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AstraZeneca (AZN) Evusheld Gets Japan Nod as COVID Treatment

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AstraZeneca (AZN - Free Report) announced that its antibody cocktail medicine, Evusheld has gained its first global approval as a COVID-19 treatment. Evusheld, which is a combination of tixagevimab and cilgavimab, has gained approval in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by the SARS-CoV-2 infection.

Until now, Evusheld was authorized for use in pre-exposure prophylaxis of COVID-19 in certain high-risk populations in Europe, the United States and some other countries.

In prevention, Evusheld is authorized in Japan for use in adults and adolescents (12 years of age and older weighing at least 40kg) for whom COVID vaccination is not recommended and who may have an inadequate response to a COVID-19 vaccine due to immunodeficiencies. In treatment, Evusheld is approved for adults and adolescents who are at high risk of severe infection and who do not require supplemental oxygen.

AstraZeneca has an agreement with Japan’s government to purchase 300,000 units of Evusheld. For the treatment indication, AstraZeneca expects to file regulatory applications in several countries soon.

This year so far, AstraZeneca’s shares have risen 8.8% against a decrease of 2.6% for the industry in the said time frame.

 

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The approval in Japan was based on data from the PROVENT prevention and TACKLE outpatient treatment phase III studies.

Data from the PROVENT prevention study showed that one 300mg IM dose of Evusheld reduced the risk of developing symptomatic COVID-19 compared to placebo by 77% at primary analysis and 83% at a follow-up analysis. Data from the TACKLE outpatient treatment study showed that a 600 mg dose of Evusheld, given by intramuscular injection, reduced the risk of developing severe COVID-19 or death (from any cause) by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.

Zacks Rank & Stocks to Consider

AstraZeneca has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Morphic (MORF - Free Report) , Sesen Bio and Agenus (AGEN - Free Report) , all carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 42.1% 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.

Sesen Bio’s loss estimates for 2023 have narrowed from 27 cents per share to 1 cent per share over the past 30 days. Shares of Sesen Bio have declined 16.6% this year so far.

Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.

Agenus’ loss per share estimates for 2022 have narrowed from 89 cents to 70 cents in the past 30 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 16.7% in the year-to-date period.

Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.


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