By Josh Beckerman 



  Gilead Sciences Inc. said the Food and Drug Administration issued a complete response letter for its New Drug Application for rheumatoid arthritis drug filgotinib. 


  The FDA requested data from the MANTA and MANTA-RAy studies, which are designed to assess whether filgotinib has an impact on sperm parameters, Gilead said. The company said it is "disappointed." 


  The agency also expressed concerns regarding the overall benefit/risk profile of the 200-milligram dose. 


  The FDA says it will send an applicant a complete response letter if the agency determines it won't approve an application or abbreviated application in its present form. 


  Gilead and Galapagos NV are collaborating on filgotinib in rheumatoid arthritis and other inflammatory indications. Galapagos said it is revising its cash burn guidance, as prior guidance included an expected $100 million approval milestone. 


  Write to Josh Beckerman at josh.beckerman@wsj.com