Gilead Gives Up On Galapagos's Filgotinib In RA
Belgian Biotech's Stock Battered
A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.
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New chief financial officer Thad Huston said that Galapagos was evaluating “various strategic options for Jyseleca,” the company’s only revenue source, given that the landscape for the JAK class in Europe “has changed significantly over the past six months.”
The company reported the Phase III DIVERSITY trial of Jyseleca did not meet its primary endpoint in Crohn’s disease, closing another path to the US market.
The company has eight lung cancer trials running and plans for nine by the end of the year, including five with Trodelvy alone. Gilead is also looking ahead to an FDA verdict on lenacapavir.