Puma Biotechnology Soars After Positive Briefing Documents By FDA For Neratinib
On Monday, Puma Biotechnology (PBYI) soared as much as 89%, before dropping off, after news hit that the FDA released the briefing documents for the Adcom meeting that is scheduled for this Wednesday May 24. The scheduled meeting will discuss whether or not neratinib, Puma's drug, should be recommended for approval.
The Adcom meeting will have a panel of independent experts that will give their professional opinion of the drug. They will then vote to decide if neratinib should be recommended for approval. The path to approval will be for treating patients with HER2-positive early stage breast cancer. The panel recommendation will be just that. It will only recommend whether or not the drug should be approved, but it won't the final decision. The final decision will come by the FDA when it reviews the drug in July 2017.
Phase 3 data to date have been positive. Neratinib showed that it could reduce the risk of death by 26% compared to placebo as an adjuvant therapy. That follows 12 months of treatment with patients that first took Trastuzumab or Herceptin on top of the neratinib drug. This data was analyzed over a 5-year period of the phase 3 ExteNET trial.
Late in the day two analysts put the chances of Adcom approval at no better than 50-50 .
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