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 BioCryst Pharmaceuticals (NASDAQ:BCRX), a biopharmaceutical company that develops drugs to block enzymes involved in the development of various diseases, jumped as much as 15% after announcing that its new drug application for peramivir had been accepted by the Food and Drug Administration.
So what: According to its press release before the opening bell this morning, BioCryst noted that the FDA accepted its NDA that was filed in December for peramivir, an intravenous investigational anti-viral agent that "inhibits interactions of influenza neuraminidase," which is an enzyme that's critical to the spread of the influenza virus within a host. BioCryst's NDA was assigned a standard 10-month review with a PDUFA action date of Dec. 23, 2014. The drug is already approved in Japan and South Korea.
Now what: Obviously, this has big potential to affect BioCryst's top line in a big way and potentially reduce its current losses. Then again, approval of peramivir in Japan was supposed to generate significant revenue that, as of now, I'd call very disappointing. On paper, peramivir appears to be a smart choice for a select group of oral and inhaled-intolerant patents, but BioCryst is going to need to execute everything flawlessly if it hopes to maintain its lofty valuation. I personally see limited upside in shares here and would suggest investors exercise caution moving forward until well after a possible approval.