Company Update (NYSEARCA:PBYI): Puma Biotechnology Inc Announces U.S. FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer


Puma Biotechnology Inc (NYSE:PBYI) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin®)-based therapy.

“The FDA acceptance of our NDA is an important regulatory milestone,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission.”

The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor positive disease, the 2-year invasive DFS rate for the neratinib arm was 95.4% and the 2-year invasive DFS rate for the placebo arm was 91.2%.

Results of the study were published online in The Lancet Oncology on February 10, 2016.

The most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who received neratinib in the ExteNET trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. In patients with HER2-positive early stage breast cancer who have previously been treated with adjuvant trastuzumab and received anti-diarrheal prophylaxis with loperamide, interim results of a Phase II study of neratinib monotherapy demonstrated that treatment with prophylactic loperamide reduced the rate of grade 3 or higher diarrhea to between 13.0% and 18.5%. (Original Source)

Shares of Puma Biotechnology are currently trading at $67.36, up $8.41 or 14.27%. PBYI has a 1-year high of $96.88 and a 1-year low of $19.74. The stock’s 50-day moving average is $54.26 and its 200-day moving average is $39.19.

On the ratings front, PPBYI stock has been the subject of a number of recent research reports. In a report released today, Citigroup analyst Yigal Nochomovitz assigned a Buy rating on PBYI, with a price target of $88, which represents a potential upside of 36.6% from where the stock is currently trading. Separately, on August 9, J.P. Morgan’s Cory Kasimov reiterated a Buy rating on the stock and has a price target of $89.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yigal Nochomovitz and Cory Kasimov have a total average return of -5.8% and -11.2% respectively. Nochomovitz has a success rate of 47.2% and is ranked #3736 out of 4166 analysts, while Kasimov has a success rate of 31.6% and is ranked #4029.

Overall, one research analyst has assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $60.00 which is -6.9% under where the stock opened today.

Puma Biotechnology, Inc. is a development stage biopharmaceutical company. It acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. 

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