Indication switch for neratinib delays Puma NDA

Puma Biotechnology Inc. (NYSE:PBYI) sank $27.33 (12%) to $197.67 on Wednesday on news the company will delay submitting an NDA for neratinib until 1Q16.

The delay is based on the company's decision to seek approval of the oral inhibitor of HER1, HER2 and HER4 kinases as an extended adjuvant treatment of HER2-positive early stage breast cancer. It had previously planned to submit its NDA in 1H15 to treat HER2-positive metastatic breast cancer. ...