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An expected blockbuster drug from Gilead is rejected, imperiling the biotech's future growth


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.


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.


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  • Galapagos Suffers Record Drop as FDA Fails to Approve DrugMSN Money
  • Gilead's Rheumatoid Arthritis Drug Application Is A No-Go In Present Form: FDAYahoo Finance
  • Gilead arthritis drug won't be approved by FDA in current form, partner Galapagos saysMarketWatch
  • Gilead Sinks After-Hours As FDA Rejects Rheumatoid Arthritis ApplicationYahoo Finance
  • Analysts question Gilead's commitment to arthritis drug after FDA setbackpharmaphorum
  • FDA rejects Gilead's would-be blockbuster filgotinib over toxicity concernsFierceBiotech
  • Galapagos down 29% on arthritis drug filgotinib stumbleSeeking Alpha
  • Abbvie (ABBV) A Clear Beneficiary of Gilead's CRL - Mizuho SecuritiesStreetInsider.com
  • Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to ...GlobeNewswire


This post first appeared on The 5th News, please read the originial post: here

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An expected blockbuster drug from Gilead is rejected, imperiling the biotech's future growth

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