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Puma Biotechnology (PBYI) stocks edged higher during the course of Tuesday’s session after the FDA approved the new drug application for treating breast-cancer, with shares rallying 13.84% to end the session at $67.11 on heavy trading volume.  

The NDA highlighted ExteNET Phase III study results that showed treatment with neratinib, which contained only 33% lower risk of invasive disease recurrence or death than a placebo treatment.

Further, the recently-announced five-year survival data, along with the Phase II loperamide prophylaxis trial were also included by the NDA, according to RBC Capital Markets.    

"We believe that the above mentioned datasets (5-year survival and loperamide prophylaxis) have been noted by both oncologists and investors and have served to improve sentiment around both the drug and the stock," RBC stated.

"Although this incremental positive was mostly expected, this does remove another overhang/bear argument from Puma," the firm added. 

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The drug’s Marketing Authorization Application (MAA) has been approved by the European Medicines Agency (EMA) last month, suggesting the mid-2017 approval decisions in the U.S. and European Union, RBC noted.

Puma Biotechnology shares traded for today reached about 1.6 million shares, topping the average trading volume of 704,200 shares per day.

Current Shares Stance

The chart below illustrates the current state of PUM stock’s movement, in which three candlesticks were pointed that serves as a trend. Meanwhile, market participants were signaled for a Buy position after the third candle, which in fact did slightly rallied and tried to break out on the upside.

In addition, the succeeding stock significantly climbed on a heavy trading volume with a session high of 246.800, touching four support lines and resting on the upside at support 240.106 on September 16.

Hence, stock prices are currently consolidating, and is prone to an upside bias.          

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Previous Rally Before Drug’s Approval

Shares of Puma Biotechnology were broadly higher with a hefty trading volume on June 24 after the company announced an outstanding results from its Phase 3 PB272 trial in adjuvant breast cancer, as shown in the chart below.

Thus, it appears that the results were far more than stronger, which a added an optimism for Puma to file for FDA approval amid the first half of 2015.

In essence, a rising window was seen after the biopharmaceutical company has announced financial earnings for the second quarter ended June 30,2016, which opened higher at 223.050 and settled at 227.750 at resistance 229.768 and support 219.402.

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Conclusion

Given that the FDA has already approved the new drug application for treating breast-cancer, it is expected that it will give a huge boost in the company’s sales as well as generate exposure in the market.

According to our study, PUM stocks have shown its strength in some factors such as their neratinib drug and the results of their earnings report. Thus, we conclude that stocks were in a bullish trend, but still need to wait for two more supporting candle to make a confirmation.

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