Portola Pharmaceuticals (NASDAQ:PTLA) could win approvals from the Food and Drug Administration for two important new drugs in the coming year. Its drug betrixaban could become the first of a new class of drugs to be green-lighted for reducing the chance of blood clots forming in acute medically ill patients, and its AndexXa could become the first antidote approved to reverse the effects of top-selling anticoagulants that are already billion-dollar blockbusters.
In this clip from The Motley Fool's Industry Focus: Healthcare podcast, analyst Kristine Harjes and contributor Todd Campbell discuss the opportunity ahead for this biotech, and what's next on deck for investors.
A transcript follows the video.
This podcast was recorded on March 6, 2017.
Kristine Harjes: We have arrived at our last company of the day, which is also this year's biggest winner so far, up 72%. This is a name that Todd and I talk about a lot. We both really like this company. That is Portola Pharmaceuticals.
Todd Campbell: Full disclosure, I happen to be long this one.
Harjes: As am I.
Campbell: It's been up 72% so far this year. Took it on the chin last year, and now we're getting it back.
Harjes: Yeah, they were down 56% in 2016, which did not feel good, especially having to come on the show and be like, "Hey, we were really wrong." But maybe we weren't so wrong. Long-term investing, we're doing OK.
Campbell: The whole concept here -- here's the takeaway for this company: They have got two drugs that could both be blockbuster drugs. And last year, they both stumbled in trying to get these drugs to the FDA. One of the drugs, Betrixaban, we talked about, put up very weird mixed results in trials early last year, and that cast a lot of doubt on whether or not the FDA would be willing to look favorably upon it once they filed their application for approval.
The other one is AndexXa. AndexXa is used to reverse a class of drugs called factor Xa anticoagulants that are used to prevent blood clots. There is no antidote on the market right now. However, last August the FDA sent them a rejection letter because they wanted to get some more information from them. So, that was a one-two punch last year. Then, fast-forward to 2017, Kristine, and guess what? Betrixaban has been filed, and the FDA has said they don't think they're going to need to do an ad-com meeting to discuss Betrixaban, which doesn't guarantee an approval, but certainly increases, in my view, the odds of a go-ahead. And AndexXa, supposedly, they're going to get that refiled soon, too. If they make good on their timeline, they think they could have an approval in hand by the end of this year. So, theoretically, one blockbuster already on the market by late this year, and potentially two on the market next year.
Harjes: Which is pretty incredible, and gives us a lot to look forward to, and I'm sure we'll be discussing them on the show again come June 24th, which is the PDUFA date for Betrixaban or whenever we get the next news about AndexXa.