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Novo Nordisk's (NVO) Wegovy Positive in Cardiovascular Study
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Novo Nordisk (NVO - Free Report) announced positive primary results from the late-stage SELECT study at the American Heart Association annual Scientific Sessions in Philadelphia, which are suggestive of Wegovy’s potential in cardiovascular disease (“CVD”) apart from obesity.
The SELECT study is a phase III cardiovascular outcomes study evaluating the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established CVD and overweight or obesity without diabetes.
Wegovy delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (“MACE”), with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (“BMI”). Results showed Wegovy improved cardiovascular outcomes in at-risk patients with a BMI of 27 and above with established CVD without diabetes.
Results also showed that the beneficial effects in MACE risk reduction were evident soon after treatment initiation with Wegovy suggesting an effect of semaglutide 2.4 mg beyond just weight loss.
Top-line results from the study reported earlier showed that semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in MACE over a period of up to five years versus placebo.
Since obesity-related cardiovascular deaths have increased significantly, the three-point MACE risk reduction observed in SELECT suggests the potential of Wegovy as a new option in obesity treatment.
Additional analyses of the three components in MACE indicated that the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared with placebo, the risk of cardiovascular death was reduced by 15% and the risk of non-fatal stroke was reduced by 7% compared with placebo.
The confirmatory secondary endpoints showed that the risk of composite heart failure events, comprising cardiovascular death, urgent heart failure visits and hospitalizations, reduced by 18% compared with placebo and the risk of death from any cause was reduced by 19% compared with placebo.
The supportive secondary endpoints also showed beneficial effects of semaglutide 2.4 mg on other cardiovascular risk factors, including lowering blood pressure, cholesterol and blood sugar levels. Participants in the trial who received semaglutide lost an average of 9.4% of total body weight, which was sustained throughout the study even though the trial was not designed as a weight loss study.
Shares of Novo Nordisk have rallied 49.5% year-to-date compared with the industry’s growth of 3.3%.
Image Source: Zacks Investment Research
Novo Nordisk’s earnings and revenues beat estimates in the third quarter of 2023 on the back of higher Diabetes and Obesity care sales. Ozempic and Rybelsus are expected to drive growth in the upcoming quarters as well. Wegovy and Saxenda, too, have witnessed strong uptake so far, contributing to the top line.
NVO continues to expand its supply capacity for Wegovy, post its relaunch in the United States as well as in other geographies. NVO also announced plans to invest more than DKK 42 to expand existing manufacturing facilities in Kalundborg, Denmark.
The obesity market has garnered much interest lately, giving impetus to drugs like Wegovy and Eli Lilly’s (LLY - Free Report) Mounjaro (tirzepatide), among others.
LLY’s Mounjaro, a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist, was approved in 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The FDA has recently approved tirzepatide, under the brand name Zepbound, for adults with obesity or those who are overweight and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 24.1% in the year so far.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in all of the last four quarters. The company has delivered an earnings surprise of 67.19% on average.
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Novo Nordisk's (NVO) Wegovy Positive in Cardiovascular Study
Novo Nordisk (NVO - Free Report) announced positive primary results from the late-stage SELECT study at the American Heart Association annual Scientific Sessions in Philadelphia, which are suggestive of Wegovy’s potential in cardiovascular disease (“CVD”) apart from obesity.
The SELECT study is a phase III cardiovascular outcomes study evaluating the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established CVD and overweight or obesity without diabetes.
Wegovy delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (“MACE”), with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (“BMI”). Results showed Wegovy improved cardiovascular outcomes in at-risk patients with a BMI of 27 and above with established CVD without diabetes.
Results also showed that the beneficial effects in MACE risk reduction were evident soon after treatment initiation with Wegovy suggesting an effect of semaglutide 2.4 mg beyond just weight loss.
Top-line results from the study reported earlier showed that semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in MACE over a period of up to five years versus placebo.
Since obesity-related cardiovascular deaths have increased significantly, the three-point MACE risk reduction observed in SELECT suggests the potential of Wegovy as a new option in obesity treatment.
Additional analyses of the three components in MACE indicated that the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared with placebo, the risk of cardiovascular death was reduced by 15% and the risk of non-fatal stroke was reduced by 7% compared with placebo.
The confirmatory secondary endpoints showed that the risk of composite heart failure events, comprising cardiovascular death, urgent heart failure visits and hospitalizations, reduced by 18% compared with placebo and the risk of death from any cause was reduced by 19% compared with placebo.
The supportive secondary endpoints also showed beneficial effects of semaglutide 2.4 mg on other cardiovascular risk factors, including lowering blood pressure, cholesterol and blood sugar levels. Participants in the trial who received semaglutide lost an average of 9.4% of total body weight, which was sustained throughout the study even though the trial was not designed as a weight loss study.
Shares of Novo Nordisk have rallied 49.5% year-to-date compared with the industry’s growth of 3.3%.
Image Source: Zacks Investment Research
Novo Nordisk’s earnings and revenues beat estimates in the third quarter of 2023 on the back of higher Diabetes and Obesity care sales. Ozempic and Rybelsus are expected to drive growth in the upcoming quarters as well. Wegovy and Saxenda, too, have witnessed strong uptake so far, contributing to the top line.
NVO continues to expand its supply capacity for Wegovy, post its relaunch in the United States as well as in other geographies. NVO also announced plans to invest more than DKK 42 to expand existing manufacturing facilities in Kalundborg, Denmark.
The obesity market has garnered much interest lately, giving impetus to drugs like Wegovy and Eli Lilly’s (LLY - Free Report) Mounjaro (tirzepatide), among others.
LLY’s Mounjaro, a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist, was approved in 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The FDA has recently approved tirzepatide, under the brand name Zepbound, for adults with obesity or those who are overweight and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off.
Zacks Rank and Other Stocks to Consider.
Novo Nordisk currently has a Zacks Rank #2 (Buy).
A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 24.1% in the year so far.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in all of the last four quarters. The company has delivered an earnings surprise of 67.19% on average.