Is Amarin’s Cardio Trial in Trouble?

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Amarin Corp. PLC (NASDAQ: AMRN) shares dropped on Friday after the firm announced that it received notice from the U.S. Food and Drug Administration (FDA). According to the notice, the FDA plans to hold an advisory committee meeting, tentatively scheduled for November 14, 2019.

This meeting is scheduled in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa (icosapent ethyl) labeling based on the Reduce-it cardiovascular outcomes study.

As a results, Amarin does not expect the FDA to take action on the sNDA by the previously announced September 28, 2019, Prescription Drug User Fee Act (PDUFA) goal date. Also, Amarin did not receive notice from the FDA of a PDUFA date extension.

The company expects that the PDUFA date will be extended, assuming a typical three-month extension, to a date in late December 2019. If so, this anticipated revised PDUFA date timing would offset three of the four months that were expected to be gained from FDA’s earlier determination to conduct a priority review of the Reduce-it sNDA.

John Thero, president and CEO of Amarin, commented:

We look forward to the planned advisory committee meeting as an opportunity to highlight the landmark REDUCE-IT data and the important role we expect Vascepa should play in the treatment of cardiovascular disease in appropriate patients. We plan to continue to work collaboratively with the FDA on the pending REDUCE-IT sNDA while we prepare for a robust launch of REDUCE-IT data assuming approval of Vascepa before the end of 2019 for a cardiovascular risk reduction indication based on REDUCE-IT.

Shares of Amarin traded down about 16% to $14.99 on Friday. The 52-week range is $2.65 to $23.91, and the consensus price target is $32.67.


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