Investor Alert

Oct. 22, 2020, 4:38 p.m. EDT

Gilead's stock rises as FDA formally approves remdesivir

Shares of Gilead Sciences Inc. (NAS:GILD) jumped 4.1% in after-hours trading on Thursday after it said the Food and Drug Administration (FDA) had approved Veklury, its COVID-19 treatment, for patients who have been hospitalized with COVID-19 infections. The antiviral drug, until now called remdesivir, in early May had received an emergency use authorization (EUA), which is a less rigorous type of regulatory authorization used during public-health emergencies. Veklury is the first COVID-19 therapy to receive a full FDA approval during the pandemic and has been considered the standard of care when it comes to treating hospitalized patients since it received emergency authorization. The EUA and the approval are based on a series of clinical studies that found Veklury can reduce recovery time when compared to placebo. It can also reduce disease progression among severely ill patients who require oxygen. Gilead announced in August that it plans to seek full approval for the drug. As part of Thursday's announcement, Gilead said the FDA had also authorized the drug for pediatric COVID-19 patients who are 11 years old or younger and who have been hospitalized. Gilead's stock is down 6.6% for the year, while the S&P 500 (S&P:SPX) is up 6.3%.

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