FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA re­view of Amarin’s Vas­cepa rais­es a set of hur­dles the biotech will have to clear if the biotech ex­pects to get the long-await­ed FDA ap­proval that could set it on a path to su­per­star sta­tus. But it ap­pears that Amarin has sur­vived an­oth­er po­ten­tial set­back with­out in­tro­duc­ing a ma­jor new threat to its prospects.

The stakes don’t get much high­er, with an­a­lysts say­ing a win this week for Amarin could lead to bil­lions in new sales — pro­vid­ed the agency stamps it with an OK. And in­vestors liked what they say in the FDA re­view this morn­ing, bump­ing the stock $AM­RN 17%.

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