Gilead advancing U.S. application for Kite cell therapy for mantle cell lymphoma
May 3, 2019 9:06 AM ET|About: Gilead Sciences, Inc. (GILD)
|By: Douglas W. House, SA News Editor
In yesterday's Q1 earnings call, Gilead Sciences (NASDAQ:GILD) Chief Scientific Officer and R&D Head John Hutchison stated that the company plans to announce topline results from its pivotal Phase 2 clinical trial, ZUMA-2, evaluating CAR-T candidate KTE-X19 in patients with relapsed/refractory mantle cell lymphoma at ASCO in early June. Assuming a positive outcome, it expects to file a U.S. marketing application by year-end.
Also at ASCO, preliminary data on earlier steroid use with Yescarta (axicabtagene ciloleucel) in relapsed/refractory large B-cell lymphoma will be presented.
Marketing application in Europe for JAK1 inhibitor filgotinib, in-licensed from Galapagos NV (NASDAQ:GLPG), for rheumatoid arthritis will be filed in H2.
Anticipate U.S. approval of supplemental marketing application for an HIV pre-exposure prophylaxis (PrEP) claim for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) in Q4.
Data readout from the Phase 2 ATLAS study evaluating selonsertib, firsocostat, cilofexor and combinations in NASH patients with bridging fibrosis or compensated cirrhosis expected in Q4.