CHMP re­vers­es course on ner­a­tinib, hand­ing Puma an un­ex­pect­ed win on Eu­ro­pean mar­ket­ing vote — shares soar

Puma Biotech­nol­o­gy $PBYI CEO Alan Auer­bach just beat some heavy odds weigh­ing against ner­a­tinib.

Af­ter ap­peal­ing a neg­a­tive opin­ion adopt­ed by the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use, the EMA group has re­versed course and is now rec­om­mend­ing an ap­proval. The com­mit­tee mem­bers had ini­tial­ly sided against a green light, cit­ing con­cerns over the se­ri­ous di­ar­rhea linked with the drug as well as the rel­e­vance of the late-stage da­ta they saw in ex­tend­ed ad­ju­vant ear­ly-stage HER2-pos­i­tive breast can­cer.

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