Amarin Corporation (AMRN) Stock Gains On Vascepa Excitement

Amarin Corporation AMRN Stock News

In just a couple of days, the FDA will be meeting with its advisory committee to discuss the supplemental New Drug Application filed by AMRN. The application seeks to expand the label of the drug to include the reduction of cardiovascular risk in high risk patients.

While advisory committees don’t make the final approval or rejection decision, their opinions are regarded very highly by the FDA. Should the committee vote for the approval of the drug, there’s a strong chance that approval will take place.

In general, shortly after advisory committee meetings are held, biotechnology companies will publish the results of these meetings. So, either late this week or early next week, we can expect to see these results. Given the strong data from the REDUCE-IT trial, supporting the indication expansion, I’m expecting that a vote for approval will take place.

Following this, the next catalyst will be the potential FDA approval of the label change. With a PDUFA date in late December, we’re not far off from the decision.

Keep in mind, this decision could be massive for AMRN and its investors. With no currently approved treatments to reduce cardiovascular risk in this large patient population, and the AHA recently withdrawing their once-daily baby aspirin recommendation, patients have nowhere to turn. So, an approval could turn Vascepa into a smash hit drug!

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