Health and Healthcare

Is Puma Biotech For Real, Again?

Puma Biotechnology Inc. (NYSE: PBYI) has just defied all odds in biotech. The stock has risen more than 200% in a single day, and its market cap magically jumped from close to $1.7 billion to almost $7 billion. This is not even on a super-premium buyout by a larger biotech or pharmaceutical giant. We cannot help but to ask if Puma Biotechnology is real or if it is a manipulated move via short interest, options and other outside forces.

The stock had traded more than 4.5 million shares in the first hour and 45 minutes of trading, more than 10 times its normal trading volume for a full day. The driving force behind Puma’s exponential stock gain is positive top line results from its Phase 3 PB272 trial in adjuvant breast cancer. The results were more than strong, and now Puma plans to file for FDA approval in the first half of 2015.

Unlike other smaller studies, this involved thousands of patients in a few dozen countries. Results were looked at over the course of a year as well. It turned out that treatment with neratinib resulted in a 33% improvement in disease-free survival, versus the placebo, in the primary endpoint analysis.

Also, the secondary endpoint of the trial was disease-free survival, including ductal carcinoma in situ. The trial results showed that treatment with neratinib resulted in a 37% improvement in disease-free survival, including ductal carcinoma in situ versus placebo.

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Puma’s press release said:

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial.

As of 11:20 a.m. Eastern Time, Puma Biotech shares were up 273% at $220.50. The stock hit a new high of $234.99.

Where this story gets even more interesting is that this stock rose from under $40 in late 2013, eventually up to more than $120 after the start of 2014. Shares ultimately pulled back to under $60 to close at $59.03 before this news broke.

We would point out that the short interest as of June 30 was up at 1.699 million shares, the largest we have seen in well over a year. That has to be contributing to some of those losses, and biotech short sellers are seeing just how bad being short can be when you are wrong about a company.

The open interest in options contracts was elevated prior to this news, but so much that we would have considered this to rise more than 200% in a day.

Rising from $59 to $220 is no normal move, not even in a super-premium buyout.

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