Puma plunges as filing date for neratinib delayed

29 March 2016

USA-based Puma Biotechnology (Nasdaq: PBYI) says that, following recent meetings with the Food and Drug Administration, the company now plans to submit its New Drug Application (NDA) for the approval of neratinib for the treatment of extended adjuvant breast cancer in mid-2016.

This is later than the first-quarter filing that was originally scheduled, and the news sent the company’s shares plunging 27.5%$25.64 in mid-morning trading today.

Puma has recently conducted a series of meetings and communications with the FDA. The purpose of these was to provide the FDA with the data from neratinib’s non-clinical and clinical development programs that will form the basis of the company’s NDA for neratinib for the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen.

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