Here’s What Just Happened With Puma Biotechnology, Inc. (NASDAQ:PBYI)

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Over the last week or so, we have repeatedly come back to biotechnology play Puma Biotechnology, Inc. (NASDAQ:PBYI) as part of our Daily Market Movers analysis. The company is one of the most closely watched right now in the space, for reasons we will get into shortly, and we have spent the last few days highlighting this scrutiny, as well as looking at what traders and investors can expect from a variety of different scenarios associated with the situation going forward.

Well, we just got news that one of the major outcomes has hit the press, and it has gone Puma’s way. The company is up close to 90% on its price this time last week and ran 30% during yesterday’s session alone. Premarket on Thursday, an extra 5% was added to this run, and it looks as though Puma could be set to strengthen further as the week draws to a close.

Now we have had this major outcome hit press, let’s take a detailed look at what’s going on and try to figure out what’s coming next.

So, for those that missed our previous coverage of this one, the company is trying to get a drug approved in a breast-cancer indication. Specifically, the drug is called PB272, or neratinib, and it’s designed as a therapy for the extended adjuvant treatment of HER2-positive early stage breast cancer. The breast-cancer population is a dramatically underserved one and has been crying out for new and novel treatments to hit the shelves over the last decade or so. Of course, these new and novel treatments need to be effective as well as safe, and one or both of these requirements has proven the insurmountable hurdle for a number of much-lauded development stage assets in recent times.

And it looked as though Puma’s neratinib was set to go the same way as these failed assets. Concerns over both safety and efficacy, combined with a recommendation by the FDA that the company doesn’t submit a new drug application (NDA) based on the data derived from the pivotal trial on which the submission rests, had markets convinced that any application was futile.

Along the way, some analysts disagreed, and this helped to buoy sentiment somewhat. However, when the company’s regulatory affairs executive resigned earlier this month, markets saw that as something of a nail in the coffin for the development program. Fast forward to Tuesday this week, and we got a look at the brief ahead of an advisory panel meeting. The brief looked more positive than expected and this helped to lift sentiment once more, with markets loading up ahead of the actual meeting itself, in tentative anticipation of something positive.

Well, the outcome of this meeting just read out, and again, it’s positive. Far more positive, in fact, than we could’ve expected.

The panel in question, the FDA’s Oncologic Drugs Advisory Committee (ODAC), voted in favor of recommending approval of the drug by a measure of 12-4. Some concerns were expressed surrounding the label of the drug, and its breadth, but expectations have now shifted from an almost certain regulatory decline to what looks like a shoo-in for approval come PDUFA. As many reading will know, the FDA isn’t obliged to follow the recommendation of its panels, and so nothing is guaranteed. With that said, and especially as far as oncology is concerned, the agency generally falls in line with said recommendations.

So what is next? Well, there isn’t a set PDUFA for this one, but we expect the agency to make a decision at some point during July. This gives the company around eight weeks to get its ducks in a line as far as putting together a commercialization strategy is concerned.

There is also some pertinent phase 3 data set to hit press from Roche (OTCQX: RHHBY), related to a trial in the same indication. The trial is investigating Perjeta and Herceptin in patients with HER2-positive early breast cancer. Puma will be hoping that the trial doesn’t outdo its own asset’s efforts, as while it now looks as though neratinib is set for FDA approval, the fewer competitors it has when it hits the shelves, the better.

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