Daniel O'Day, AP Images

FDA hands Gilead a nice CAR-T boost as crit­ics pounce on un­der­whelm­ing Q4 call and Twit­ter buzzes with M&A chat­ter

Gilead, which has had to face down some with­er­ing crit­i­cism in re­cent days, got a nice win at the FDA to boast about. The agency hand­ed out their pri­or­i­ty re­view track for the big biotech’s sec­ond CAR-T, KTE-X19.

The drug — part of their CAR-T camp at Kite — is be­ing squired through a quick 6-month re­view for re­lapsed or drug-re­sis­tant man­tle cell lym­phoma, like­ly in­di­cat­ing that Richard Paz­dur’s on­col­o­gy team is ready to hand out a swift stamp of ap­proval.

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