approve the label expansion by a 7-3 vote in favor of the drug maker.
At close of business on October 15, the share price of the drug stock was $5.17. Over the past one week the stock of this $779 million drug manufacturing company has shed close to 22% of its market value.