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CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication
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Key Takeaways
CHMP recommends updating Ozempic's EU label based on positive STRIDE PAD outcomes in T2D patients.
Ozempic showed improved walking capacity in patients with T2D and PAD in the late-stage STRIDE study.
NVO expects EC approval of the PAD label update within two months; FDA review is underway in the U.S.
Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly semaglutide) label be updated to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes study.
Please note that Novo Nordisk’s once-weekly subcutaneous diabetes injection, Ozempic, is already approved in 0.25 mg, 0.5 mg, 1 mg and 2 mg doses for treating type II diabetes (T2D) mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus, established cardiovascular disease and chronic kidney disease.
Subject to a nod by the European Commission (EC) for the PAD indication, Ozempic will have the broadest approved label in the GLP-1 RA class of drugs.
More on the CHMP’s Positive Opinion on Ozempic for PAD
The CHMP’s positive opinion recommending the approval of Ozempic for PAD was based on results from the phase IIIb STRIDE study, which demonstrated an improvement in walking capacity in patients with T2D and PAD. Per Novo Nordisk, Ozempic is the first and only glucose-lowering treatment, demonstrating proven functional benefits in people with T2D and PAD.
Year to date, Novo Nordisk shares have lost 18.9% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
PAD is a form of atherosclerotic cardiovascular disease in which fatty deposits narrow arteries, reducing blood flow to muscles and leading to serious symptoms and reduced quality of life.
Novo Nordisk expects the EC to approve the label expansion of Ozempic for treating PAD within about two months. In the United States, the company has also submitted a regulatory application to the FDA seeking the label expansion of Ozempic for treating PAD. A decision is anticipated in the fourth quarter of 2025.
Regulatory Applications for NVO’s Rybelsus Under Review
Novo Nordisk’s regulatory applications in the United States and the EU, seeking the label expansion of Rybelsus (oral semaglutide) as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE), are currently under review. Decisions from both regulatory authorities are expected in the second half of 2025. Pending approval, Rybelsus could potentially become the first and only oral GLP-1 RA with proven cardiovascular benefits.
Please note that NVO currently markets three approved doses of Rybelsus (3 mg, 7 mg and 14 mg) 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 is approved, offering the same bioequivalence as the original Rybelsus doses for the same indication as in the United States.
The applications seeking Rybelsus’ label expansion are based on the data from the phase III SOUL cardiovascular outcomes study, which earlier met its primary endpoint, demonstrating a statistically significant 14% reduction in MACE for T2D patients treated with the drug compared with placebo.
Semaglutide - NVO’s Growth Engine
NVO’s success in the past few years is underscored by its marketed semaglutide medicines.
The company has a strong presence in the Diabetes care market, with one of the broadest diabetes portfolios in the industry. Its global diabetes value market share as of March-end stands at 33.3%, fueled by Rybelsus, Ozempic and Victoza, putting up a strong performance.
Novo Nordisk’s blockbuster obesity drug, Wegovy (semaglutide), is a significant contributor to its revenues. Additionally, Ozempic sales are also contributing positively to overall revenues.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.57 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.80 to $1.33 during the same period. IMCR stock has gained 5.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 56.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has soared 75.2% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
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CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly semaglutide) label be updated to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes study.
Please note that Novo Nordisk’s once-weekly subcutaneous diabetes injection, Ozempic, is already approved in 0.25 mg, 0.5 mg, 1 mg and 2 mg doses for treating type II diabetes (T2D) mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus, established cardiovascular disease and chronic kidney disease.
Subject to a nod by the European Commission (EC) for the PAD indication, Ozempic will have the broadest approved label in the GLP-1 RA class of drugs.
More on the CHMP’s Positive Opinion on Ozempic for PAD
The CHMP’s positive opinion recommending the approval of Ozempic for PAD was based on results from the phase IIIb STRIDE study, which demonstrated an improvement in walking capacity in patients with T2D and PAD. Per Novo Nordisk, Ozempic is the first and only glucose-lowering treatment, demonstrating proven functional benefits in people with T2D and PAD.
Year to date, Novo Nordisk shares have lost 18.9% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
PAD is a form of atherosclerotic cardiovascular disease in which fatty deposits narrow arteries, reducing blood flow to muscles and leading to serious symptoms and reduced quality of life.
Novo Nordisk expects the EC to approve the label expansion of Ozempic for treating PAD within about two months. In the United States, the company has also submitted a regulatory application to the FDA seeking the label expansion of Ozempic for treating PAD. A decision is anticipated in the fourth quarter of 2025.
Regulatory Applications for NVO’s Rybelsus Under Review
Novo Nordisk’s regulatory applications in the United States and the EU, seeking the label expansion of Rybelsus (oral semaglutide) as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE), are currently under review. Decisions from both regulatory authorities are expected in the second half of 2025. Pending approval, Rybelsus could potentially become the first and only oral GLP-1 RA with proven cardiovascular benefits.
Please note that NVO currently markets three approved doses of Rybelsus (3 mg, 7 mg and 14 mg) 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 is approved, offering the same bioequivalence as the original Rybelsus doses for the same indication as in the United States.
The applications seeking Rybelsus’ label expansion are based on the data from the phase III SOUL cardiovascular outcomes study, which earlier met its primary endpoint, demonstrating a statistically significant 14% reduction in MACE for T2D patients treated with the drug compared with placebo.
Semaglutide - NVO’s Growth Engine
NVO’s success in the past few years is underscored by its marketed semaglutide medicines.
The company has a strong presence in the Diabetes care market, with one of the broadest diabetes portfolios in the industry. Its global diabetes value market share as of March-end stands at 33.3%, fueled by Rybelsus, Ozempic and Victoza, putting up a strong performance.
Novo Nordisk’s blockbuster obesity drug, Wegovy (semaglutide), is a significant contributor to its revenues. Additionally, Ozempic sales are also contributing positively to overall revenues.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank and Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Bayer (BAYRY - Free Report) and Agenus (AGEN - Free Report) . While IMCR currently sports a Zacks Rank #1 (Strong Buy), BAYRY and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.57 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.80 to $1.33 during the same period. IMCR stock has gained 5.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 56.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has soared 75.2% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.