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Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

FDA Concerned About High Dose And Testicular Side Effects

Executive Summary

Complete Response Letter is a major setback for Gilead and its partner Galapagos.

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MANTA Brings Glimmer Of Good News To Galapagos

After a difficult spell for the Belgian biotech, positive interim data from two key studies looking at testicular toxicity concerns over filgotinib suggest a pathway for potential future US approval of the Gilead-partnered JAK inhibitor for IBD.

Ziritaxestat Failure Could Spell End For Gilead/Galapagos Pact

The Galapagos and Gilead partnership has had a tough few months and the failure of ziritaxestat, plus the decision not to develop filgotinib Stateside for rheumatoid arthritis, is calling into question the merits of the whole collaboration for the US biotech.

Galapagos CEO Upbeat Despite Filgotinib Upset In US

Onno van de Stolpe has told Scrip it will take time to win investor confidence back after more disappointing news about the JAK inhibitor but Galapagos has "the pipeline and the cash in the organization to do so."

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