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AstraZeneca (AZN) Gets EU Nod for Evusheld to Treat COVID

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AstraZeneca (AZN - Free Report) announced that the European Commission (EC) granted marketing authorization to its long-acting cocktail antibody therapy, Evusheld, for the treatment of COVID-19.

Evusheld, which is a combination of tixagevimab and cilgavimab, has been authorized to treat adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

The authorization follows a positive review by the Committee for Medicinal Products for Human Use (CHMP), which recommended the use of the antibody therapy for treating COVID-19 infections last week. The decision by the EC and CHMP was based on data from the phase III TACKLE study, which showed a reduced risk of severe COVID-19 or death on treatment with one intramuscular (IM) dose of Evusheld.

In March, AstraZeneca’s Evusheld was granted marketing authorization in the EU for pre-exposure prophylaxis (prevention) of COVID-19 infection in adults and adolescents.

As a result of the new approval by the EC, Evusheld is presently the only long-acting antibody combination available in the European Union for the preventions and treatment of COVID-19.

In the year so far, shares of AstraZeneca have declined 1.5% against the industry’s 4.1% fall.

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Presently, the Omicron BA.5 subvariant is the dominating COVID-19 variant in Europe. Data from clinical studies have demonstrated that the AstraZeneca antibody therapy retains in vitro neutralization `of Omicron BA.5 subvariant.

Other than Europe, Evusheld is also authorized for use in many other countries. Last December, the antibody therapy was granted Emergency Use Authorization (“EUA”) by the FDA for pre-exposure prophylaxis (prevention) of COVID-19 in individuals aged 12 years and older who weigh at least 40 kg.

Another company that markets its monoclonal antibody is Eli Lilly (LLY - Free Report) . In February, the FDA granted a EUA to Eli Lilly’s bebtelovimab, demonstrating neutralization against the Omicron variant. Eli Lilly’s antibody treatment is currently authorized in the United States for treating mild-to-moderate COVID-19 in patients at a high risk of disease progression.

 

Zacks Rank & Stock to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the overall healthcare sector are Morphic (MORF - Free Report) and Sanofi (SNY - Free Report) . While Morphic sports a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 40.4% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.09 to $4.14. Earnings estimates for 2023 have increased from $4.23 to $4.29 during the same period. Shares of Sanofi have lost 20.3% in the year-to-date period.

Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.


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