Puma wins big FDA OK for ner­a­tinib af­ter run­ning the gamut with in­vestors

Short in­vestors loved to hate Puma Biotech­nol­o­gy, tak­ing the com­pa­ny $PBYI to task for the side ef­fects that ham­pered its lead can­cer drug ner­a­tinib. But the FDA had no trou­ble sanc­tion­ing the prod­uct for breast can­cer, ap­prov­ing it to­day for use in pre­vent­ing re­cur­rence of the dis­ease af­ter the biotech gained a lop­sided vote in its fa­vor among out­side agency ex­perts.

The FDA ap­proved ner­a­tinib — to be sold as Ner­l­ynx — for pre­vent­ing the re­turn of breast can­cer af­ter ther­a­py in­clud­ing trastuzum­ab. And the em­pha­sis in the OK was on adding op­tions for doc­tors and pa­tients.

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