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Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of cardiovascular-focused biotechnology company Amarin (Nasdaq: AMRN ) dipped as much as 13% earlier in the trading session after more question marks were raised regarding the marketing exclusivity of Vascepa, its FDA-approved triglyceride reducing drug that, when used in combination with proper diet and exercise, can reduce the risk of heart attack and/or stroke.
So what: In an 8-K released this morning, Amarin noted that it's still awaiting word from the FDA regarding the new chemical entity, or NCE, status of Vascepa. At stake for Amarin is whether or not Vascepa will receive marketing exclusivity for a length of five years. As with all drugs, exclusivity is expected, but not necessarily always granted by the FDA, and that's the primary cause for today's drop.
Now what: I wouldn't completely overreact based on today's 8-K filing if I were an Amarin shareholder, as a delay in an NCE ruling isn't completely uncommon -- but admittedly, shareholders are starting to sweat. The key point here is that Amarin remains a prime takeover target in the biotech sector, and, assuming it finds a solid marketing partner (and trust me, there's no shortage of big pharmaceutical companies with declining pipelines that'd love to get their hands on Vascepa's revenue stream), the long-term future for Amarin remains bright.
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