Puma Biotech­nol­o­gy shares tank af­ter CHMP looks ready to hit a red light on ner­a­tinib

Six months af­ter Puma Biotech­nol­o­gy won an FDA OK for its can­cer ther­a­py ner­a­tinib, the EMA looks like its prepar­ing to throw up a big road­block in­to Eu­rope over con­cerns its reg­u­la­tors have about the drug. And the news im­me­di­ate­ly trig­gered an­oth­er sharp turn for the biotech’s stock $PBYI, which plunged 27% in af­ter-mar­ket trad­ing.

An­a­lysts have been fret­ting over the Eu­ro­pean de­ci­sion for months now, not­ing that a sci­en­tif­ic ad­vi­so­ry group meet­ing called by the EMA sug­gest­ed that Puma faced some broad chal­lenges that ex­tend­ed be­yond the ev­i­dence of se­vere di­ar­rhea linked to the drug.

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