By Colin Kellaher

 

Shares of Galapagos N.V. and Gilead Sciences Inc. fell Wednesday after the U.S. Food and Drug Administration turned away their new drug application for filgotinib for moderately to severely active rheumatoid arthritis.

The companies said the FDA requested data from studies designed to assess whether filgotinib has an impact on sperm parameters before completing its review of the application.

Top-line results of those studies are expected in the first half of 2021.

Galapagos and Gilead said the agency also expressed concerns about the overall benefit/risk profile of the drug's 200-milligram.

Gilead, a Foster City, Calif., biopharmaceutical company, and Galapagos, a Mechelen, Belgium, biotechnology company, are collaborating on the global development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications.

Shares of Galapagos, which is entitled to a payment of $100 million on approval of filgotinib in the U.S., were recently down 29% to EUR111.75 in European trading.

Shares of Gilead, which is responsible for potential commercialization of the drug in the U.S., fell 4.9% to $65.68 in U.S. premarket trading.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

August 19, 2020 08:09 ET (12:09 GMT)

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