Shares of Gilead Sciences fell 3per cent after the U.S. Food and Drug Administration declined to approve its experimental rheumatoid arthritis ...
Shares of Gilead Sciences fell 3per cent after the U.S. Food and Drug Administration declined to approve its experimental rheumatoid arthritis treatment, a major setback for one of the drugmaker's important products.
Gilead's antiviral medicine remdesivir has put the company at the forefront of the fight against the COVID-19 pandemic, sending its shares soaring, but analysts said the FDA move could cost it millions in delayed sales while it fights to get the drug approved.Last year, Gilead invested US$5.1 billion in a major expansion of its partnership with Belgo-Dutch biotech Galapagos NV , banking on the potential of filgotinib and other drugs in development.
J.P. Morgan analyst Cory Kasimov, who had forecast US$2 billion in annual peak sales for the drug, said the request for data could delay any potential approval by at least a year, while "the potential lack of dosing flexibility" could hurt the drug's competitive profile.
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