Shares of Puma Biotechnology (NYSE: PBYI) are up more than 277% Wednesday on volume that is already better than 10 times the daily average after the company said its experimental breast cancer treatment, neratinib, proved successful in a Phase III trial.
“The primary endpoint of the trial was disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo.
“The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015,” according to a statement issued by California-based Puma after the close of U.S. markets.
Puma’s rally is providing relief for biotechnology exchange traded funds a week after Federal Reserve Chair Janet Yellen said valuations for some smaller biotech firms appear stretched. [Big Week for Big Biotech ETF]
The pop in Puma has all five biotech ETFs ranking among the top-six non-leveraged ETFs to this point in Wednesday’s session with the SPDR S&P Biotech ETF (NYSEArca: XBI) leading the way with a gain of almost 6% on volume that has already topped the daily average.
XBI is an equal-weight ETF and none of its holdings account for more than 1.96% of the ETF’s weight. Puma entered the day with a 1.37% weight in XBI, according to State Street data. XBI is the only biotech ETF with exposure to Puma.