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NVO's Rybelsus Meets Primary Goal in MACE Study for Diabetes Patients
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Novo Nordisk (NVO - Free Report) announced positive top-line data from a late-stage cardiovascular outcomes study that evaluated its oral semaglutide compared with placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE).
The enrolled patient population comprised those with type 2 diabetes (T2D) and established cardiovascular disease and/or chronic kidney disease (CKD). Novo Nordisk further stated that 49% of the enrolled patients received SGLT2i, the standard-of-care therapy, at some point during the study.
Please note that NVO already markets oral semaglutide in the United States under the brand name Rybelsus. It is administered once daily and comes in three approved doses, 3 mg, 7 mg and 14 mg. The drug is indicated for adults with insufficiently controlled T2D to improve glycaemic control (blood sugar levels) as an adjunct to diet and exercise. In the EU, a new formulation with doses of 1.5 mg, 4 mg and 9 mg has been approved, offering the same bioequivalence as the original Rybelsus doses for the same indication in the United States.
Year to date, shares of Novo Nordisk have gained 13.4% compared with the industry’s 19% growth.
Image Source: Zacks Investment Research
NVO’s Rybelsus Shows Superior Efficacy in MACE Study
Per the data readout, the phase III SOUL cardiovascular outcomes study met its primary endpoint, demonstrating a statistically significant 14% reduction in MACE for T2D patients treated with oral semaglutide compared with placebo.
Additionally, oral semaglutide had a safety and tolerability profile consistent with previous studies.
Based on such encouraging findings, Novo Nordisk expects to submit regulatory applications with respective authorities, seeking the label expansion of Rybelsus in both the United States and EU around the turn of the year. The detailed results from the SOUL cardiovascular outcomes study are scheduled to be presented at a medical conference in 2025.
Other Semaglutide Medicines Marketed by Novo Nordisk
Novo Nordisk, a leader in the worldwide diabetes and obesity care market, has been witnessing stellar performance of its GLP-1 agonist, semaglutide. Apart from the oral formulation of the drug sold as Rybelsus, NVO also markets semaglutide as an Ozempic pre-filled pen and as a blockbuster weekly Wegovy injection for chronic weight management. Semaglutide has been the key driver of Novo Nordisk’s stupendous growth in the past few years.
Wegovy is the key top-line contributor for Novo Nordisk. Despite supply challenges, Wegovy is seeing strong prescription trends and is generating impressive revenues and profits. The company is investing heavily to ramp up its production capacity to meet the growing demand. Ozempic sales are also contributing to the top line.
Novo Nordisk is also actively exploring additional uses for semaglutide, including evaluating Wegovy for heart failure in diabetes and obesity patients, and Ozempic as a treatment for T2D and CKD. The company is also studying semaglutide for nonalcoholic steatohepatitis. These efforts could expand the eligible patient base for the drug, pending approval.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share (EPS) have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86, during the same period. Year to date, shares of ANIP have gained 7.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Amicus’ 2024 EPS have increased from 20 cents to 22 cents. EPS estimates for 2025 have increased from 48 cents to 53 cents, during the same period. Year to date, shares of FOLD have lost 15.4%.
Amicus’ earnings beat estimates in three of the four trailing four quarters, missing the mark once, with the average surprise being 23.96%.
In the past 60 days, estimates for Fate’s 2024 loss per share have narrowed from $1.74 to $1.73. Loss per share estimates for 2025 have narrowed from $1.71 to $1.69, during the same period. Year to date, shares of FATE have lost 15.8%.
Fate’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 18.22%.
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NVO's Rybelsus Meets Primary Goal in MACE Study for Diabetes Patients
Novo Nordisk (NVO - Free Report) announced positive top-line data from a late-stage cardiovascular outcomes study that evaluated its oral semaglutide compared with placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE).
The enrolled patient population comprised those with type 2 diabetes (T2D) and established cardiovascular disease and/or chronic kidney disease (CKD). Novo Nordisk further stated that 49% of the enrolled patients received SGLT2i, the standard-of-care therapy, at some point during the study.
Please note that NVO already markets oral semaglutide in the United States under the brand name Rybelsus. It is administered once daily and comes in three approved doses, 3 mg, 7 mg and 14 mg. The drug is indicated for adults with insufficiently controlled T2D to improve glycaemic control (blood sugar levels) as an adjunct to diet and exercise. In the EU, a new formulation with doses of 1.5 mg, 4 mg and 9 mg has been approved, offering the same bioequivalence as the original Rybelsus doses for the same indication in the United States.
Year to date, shares of Novo Nordisk have gained 13.4% compared with the industry’s 19% growth.
Image Source: Zacks Investment Research
NVO’s Rybelsus Shows Superior Efficacy in MACE Study
Per the data readout, the phase III SOUL cardiovascular outcomes study met its primary endpoint, demonstrating a statistically significant 14% reduction in MACE for T2D patients treated with oral semaglutide compared with placebo.
Additionally, oral semaglutide had a safety and tolerability profile consistent with previous studies.
Based on such encouraging findings, Novo Nordisk expects to submit regulatory applications with respective authorities, seeking the label expansion of Rybelsus in both the United States and EU around the turn of the year. The detailed results from the SOUL cardiovascular outcomes study are scheduled to be presented at a medical conference in 2025.
Other Semaglutide Medicines Marketed by Novo Nordisk
Novo Nordisk, a leader in the worldwide diabetes and obesity care market, has been witnessing stellar performance of its GLP-1 agonist, semaglutide. Apart from the oral formulation of the drug sold as Rybelsus, NVO also markets semaglutide as an Ozempic pre-filled pen and as a blockbuster weekly Wegovy injection for chronic weight management. Semaglutide has been the key driver of Novo Nordisk’s stupendous growth in the past few years.
Wegovy is the key top-line contributor for Novo Nordisk. Despite supply challenges, Wegovy is seeing strong prescription trends and is generating impressive revenues and profits. The company is investing heavily to ramp up its production capacity to meet the growing demand. Ozempic sales are also contributing to the top line.
Novo Nordisk is also actively exploring additional uses for semaglutide, including evaluating Wegovy for heart failure in diabetes and obesity patients, and Ozempic as a treatment for T2D and CKD. The company is also studying semaglutide for nonalcoholic steatohepatitis. These efforts could expand the eligible patient base for the drug, pending approval.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Amicus Therapeutics (FOLD - Free Report) and Fate Therapeutics (FATE - Free Report) , each sporting 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 ANI Pharmaceuticals’ 2024 earnings per share (EPS) have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86, during the same period. Year to date, shares of ANIP have gained 7.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Amicus’ 2024 EPS have increased from 20 cents to 22 cents. EPS estimates for 2025 have increased from 48 cents to 53 cents, during the same period. Year to date, shares of FOLD have lost 15.4%.
Amicus’ earnings beat estimates in three of the four trailing four quarters, missing the mark once, with the average surprise being 23.96%.
In the past 60 days, estimates for Fate’s 2024 loss per share have narrowed from $1.74 to $1.73. Loss per share estimates for 2025 have narrowed from $1.71 to $1.69, during the same period. Year to date, shares of FATE have lost 15.8%.
Fate’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 18.22%.