Puma Biotechnology Inc. (NASDAQ: PBYI) shares climbed on Tuesday after the company announced that it expects a positive outcome in Europe. Ultimately, the firm believes that neratinib, its treatment of early-stage HER2-positive hormone receptor positive breast cancer, will receive a positive recommendation from the European Medicines Agency (EMA).
It was announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive trend vote recommending the approval of the Marketing Authorisation Application (MAA) for neratinib.
This decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with Puma Bio to discuss the MAA on February 23, 2018. The CHMP communicated its intention to hold a final vote at its next meeting.
Previously, neratinib oral was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. This treatment is currently marketed in the United States.
Excluding Tuesday’s move, Puma had underperformed the broad markets, with its stock down about 41% in the past 52 weeks. In just 2018 alone, the stock was down 48%.
Shares of Puma Bio were last seen up about 18% at $60.10, with a consensus analyst price target of $92.33 and a 52-week range of $47.00 to $136.90.