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FDA Accepts AstraZeneca (AZN), Sanofi's RSV Antibody BLA
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AstraZeneca (AZN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA accepted their biologics license application (BLA) seeking approval for nirsevimab as a first protective option against respiratory syncytial virus (RSV) disease for all infants. A final decision from the regulatory body is expected in third-quarter 2023.
Nirsevimab is a single-dose long-acting antibody designed to prevent lower respiratory tract infections (LRTI) caused by RSV. If approved by the FDA, it would be the first single-dose RSV preventative option for the broad infant population in the United States.
The AstraZeneca/Sanofi filing seeks approval for nirsevimab to prevent RSV lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The BLA is being supported by data from the comprehensive nirsevimab clinical development program, including the phase III MELODY study, the phase II/III MEDLEY study and multiple phase IIb studies. Data from these studies showed that nirsevimab achieved consistent protection of approximately 80% against medically attended RSV disease with a single dose.
Nirsevimab received its marketing authorization in the European Union (EU) in November 2022, where it is being marketed under the trade name Beyfortus. Currently, Beyfortus is approved in the EU for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season
In the past year, shares of AstraZeneca have gained 23.1%, while Sanofi’s shares have lost 3.8%. During the same period, the industry has risen 15.4%.
Image Source: Zacks Investment Research
If approved with the designated time period, AstraZeneca/Sanofi expects to launch nirsevimab in the country during the 2023/2024 RSV season. Per the companies, the FDA indicated that it will expedite the BLA review timeline.
Currently, there are no FDA-approved treatments against RSV infections anywhere in the United States. The LRTI-RSV disease causes a high rate of morbidity and mortality in young kids.
AstraZeneca and Sanofi entered into an agreement in 2017 to jointly develop and commercialize nirsevimab. Per the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi leads commercialization activities and records revenue. The two companies share costs and profits.
While AstraZeneca carries a Zacks Rank #3 (Hold), Sanofi holds a Zacks Rank #2 (Buy). A couple of better-ranked stocks in the overall healthcare sector is Allogene (ALLO - Free Report) and Syndax Pharmaceuticals (SNDX - Free Report) . While Syndax Pharmaceuticals sports a Zacks Rank #1 (Strong Buy) at present, Allogene carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Allogene’s 2022 loss per share have narrowed from $2.39 to $2.38. In the same period, the loss per share estimate for 2023 has narrowed from $2.84 to $2.82. Shares of Allogene have declined 57.3% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.
In the past 60 days, estimates for Syndax Pharmaceuticals’ 2022 loss per share have narrowed from $2.59 to $2.48. In the same period, loss estimates for 2023 have narrowed from $2.77 to $2.57. Shares of Syndax Pharmaceuticals have risen 23.7% in the past year.
Earnings of Syndax Pharmaceuticals beat estimates in three of the last four quarters, while meeting the mark on one occasion, witnessing an earnings surprise of 95.39%, on average. In the last reported quarter, Syndax Pharmaceuticals’ earnings beat estimates by 10.77%.
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FDA Accepts AstraZeneca (AZN), Sanofi's RSV Antibody BLA
AstraZeneca (AZN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA accepted their biologics license application (BLA) seeking approval for nirsevimab as a first protective option against respiratory syncytial virus (RSV) disease for all infants. A final decision from the regulatory body is expected in third-quarter 2023.
Nirsevimab is a single-dose long-acting antibody designed to prevent lower respiratory tract infections (LRTI) caused by RSV. If approved by the FDA, it would be the first single-dose RSV preventative option for the broad infant population in the United States.
The AstraZeneca/Sanofi filing seeks approval for nirsevimab to prevent RSV lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The BLA is being supported by data from the comprehensive nirsevimab clinical development program, including the phase III MELODY study, the phase II/III MEDLEY study and multiple phase IIb studies. Data from these studies showed that nirsevimab achieved consistent protection of approximately 80% against medically attended RSV disease with a single dose.
Nirsevimab received its marketing authorization in the European Union (EU) in November 2022, where it is being marketed under the trade name Beyfortus. Currently, Beyfortus is approved in the EU for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season
In the past year, shares of AstraZeneca have gained 23.1%, while Sanofi’s shares have lost 3.8%. During the same period, the industry has risen 15.4%.
Image Source: Zacks Investment Research
If approved with the designated time period, AstraZeneca/Sanofi expects to launch nirsevimab in the country during the 2023/2024 RSV season. Per the companies, the FDA indicated that it will expedite the BLA review timeline.
Currently, there are no FDA-approved treatments against RSV infections anywhere in the United States. The LRTI-RSV disease causes a high rate of morbidity and mortality in young kids.
AstraZeneca and Sanofi entered into an agreement in 2017 to jointly develop and commercialize nirsevimab. Per the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi leads commercialization activities and records revenue. The two companies share costs and profits.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Sanofi Price
Sanofi price | Sanofi Quote
Zacks Rank & Stock to Consider
While AstraZeneca carries a Zacks Rank #3 (Hold), Sanofi holds a Zacks Rank #2 (Buy). A couple of better-ranked stocks in the overall healthcare sector is Allogene (ALLO - Free Report) and Syndax Pharmaceuticals (SNDX - Free Report) . While Syndax Pharmaceuticals sports a Zacks Rank #1 (Strong Buy) at present, Allogene carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Allogene’s 2022 loss per share have narrowed from $2.39 to $2.38. In the same period, the loss per share estimate for 2023 has narrowed from $2.84 to $2.82. Shares of Allogene have declined 57.3% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.
In the past 60 days, estimates for Syndax Pharmaceuticals’ 2022 loss per share have narrowed from $2.59 to $2.48. In the same period, loss estimates for 2023 have narrowed from $2.77 to $2.57. Shares of Syndax Pharmaceuticals have risen 23.7% in the past year.
Earnings of Syndax Pharmaceuticals beat estimates in three of the last four quarters, while meeting the mark on one occasion, witnessing an earnings surprise of 95.39%, on average. In the last reported quarter, Syndax Pharmaceuticals’ earnings beat estimates by 10.77%.