Hit by an ex­pect­ed EMA re­jec­tion, Puma plans to ap­peal neg­a­tive opin­ion on ner­a­tinib

Ex­act­ly a month af­ter warn­ing Puma Biotech­nol­o­gy $PBYI of a neg­a­tive trend vote re­gard­ing ner­a­tinib, Eu­ro­pean reg­u­la­tors have come down with a for­mal neg­a­tive opin­ion for the can­cer drug.

In a brief note, Puma told in­vestors that the CHMP has rec­om­mend­ed the re­fusal of the mar­ket­ing au­tho­riza­tion ap­pli­ca­tion for ner­a­tinib as a treat­ment of ear­ly-stage HER2-pos­i­tive breast can­cer. Giv­en that the Eu­ro­pean Com­mis­sion usu­al­ly fol­lows EMA rec­om­men­da­tions, a red light is like­ly to fol­low.

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