Gilead to file for US approval of filgotinib this year

3 July 2019

US biotech Gilead Sciences (Nasdaq: GILD) and Belgium-based partner Galapagos (Euronext: GLPG) both saw their shares go up by close of trading yesterday, after Gilead provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib.

Gilead said that, at a recent pre-New Drug Application (NDA) meeting with the Food and Drug Administration, it discussed the Phase III FINCH studies, as well as the ongoing Phase II MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn's disease.

As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019, Gilead noted.

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