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AstraZeneca (AZN) Farxiga COVID-19 Study Fails to Meet Goal
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AstraZeneca plc (AZN - Free Report) announced data from the primary analysis of DARE-19 phase III study on its blockbuster diabetes medicine, Farxiga to treat patients hospitalized with COVID-19 who are at risk of developing serious complications. The study failed to show statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.
The study was conducted on patients hospitalized with COVID-19 who have pre-existing health conditions like diabetes or chronic kidney disease and are at risk of developing serious complications such as organ failure. It was conducted by AstraZeneca in partnership with Saint Luke’s Mid America Heart Institute.
Farxiga, a SGLT2 inhibitor, is presently approved to treat type II diabetes (T2D) in several countries and heart failure with reduced ejection fraction in the United States and EU. Meanwhile, regulatory applications are under review in the United States and EU,seeking approval of Farxiga for the treatment of chronic kidney disease (CKD).The FDA’s decision is expected in the second quarter of 2021.
This year so far, AstraZeneca’s shares have declined 1.2% compared with a decrease of 0.1% for the industry.
Several outcomes studies are ongoing for evaluating the cardiovascular, renal and organ protection benefits of Farxiga under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies. Farxiga is being studied in the DELIVER phase III study to evaluate its effect on patients with heart failure (HF) with preserved ejection fraction (HFpEF). The DAPA-MI phase III study is evaluating patients without T2D following an acute myocardial infarction (MI) or heart attack.
Farxiga/Forxiga (Farxiga’s name in outside U.S. market), a key top-line driver of AstraZeneca, generated sales worth $1.96 billion in 2020, representing 30% growth at constant exchange rates. Farxiga enjoys global leadership with a significant market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana and Lilly’s (LLY - Free Report) and Boehringer Ingelheim's, Jardiance. Another successful diabetes medicine, which is not a SGLT2 drug, is Novo Nordisk’s (NVO - Free Report) GLP-1 drug, Victoza.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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AstraZeneca (AZN) Farxiga COVID-19 Study Fails to Meet Goal
AstraZeneca plc (AZN - Free Report) announced data from the primary analysis of DARE-19 phase III study on its blockbuster diabetes medicine, Farxiga to treat patients hospitalized with COVID-19 who are at risk of developing serious complications. The study failed to show statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.
The study was conducted on patients hospitalized with COVID-19 who have pre-existing health conditions like diabetes or chronic kidney disease and are at risk of developing serious complications such as organ failure. It was conducted by AstraZeneca in partnership with Saint Luke’s Mid America Heart Institute.
Farxiga, a SGLT2 inhibitor, is presently approved to treat type II diabetes (T2D) in several countries and heart failure with reduced ejection fraction in the United States and EU. Meanwhile, regulatory applications are under review in the United States and EU,seeking approval of Farxiga for the treatment of chronic kidney disease (CKD).The FDA’s decision is expected in the second quarter of 2021.
This year so far, AstraZeneca’s shares have declined 1.2% compared with a decrease of 0.1% for the industry.
Several outcomes studies are ongoing for evaluating the cardiovascular, renal and organ protection benefits of Farxiga under the DapaCare clinical program, which includes more than 35 completed and ongoing phase IIb/III studies. Farxiga is being studied in the DELIVER phase III study to evaluate its effect on patients with heart failure (HF) with preserved ejection fraction (HFpEF). The DAPA-MI phase III study is evaluating patients without T2D following an acute myocardial infarction (MI) or heart attack.
Farxiga/Forxiga (Farxiga’s name in outside U.S. market), a key top-line driver of AstraZeneca, generated sales worth $1.96 billion in 2020, representing 30% growth at constant exchange rates. Farxiga enjoys global leadership with a significant market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s (JNJ - Free Report) Invokana and Lilly’s (LLY - Free Report) and Boehringer Ingelheim's, Jardiance. Another successful diabetes medicine, which is not a SGLT2 drug, is Novo Nordisk’s (NVO - Free Report) GLP-1 drug, Victoza.
AstraZeneca 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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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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