USA-based Puma Biotechnology (NYSE: PBYI) took its share price rise for the week to nearly 100% after the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted 12 to four to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer.
The committee’s view that the risk-benefit profile of neratinib is favorable during its meeting on Wednesday sent Puma’s stock value up to $74.95 by the close, a 30% rise which followed on from major increases earlier in the week as investors anticipated the panel’s view based on FDA documents on neratinib.
These documents included a review of the clinical development program that featured 11 trials in breast cancer and represented approximately 2,000 patient years’ experience.
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