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Thursday, December 19, 2019

Gilead files U.S. application for filgotinib for rheumatoid arthritis

Gilead Sciences (NASDAQ:GILD) has submitted a marketing application to the FDA seeking approval of filgotinib for patients with moderate-to-severe rheumatoid arthritis.
It filed the application with a Priority Review Voucher which, if the agency accepts it, shortens the review clock to six months.
The company is co-developing and co-commercializing the JAK1 inhibitor with Galapagos NV (NASDAQ:GLPG) under a 2015 agreement. The filing triggers a $20M milestone payment to GLPG.
Gilead Sciences (NASDAQ:GILD) has submitted a marketing application to the FDA seeking approval of filgotinib for patients with moderate-to-severe rheumatoid arthritis.
It filed the application with a Priority Review Voucher which, if the agency accepts it, shortens the review clock to six months.
The company is co-developing and co-commercializing the JAK1 inhibitor with Galapagos NV (NASDAQ:GLPG) under a 2015 agreement. The filing triggers a $20M milestone payment to GLPG.

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