Puma rises on neratinib survival data, NDA submission

Puma Biotechnology Inc. (NYSE:PBYI) jumped $7 (20%) to $41.52 on Friday after the company disclosed interim five-year disease-free survival (DFS) data from the Phase III ExteNET trial of oral neratinib (PB272) and said it had submitted an NDA to FDA for the breast cancer therapy.

On a conference call after market hours Thursday, President and CEO Alan Auerbach said the new ExteNET data seem to show a durable DFS benefit, countering a perception that the benefit "appeared to be contracting" over time. Puma conducted the analysis, which was neither pre-specified nor requested by FDA, to evaluate the durability of responses to neratinib. ...