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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