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Gilead (GILD) Down on COVID-19 Drug Remdesivir Update

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Shares of Gilead Sciences, Inc. (GILD - Free Report) are down in pre-market trading after the World Health Organization (WHO) issued a conditional recommendation against the use of its remdesivir in hospitalized COVID-19 patients, regardless of disease severity.

The WHO stated that there is currently no evidence that remdesivir improves survival and other outcomes in these patients.

Data reviewed by the WHO panel included results from the Solidarity study, as well as 3 other randomized controlled studies. Overall, data from more than 7000 patients across the 4 trials were considered. Per the review, there was no significant effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes with remdesivir treatment.

We note that the FDA recently granted full approval to remdesivir under the brand name, Veklury, for the treatment of patients with COVID-19. The European Commission (“EC”) also granted conditional Marketing Authorization to remdesivir for the treatment of COVID-19.

Veklury generated $873 million in sales primarily in the United States during the third quarter of 2020.

Gilead lowered its annual guidance while reporting the third-quarter 2020 results. The guidance was lowered primarily due to the impacts of the COVID-19 pandemic and lower demand for antiviral drug, Veklury.

Gilead’s shares have lost 7.7% in the year so far compared with the industry’s decline of 2.4%.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few pharma/biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.

Eli Lilly and Company (LLY - Free Report) and partner Incyte (INCY - Free Report) recently announced that the FDA issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory-confirmed COVID-19, who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Pfizer (PFE - Free Report) and BioNTech SE will also be submitting a request to the FDA to grant an Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2.

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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