Jim Cramer: Gilead Stock Shouldn't Be Reacting Positively to FDA News

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The Food and Drug Administration cleared Gilead's  (GILD) - Get Report antiviral remdesivir to treat coronavirus patients who require hospitalization.

The drug, which Gilead markets as Velkury, "is now the first and only approved Covid-19 treatment in the U.S.," the company said.

"The drug is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply."

The FDA granted the drug emergency-use authorization in May, allowing hospitals and doctors to use it for patients hospitalized with Covid-19, the disease caused by the coronavirus.

The drug was administered to President Donald Trump earlier in October when he was diagnosed with Covid-19.

Analysts surveyed by Bloomberg expect remdesivir to record sales of $2.17 billion in 2020.

"The development pathway for Veklury as a COVID-19 treatment has been extraordinary. The first patient with COVID-19 received Veklury in January of this year through emergency use protocols, at a time when very little was known about the disease. The case report, published in the New England Journal of Medicine that same month, began the rigorous journey of establishing Veklury’s efficacy and safety profile as a COVID-19 treatment in multiple global, randomized, controlled clinical trials – even as scientists were still learning about the course of the disease itself. Though this journey had many unknowns, our path was guided by decades of experience in antiviral research and development and an unwavering focus on the best interests of patients. Supporting this atypical development pathway was the commitment of clinical trial investigators, patients and their families, and regulatory authorities – all working with the shared goal of rapidly advancing the science to help patients in need," wrote Merdad Parsey, Gilead's Chief Medical Officer. 

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