Shares of Puma Biotechnology Inc. (NYSE: PBYI) had a strong gain in Tuesday’s session following some positive news from the U.S. Food and Drug Administration (FDA). The regulatory body announced that it has accepted for review the New Drug Application (NDA) for Puma’s 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.
As we have said before, the FDA has the potential to make or break a company, in this case a single decision is responsible for over a 10% jump in the stock. Also check out other key FDA decisions that are coming in the next two months.
The submission is supported by the results of the ExteNET Phase 3 study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo.
Specifically, the two-year invasive disease free survival rate for the neratinib arm was 93.9%, and the two-year 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 the placebo.
Alan H. Auerbach, CEO and president of Puma, commented:
The FDA acceptance of our NDA is an important regulatory milestone. 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.
Excluding Tuesday’s move, Puma has underperformed the broad markets, with the stock down 25% year to date. Over the past 52 weeks, the stock is actually down 42%.
Shares of Puma were trading up 13% at $66.62 on Tuesday, with a consensus analyst price target of $69.83 and a 52-week trading range of $19.74 to $96.88.