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Galapagos down on arthritis drug filgotinib stumble

August 19, 2020

Galapagos NV (NASDAQ:GLPG) and licensee Gilead Sciences (NASDAQ:GILD) are down 29% and 7%, respectively, premarket on the heels of a CRL from the FDA regarding GILD’s marketing application for filgotinib for rheumatoid arthritis (RA). The agency’s request for more data will extend the review period well into 2021.

The European Commission should approve filgotinib for RA next month. In late July, the advisory group CHMP adopted a positive opinion backing approval.

The companies inked a 10-year collaboration agreement a year ago that included the Janus kinase inhibitor, an expected blockbuster. GLPG received a $3.95B upfront payment in the deal.

In May, they announced positive results from a Phase 2b/3 study in ulcerative colitis.

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