Why Puma Biotechnology Inc. Shares Skyrocketed

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 Puma Biotechnology (NYSE: PBYI  ) , a clinical-stage biopharmaceutical company developing therapies to treat various forms of cancer, jumped higher by as much as 58% after reporting positive top-line results from its phase 2 I-SPY 2 trial with PB272 (known scientifically as neratinib) as a neoadjuvant treatment for stage 2 or higher breast cancer.

So what: According to Puma's press release from yesterday, in its randomized 300-patient confirmatory trial, neratinib -- when combined with paclitaxel and followed by doxorubicin and cyclophosphamide -- should demonstrate a high rate of success in late-stage trials with the HER2-positive/HR-negative signature. Within this grouping, the neratinib arm delivered a p-value of 0.053, or a 94.7% probability of superiority over the current standard of treatment according to Bayesian predictive models. Furthermore, neratinib-based regimens demonstrated a Bayesian probability of superiority over paclitaxel plus Herceptin of 78.1% if they were to go head to head in a phase 3 trial.

Now what: Simply put, no one really expected Puma's results to be this strong, which is why we're seeing such a monstrous move to the upside. Not to sound like a broken record, but I would still like to see the full data before stating my full opinion on Puma (the company will release its full data at a scientific meeting in the future). I've witnessed far too many cancer drugs demonstrate promise in mid-stage trials only to disappoint in late-stage trials, so my thought at the moment is that sticking to the sidelines until we're well into late-stage trials might be the smartest course of action.

This growth stock might trump Puma
While Puma Biotechnology is certainly rewarding shareholders today, over the long run it may not be able to hold a candle to this incredible tech stock which is growing twice as fast as Google and Facebook, and more than three times as fast as Amazon.com and Apple. Watch our jaw-dropping investor alert video today to find out why The Motley Fool's chief technology officer is putting $117,238 of his own money on the table, and why he's so confident this company will be a huge winner in 2013 and beyond. Just click here to watch!


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  • Report this Comment On December 05, 2013, at 5:04 PM, wolfwork wrote:

    I agree about holding off on this jump right now, and the need to see the data. Not only to see how it did in its own right against the control arm, but to try to guess (in the absence of a head to head trial) how PB272 might compare relative to the combination of Perjeta plus Herceptin and chemotherapy.

    Moreover, this drug has had past experiences with failure, with Pfizer pulling the agent from two Phase III trials before selling the rights to Puma. Investors need to tread cautiously.

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