Gilead's Rheumatoid Arthritis Drug Application Is A No-Go In Present Form: FDA
GILD) shares took a jolt in the after-hours session Tuesday as it announced its application for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA) didn’t get the go-ahead from the United States Food and Drug Administration.
GLPG).
The stock zoomed up to touch almost $84 in April as its new drug, remdesivir showed great potential to treat COVID-19 patients. However, the stock has now dipped below $70 levels for the first time since March as the company’s Q2 results weren’t very exciting.
said Gilead Chief Medical Officer Merdad Parsey.” data-reactid=”29″>”We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA. We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program,” said Gilead Chief Medical Officer Merdad Parsey.
submitted the New Drug Application for filgotinib last December.” data-reactid=”30″>Gilead and Galapagos are collaborative partners in the development of filgotinib. The two companies have multiple clinical programs for the drug in inflammatory diseases. Gilead submitted the New Drug Application for filgotinib last December.
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