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Gilead's (GILD) Veklury Gets EC Nod for Use in Early COVID-19

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Gilead Sciences, Inc. (GILD - Free Report) recently announced that the European Commission (“EC”) has expanded the label for antiviral Veklury (remdesivir) for use at early stages of COVID-19 to help prevent disease progression in high-risk patients in the EU.

Veklury can now be used for adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.  Veklury was previously granted Conditional Marketing Authorization to treat COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of the treatment).

This expanded indication follows the positive recommendation of the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, for Veklury amid rising COVID-19 cases and the emergence of new variants like Omicron.

The EC’s decision is supported by results from a late-stage double-blind, placebo-controlled study to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.  Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by day 28 compared with placebo.

Please note that Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization in the United States. The use of Veklury for the treatment of non-hospitalized patients with three days of dosing in the United States is investigational.

Shares of Gilead have rallied 24.4% so far this year against the industry’s decrease of 19.8%.

Zacks Investment ResearchImage Source: Zacks Investment Research

Veklury sales have boosted Gilead’s sales in the year, and expanded indications should further drive sales.

The rapidly spreading Omicron variant is questioning both the efficacy of vaccines and other treatments.

Pharma/biotech companies worldwide are evaluating every arsenal in their armory to combat the ongoing pandemic, but the rising variants have become a cause of concern. Consequently, regulatory bodies worldwide are scurrying to authorize every possible treatment that can control and treat the infected.

Vir Biotechnology, Inc. (VIR - Free Report) and partner GlaxoSmithKline (GSK - Free Report) recently announced that the EC has granted marketing authorization to neutralizing monoclonal antibody sotrovimab for the early treatment of COVID-19 under the brand name Xevudy.

Xevudy is now approved in the European Union for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

Glaxo and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. Vir and Glaxo had earlier reported preclinical data, which showed that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest.

Zacks Rank & Stock to Consider

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics, Inc. (SRPT - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 60 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.