Puma: CHMP reversing course to favor neratinib's approval

Puma Biotechnology Inc. (NASDAQ:PBYI) said EMA's CHMP is likely to recommend approval of oral neratinib as extended adjuvant treatment of early stage, hormone receptor-positive, HER2-positive breast cancer. The company's shares were up $12.45 (24%) to $63.55 on Tuesday.

Puma said the committee has adopted a "positive trend vote" on the application, which typically augurs a formal recommendation. A positive recommendation would reverse a February decision by the committee to recommend refusal of neratinib's MAA, which followed a "negative trend vote" in January. Puma subsequently requested a re-examination (see "Puma Sinks After CHMP Expresses Doubts on Neratinib"). ...