Puma Biotechnology, Inc. (PBYI)

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Article on Seeking Alpha.


ByPoonam A. Arora:

Investment Conclusion. This week, Puma Biotechnology (NYSE:PBYI) reported data from its ExteNET study on Neratinib in the adjuvant setting as 2nd year treatment following a full year of Herceptin therapy for HER2+ breast cancer. The data indicated 33% and 37% improvement over placebo for the overall and subgroup populations. However, the read out was missing DFS figures required to reach any conclusions on the strength of the results. In addition, in the HERA study that evaluated Herceptin as 2nd year treatment following a 1st full year of the drug, the DFS at 3 years follow up approached 89%. Therefore, Neratinib would have to handily beat that statistic for payors to reimburse the drug after a full year of Herceptin, particularly because the HERA study showed no benefit of 2nd year treatment with Herceptin following 1 year with the drug.