January 23, 2018 / 9:33 PM / in 5 months

BRIEF-Puma Biotechnology Says EMA's CHMP Has Communicated A Negative Trend Vote For Its Breast Cancer Treatment, Neratinib

Jan 23 (Reuters) - Puma Biotechnology Inc:

* PUMA BIOTECHNOLOGY ANNOUNCES RESULTS OF CHMP ORAL EXPLANATION FOR NERATINIB FOR EXTENDED ADJUVANT TREATMENT OF HER2-POSITIVE EARLY STAGE BREAST CANCER

* PUMA BIOTECHNOLOGY - CHMP USE OF EMA COMMUNICATED NEGATIVE TREND VOTE AFTER MEETING WITH CO TO DISCUSS MAA FOR NERATINIB​

* PUMA BIOTECHNOLOGY - NEGATIVE TREND VOTE MEANS IT IS UNLIKELY CHMP WILL PROVIDE POSITIVE OPINION RELATED TO MAA AT FORMAL DECISION VOTE IN FEB. 2018

* PUMA BIOTECHNOLOGY - NEGATIVE TREND VOTE ALSO MEANS ADDITIONAL STEPS WOULD NEED TO BE TAKEN TO GAIN MARKETING APPROVAL IN EUROPE

* PUMA BIOTECHNOLOGY - CHMP INDICATED BENEFIT RISK ASSESSMENT NEGATIVE AS STUDY RESULTS BASED ON EVIDENCE FROM SINGLE PIVOTAL TRIAL, AMONG OTHER THINGS

* PUMA BIOTECH -CHMP INDICATED BENEFIT RISK ASSESSMENT ALSO NEGATIVE AS 2- & 5-YEAR IDFS BENEFITS OBSERVED TO-DATE MAY LACK SUFFICIENT CLINICAL RELEVANCE Source text for Eikon: Further company coverage:

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