E Portola Pharmaceuticals Inc. Is A Stock To Watch With Caution Ahead Of PDUFA

Next month, Portola Pharmaceuticals Inc (NASDAQ:PTLA) will hear back from the FDA as to whether its Andexanet alfa candidate will pick up approval or not. In March, Portola took a real hit, as data from another of its lead candidates (this time in the opposite indication – we'll address this in a little more detail shortly) fell short of expectations. On that data's release, Portola lost nearly 35% of its market capitalization, and while it has since recovered about half of these losses, it remains well down on both its 2016 open (-48%) and its 2015 highs (-57%). If the upcoming FDA decision swings in its favor, sentiment could quickly reverse and we could see some sharp upside on approval.

With this in mind, here's a look at the drug in question, and what an approval might mean for Portola going forward into the latter half of the year and beyond.

So, as mentioned, the drug is called Andexanet alfa. Explaining exactly what it targets is pretty complicated, without going into how it works, but stick with us and we'll try and simplify both. There are a wide range of conditions that arise from blood that is too thin. Thrombosis is one, high blood pressure is another. They can cause a range of symptoms and – in turn – complications, but the worst case scenario is a blood clot. Blood clots restrict flow, and have obvious implications. In order to mitigate the risk of blood clots happening in patients with – for want of a better phrase – thick blood, physicians administer from a family of drugs called anticoagulants. A good example is warfarin. There are a few different types of anticoagulant, but one of the primary (new generation) types is what are called direct Xa inhibitors. Factor Xa is an activated form of a coagulation factor called thrombokinase, and without going into too much detail, inhibits  Xa from undertaking its standard actions (which is to cause clotting and coagulate blood), and in doing so, serves as a blood thinner.

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