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Sanofi's (SNY) Rare Anemia Drug Enjaymo Gets EU Approval
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Sanofi (SNY - Free Report) announced that the European Commission has granted approval to Enjaymo (sutimlimab), its C1 protein inhibitor, to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD), a rare type of autoimmune hemolytic anemia.
Enjaymo is now the first and only therapy approved for treating patients with CAD in Europe. The approval was expected, as in September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had recommended the approval of Enjaymo.
Enjaymo’s approval in Europe was based on data from two phase III studies, CADENZA and CARDINAL.
Sanofi stock has declined 12.7% this year so far against the industry’s increase of 4.3%.
Image Source: Zacks Investment Research
In CAD, a patient’s immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis. The disease affects a patient’s quality of life significantly being associated with extreme fatigue and increased risk of thromboembolic events and mortality. Until now the disease was being managed by a combination of cold avoidance, blood transfusions and off-label treatments. In clinical studies, it has been shown that Enjaymo decreases the need for red blood cell transfusion due to hemolysis in adults with CAD.
Enjaymo was approved in the United States in February this year and in Japan in June. The therapy generated sales of €11 million in the first nine months of 2022.
Some better-ranked large drugmakers include Vertex Pharmaceuticals (VRTX - Free Report) , Merck (MRK - Free Report) and Gilead Sciences (GILD - Free Report) , all carrying a Zacks Rank #2 (Buy) at present.
Vertex Pharmaceuticals’ stock has risen 41.1% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while those for 2023 have increased from $15.10 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Merck’s earnings per share estimates for 2022 have increased from $7.31 per share to $7.38 per share, while that for 2023 have increased from $7.21 per share to $7.34 per share in the past 30 days. Merck’s stock is up 33.5% in the year-to-date period.
Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.
Gilead’s earnings per share estimates for 2022 have increased from $6.57 per share to $7.09 per share, while that for 2023 have increased from $6.48 per share to $6.79 per share in the past 30 days. Gilead’s stock is up 15.1% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.
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Sanofi's (SNY) Rare Anemia Drug Enjaymo Gets EU Approval
Sanofi (SNY - Free Report) announced that the European Commission has granted approval to Enjaymo (sutimlimab), its C1 protein inhibitor, to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD), a rare type of autoimmune hemolytic anemia.
Enjaymo is now the first and only therapy approved for treating patients with CAD in Europe. The approval was expected, as in September, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had recommended the approval of Enjaymo.
Enjaymo’s approval in Europe was based on data from two phase III studies, CADENZA and CARDINAL.
Sanofi stock has declined 12.7% this year so far against the industry’s increase of 4.3%.
Image Source: Zacks Investment Research
In CAD, a patient’s immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis. The disease affects a patient’s quality of life significantly being associated with extreme fatigue and increased risk of thromboembolic events and mortality. Until now the disease was being managed by a combination of cold avoidance, blood transfusions and off-label treatments. In clinical studies, it has been shown that Enjaymo decreases the need for red blood cell transfusion due to hemolysis in adults with CAD.
Enjaymo was approved in the United States in February this year and in Japan in June. The therapy generated sales of €11 million in the first nine months of 2022.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Some better-ranked large drugmakers include Vertex Pharmaceuticals (VRTX - Free Report) , Merck (MRK - Free Report) and Gilead Sciences (GILD - Free Report) , all carrying a Zacks Rank #2 (Buy) at present.
Vertex Pharmaceuticals’ stock has risen 41.1% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while those for 2023 have increased from $15.10 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Merck’s earnings per share estimates for 2022 have increased from $7.31 per share to $7.38 per share, while that for 2023 have increased from $7.21 per share to $7.34 per share in the past 30 days. Merck’s stock is up 33.5% in the year-to-date period.
Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.
Gilead’s earnings per share estimates for 2022 have increased from $6.57 per share to $7.09 per share, while that for 2023 have increased from $6.48 per share to $6.79 per share in the past 30 days. Gilead’s stock is up 15.1% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.