Amarin (AMRN) Could Get FDA Catalysts By Year-End, Says Leerink Swann

August 9, 2013 10:59 AM EDT
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Price: $2.95 +2.43%

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Leerink Swann maintained an Outperform rating on Amarin Corporation (NASDAQ: AMRN) and adjusted its price target to $18.00 (from $20.00). Analyst Joseph P. Schwartz noted Vascepa's improved reimbursement positioning. More importantly, he is looking forward to FDA catalysts by year-end.

"AMRN is in advanced planning and preparation stages for the anticipated launch of Vascepa for the ANCHOR indication, which will have an FDA advisory panel that we expect to be positive (including briefing documents released a couple days prior) on October 16, 2013," said Schwartz. "The PDUFA date is December 20, 2013, whereupon we expect approval of Vascepa for mixed-dyslipidemia, and positive ANCHOR clinical data to be added to the label.

"Management believes that FDA is holding panel since Vascepa was the second drug in its class to be approved in the first indication of very high triglycerides but not the next indication of mixed dyslipidemia and the size and scope is also much larger as 1 in 5 Americans have this disorder. AMRN has been preparing with advisors to answer a broad range of questions that could be asked. We continue to expect the favorable clinical profile to support approval and an SPA should de risk the approval. We believe it is not logical to extrapolate from failed studies of different drugs such as fibrates or niacin in this indication, or failed studies of Omacor/Lovaza at one-quarter the dose in different diseases," he added.

For an analyst ratings summary and ratings history on Amarin Corporation (NASDAQ: AMRN) click here. For more ratings news on Amarin Corporation click here.

Shares of Amarin Corporation closed at $5.31 yesterday.

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