Filgotinib falls at final hurdle in rheumatoid arthritis
Shares in California’s Gilead Sciences (Nasdaq: GILD) fell 7% in pre-market trading on Wednesday morning, after the firm announced bad news from the US regulator on its rheumatoid arthritis (RA) candidate filgotinib.
Co-developer Galapagos (Euronext: GLPG), a Belgian company, lost a quarter of its share price after news of the Complete Response Letter (CRL) was announced.
The Food and Drug Administration has requested data from the MANTA and MANTA-RAy studies before completing its review of the submission. The agency also expressed concerns regarding the overall benefit/risk profile of the higher dose of filgotinib.
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