Daniel O'Day, AP Images

FDA hands Gilead a stun­ning re­jec­tion for block­buster RA can­di­date fil­go­tinib, deal­ing CEO O’Day a ma­jor set­back

In a sur­prise twist, the FDA has re­ject­ed Gilead’s mar­ket­ing ap­pli­ca­tion for fil­go­tinib, deal­ing a body blow to Daniel O’Day’s hopes for a rapid im­prove­ment in the big biotech’s drug port­fo­lio with a block­buster ad­di­tion.

Late on Tues­day, Gilead $GILD put out word that the agency had turned thumbs-down on their ap­pli­ca­tion for rheuma­toid arthri­tis, say­ing that reg­u­la­tors want­ed to see more da­ta from two on­go­ing safe­ty stud­ies of the drug.

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