Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD ex­ecs haven’t de­cid­ed ex­act­ly what to do with fil­go­tinib in the wake of the slap­down at the FDA on their rheuma­toid arthri­tis ap­pli­ca­tion, but they’re tak­ing a time out for a slate of stud­ies un­til they can gain some clar­i­ty from the agency. And with­out en­cour­ag­ing guid­ance, this drug could clear­ly be axed from the pipeline.

In their Q3 re­port out Wednes­day af­ter­noon, the com­pa­ny says re­searchers have “paused” a Phase III study for pso­ri­at­ic arthri­tis along with a pair of Phase II tri­als for anky­los­ing spondyli­tis and uveitis. Late-stage stud­ies for ul­cer­a­tive col­i­tis and Crohn’s are con­tin­u­ing, but you can see for your­self how big a hole this leaves in the in­flam­ma­to­ry dis­ease pipeline, with ob­vi­ous im­pli­ca­tions if the com­pa­ny aban­dons fil­go al­to­geth­er.

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