Puma sinks after CHMP expresses doubts on neratinib

Puma Biotechnology Inc. (NASDAQ:PBYI) slipped $26.20 (29%) to $64.70 on Wednesday after it said EMA's CHMP communicated a "negative trend vote" for its MAA for neratinib as extended adjuvant treatment of early stage HER2-positive breast cancer. Puma said it is now "unlikely" CHMP will recommend the MAA for approval. The formal vote on the MAA is scheduled for February.

Puma said CHMP told the company its benefit-risk assessment of neratinib is negative, since data is based on a single pivotal trial and that the observed two- and five-year invasive disease-free survival (iDFS) benefits "may lack sufficient clinical relevance." CHMP's review is based on the Phase III ExteNET trial and Phase II CONTROL trial of neratinib. ...