Puma Biotech: A Long-Term Hold

Puma Biotechnology (NASDAQ:PBYI) shares soared 20% on May 24.

First of all, an FDA advisory committee had voted to approve the Puma breast cancer drug.  If we look only at it with a short-term trading eye we might say it is too late to buy.  However, when we pull back to the big picture we will see a few very important – and bullish – features on its chart.

Meanwhile, Puma announced the presentation of positive results from the Phase III clinical trial of Puma’s drug neratinib.  This drug is intended for the extended adjuvant treatment of early stage HER2-positive breast cancer.

In addition, the U.S. Food and Drug Administration approved Neratinib in July 2017 for the treatment of adult patients with early stage HER2-positive breast cancer.  And Puma marekts the drug in the United States as NERLYNX™ (neratinib) tablets.

Most noteworthy, the primary endpoint of the trial was invasive disease free survival (iDFS).  Most noteworthy, the results of the trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death.  In addition, the 5-year iDFS rate for the neratinib arm was 90.2%.

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