2 years Gilead Shares Gain as Drugmaker Readies COVID-19 Treatment Donation After ‘Lighting Fast’ FDA Approval     

Gilead will donate 1.5 million vials of remdesivir to U.S. hospitals this week, allowing for as many as 140,000 coronavirus treatments following last week’s emergency authorization approval by the FDA.

Gilead Sciences  (GILD) – Get Report bumped higher in pre-market trading Monday after the drugmaker’s CEO said doses of its developing coronavirus treatment could be available this week following emergency approval from the U.S. Food and Drug Administration.

Gilead CEO Daniel O’Day told CBS’s Face the Nation Sunday that his company is working with health officials to determine “which cities are most vulnerable and where the patients are that need this medicine” as it rolls out 1.5 million donations of its remdesivir coronavirus treatment. The donation, which comprises all of the group’s current stock. would allow for between 100,00 and 200,000 individual tests, O’Day said, depending on the length of treatment. 

Last Friday, the FDA approved the emergency use of remdesivir on patients suffering severe COVID-19 symptoms in a decision Commissioner Stephen Hahn said was taken at “lighting speed”.

“We are now firmly focused on getting this medicine to the most urgent patients around the country here in the United States,” O’Day said on “Face the Nation.” “We intend to get that to patients in the early part of this next week, beginning to work with the government, which will determine which cities are most vulnerable and where the patients are that need this medicine.”

Gilead shares were marked 2.5% higher in pre-market trading Monday, against an expected 0.75% decline for the Nasdaq Composite index, and indicating an opening bell price of $81.98 each.

Last week, Gilead sent U.S. markets surging after it said that key trials in the United States suggested ‘positive results for its nascent coronavirus treatment. 

Gilead said “positive data emerging from the National Institute of Allergy and Infectious Diseases'” study of remdesivir indicates the treatment has “met its primary endpoint” and also noted that its own study showed that nearly two thirds of the nearly 400 severe-stage coronavirus patients using remdisivir were discharged from hospital after using the treatment early, a better rate than those given the drug at a later stage. 

The studies contradicted reports leaked on the World Health Organization website last month that suggested remdesivir had little success in a China-based study that was halted after authorities said there weren’t enough patients enrolled.

“We regret that the WHO prematurely posted information regarding the study, which has since been removed,” Gilead said in a statement. “The investigators in this study did not provide permission for publication of results.”

“Furthermore, we believe the post included inappropriate characterizations of the study,’ Gilead said at the time. “Importantly, because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions.”

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