Is This the Turning Point Puma Biotech Investors Have Waited For?

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By Chris Lange Updated Jan 13, 2020 at 5:24 AM EST · Published Jul 22, 2016 at 11:10 AM EDT

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Is This the Turning Point Puma Biotech Investors Have Waited For? — © Thinkstock

Puma Biotechnology Inc. (NYSE: PBYI) watched its shares make a handy gain on Friday morning after the firm released updated results from its late-stage breast cancer trial. Although 2016 has been a rough year for biotechs in general, it has been especially bad for Puma with its stock down about 55% year to date, excluding Friday’s move. But a win this big, especially in a late stage trial, begs the question of whether this is a turning point for the company.

The company announced updated results from the Phase 3 clinical trial of Puma’s investigational drug PB272 (neratinib), specifically for the extended adjuvant treatment of HER2-positive early stage breast cancer (ExteNET trial).

The ExteNET trial is a double-blind, placebo-controlled, Phase 3 trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.

The primary endpoint of the trial was invasive disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo.

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As part of the data analysis for the New Drug Application (NDA) filing in the United States and the Marketing Authorisation Application (MAA) submission in Europe, an updated analysis that included an interim five-year invasive DFS analysis was performed. This data analysis was performed in order to examine the durability of treatment effect beyond the two-year data included in the primary analysis.

Alan H. Auerbach, CEO and president of Puma, commented:

We are very pleased with the interim 5-year invasive DFS results from the ExteNET trial with neratinib. We believe these results support the long term clinical benefit of neratinib in the extended adjuvant treatment of patients with early stage HER2-positive breast cancer who have completed prior trastuzumab-based adjuvant therapy. We look forward to obtaining the full 5-year DFS data, which we anticipate will be available in 2017.

Shares of Puma were trading up about 20% at $41.41 Friday morning, with a consensus analyst price target of $66.60 and a 52-week trading range of $19.74 to $107.49.

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