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Sanofi (SNY) Gets CHMP Nod for Enjaymo in Hemolytic Anemia
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Sanofi (SNY - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving Enjaymo (sutimlimab), its C1 protein inhibitor, to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD).
A final decision by the European Commission (EC) is expected by year-end.
The CHMP decision is based on positive data from two late-stage clinical studies – CADZENA and CARDINAL – which evaluated Enjaymo in adult patients with CAD. While the CADZENA study evaluated the drug in patients without a recent history of blood transfusion in the past six months, the CARDINAL study evaluated the drug in patients with a history of blood cell transfusion.
In the year so far, shares of Sanofi have declined 18.5% compared with the industry’s 3.3% fall.
Image Source: Zacks Investment Research
CAD is a rare type of hemolytic anemia (i.e., breakdown of red blood cells) wherein the body’s immune system mistakenly destroys healthy red blood cells. A monoclonal antibody, Enjaymo is designed to target and inhibit C1 protein, which is a part of the innate immune system. This, in turn, prevents the destruction of healthy red blood cells.
Enjaymo was approved by the FDA in early February as the first and currently the only approved treatment for red blood cell transfusion due to hemolysis in adults with CAD.
In a separate press release, Sanofi announced that the CHMP has also recommended granting marketing authorization to nirsevimab, a long-acting antibody. The antibody has been developed for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The antibody has been developed in collaboration with AstraZeneca (AZN - Free Report) . If approved, the product is expected to be marketed under the trade name Beyfortus.
The CHMP’s endorsement is based on data from multiple studies, which were part of the Beyfortus clinical development program. These studies achieved their primary endpoint and showed a consistent drug safety profile in study participants.
Sanofi and AstraZeneca entered into an agreement in 2017 to develop and commercialize Beyfortus. Per the terms of the agreement, AstraZeneca will be responsible for manufacturing and development activities, while SNY will be responsible for commercialization of the same once it receives approval.
Sanofi currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are Kamada and Morphic (MORF - Free Report) , which sports 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 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 27.7% in the year-to-date period.
The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 39.8% 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%.
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Sanofi (SNY) Gets CHMP Nod for Enjaymo in Hemolytic Anemia
Sanofi (SNY - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving Enjaymo (sutimlimab), its C1 protein inhibitor, to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD).
A final decision by the European Commission (EC) is expected by year-end.
The CHMP decision is based on positive data from two late-stage clinical studies – CADZENA and CARDINAL – which evaluated Enjaymo in adult patients with CAD. While the CADZENA study evaluated the drug in patients without a recent history of blood transfusion in the past six months, the CARDINAL study evaluated the drug in patients with a history of blood cell transfusion.
In the year so far, shares of Sanofi have declined 18.5% compared with the industry’s 3.3% fall.
Image Source: Zacks Investment Research
CAD is a rare type of hemolytic anemia (i.e., breakdown of red blood cells) wherein the body’s immune system mistakenly destroys healthy red blood cells. A monoclonal antibody, Enjaymo is designed to target and inhibit C1 protein, which is a part of the innate immune system. This, in turn, prevents the destruction of healthy red blood cells.
Enjaymo was approved by the FDA in early February as the first and currently the only approved treatment for red blood cell transfusion due to hemolysis in adults with CAD.
In a separate press release, Sanofi announced that the CHMP has also recommended granting marketing authorization to nirsevimab, a long-acting antibody. The antibody has been developed for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. The antibody has been developed in collaboration with AstraZeneca (AZN - Free Report) . If approved, the product is expected to be marketed under the trade name Beyfortus.
The CHMP’s endorsement is based on data from multiple studies, which were part of the Beyfortus clinical development program. These studies achieved their primary endpoint and showed a consistent drug safety profile in study participants.
Sanofi and AstraZeneca entered into an agreement in 2017 to develop and commercialize Beyfortus. Per the terms of the agreement, AstraZeneca will be responsible for manufacturing and development activities, while SNY will be responsible for commercialization of the same once it receives approval.
Sanofi Price
Sanofi price | Sanofi Quote
Zacks Rank & Stock to Consider
Sanofi currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are Kamada and Morphic (MORF - Free Report) , which sports 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 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 27.7% in the year-to-date period.
The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 39.8% 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%.