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Back before remdesivir became a household name, Gilead Sciences’ most-discussed drug was filgotinib, a treatment for inflammatory disease expected to deliver billions of dollars in new revenue at a time when the biotech desperately needs it. All that got put in jeopardy on Tuesday night.

The FDA rejected Gilead’s application to sell filgotinib as a treatment for rheumatoid arthritis and said it wouldn’t reconsider until the company can provide more data on the drug’s effect on patients’ sperm counts. Gilead is running two studies to determine exactly that, but it won’t have results until sometime next year.


Gilead shares are down 6% to $65 in Monday premarket trading, a loss of nearly $6 billion in market value. Shares of Belgian drug maker Galapagos, which is in line to receive royalties on filgotinib sales, are down 29% to $133.

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  • I have followed Robin Karnaukas and her reporting for decades and trust implicitly what she says.
    The only meek excuse O’Day and his people can come up with would be something like we did not initiate this strategy to expand in this therapeutic area nor decided to collaborate with GLPG so blame it on the previous regime of Martin, Milligan, and Bischihifberger! We are fully committed to and have high hopes for oncology for this company’s future! Really? Good luck with that!

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