Puma slips on neratinib NDA delay

Puma Biotechnology Inc. (NYSE:PBYI) fell $7.45 (21%) to $27.92 on Tuesday after it said it would submit an NDA for oral neratinib (PB272) in mid-2016, later than expected, to accommodate FDA's request that it rewrite clinical sections of the application. The company had planned to submit the application this quarter. Puma announced the update after market close Monday.

Puma intends to seek approval of the oral inhibitor of HER1, HER2 and HER4 kinases as an adjuvant treatment for breast cancer previously treated with Herceptin trastuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). ...