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FDA Approves Novo Nordisk's Higher-Dose Wegovy for Obesity Patients
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Key Takeaways
NVO won accelerated FDA nod for Wegovy HD 7.2 mg for obesity patients, targeting an April 2026 launch.
STEP UP data showed 20.7% weight loss at 72 weeks with 7.2 mg vs 17.5% for 2.4 mg and 2.4% for placebo.
About one-third on Wegovy 7.2 mg lost at least 25% weight. Safety and tolerability matched the 2.4 mg profile.
Novo Nordisk (NVO - Free Report) announced that the FDA has approved Wegovy HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction in the long term. NVO expects to launch Wegovy HD in a single-dose pen in the United States in April 2026.
The FDA granted a Commissioner’s National Priority Voucher for Wegovy HD, expediting its review and highlighting its potential to meet critical patient needs and broader U.S. public health priorities. This marks the first approval of a GLP-1 therapy under the Commissioner’s National Priority Voucher pilot program, which is designed for treatments addressing urgent national health concerns.
The drug is now FDA-approved in the United States in multiple formulations, including a once-daily Wegovy pill (semaglutide 25 mg) and once-weekly Wegovy injections (1.7 mg, 2.4 mg, and 7.2 mg), for weight management, reducing major cardiovascular events and easing HFpEF symptoms in obesity patients. Wegovy HD expands Novo Nordisk’s portfolio and enables the company to tailor treatment options better to meet the diverse needs and preferences of obesity patients.
The 7.2 mg dose of Wegovy is already approved for adults with obesity in the United Kingdom and the EU, alongside the other injectable strengths. Novo Nordisk has also filed regulatory applications for a dedicated semaglutide 7.2 mg single-dose pen across these markets and anticipates decisions in the second half of 2026. The Wegovy pill is also currently under regulatory review for marketing approval in the EU and by other health authorities.
In the past six months, Novo Nordisk shares have plunged 38.9% against the industry’s 13.1% growth.
Image Source: Zacks Investment Research
How Effective is NVO’s Higher-Dose Wegovy?
The accelerated FDA approval is mainly supported by data from the phase III STEP UP study, which showed that obesity patients, who do not have diabetes, receiving a 7.2 mg dose of Wegovy for 72 weeks achieved an average weight loss of 20.7% compared with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.
Novo Nordisk also reported additional analyses from the study, showing that approximately one in three people who took the 7.2 mg dose achieved at least 25% weight loss at 72 weeks compared with 16.7% in the 2.4 mg dose group. Data indicated that most of the weight loss with Wegovy, about 84%, was attributable to fat mass reduction, while muscle function was shown to remain intact. No patients in the placebo arm met this criterion. Per NVO, these substantial weight loss results complement the already established health benefits of Wegovy in its approved indications.
The data package also included results from the phase III STEP UP T2D study, which evaluated Wegovy 7.2 mg in obesity patients with type II diabetes. In this study, treatment with the drug demonstrated a mean weight loss of 14.1%, while 21.3% of patients achieved at least 20% weight loss at 72 weeks. The safety and tolerability profile of the higher dose in both studies was consistent with that of the approved 2.4 mg dose. The most common side effects were usually mild to moderate in severity.
The FDA approval of oral Wegovy in late 2025 marked a major milestone for Novo Nordisk, making it the first GLP-1 RA approved in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option, significantly lowering treatment burden and potentially improving patient adherence. Wegovy pill was subsequently launched in the United States in early January.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.82. CPRX shares have gained 11.3% over the past six months.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ADMA Biologics’ 2026 earnings per share (EPS) have increased from 85 cents to 96 cents. ADMA shares have lost 6.3% over the past six months.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.12. INO shares have plunged 33.8% over the past six months.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.
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FDA Approves Novo Nordisk's Higher-Dose Wegovy for Obesity Patients
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the FDA has approved Wegovy HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction in the long term. NVO expects to launch Wegovy HD in a single-dose pen in the United States in April 2026.
The FDA granted a Commissioner’s National Priority Voucher for Wegovy HD, expediting its review and highlighting its potential to meet critical patient needs and broader U.S. public health priorities. This marks the first approval of a GLP-1 therapy under the Commissioner’s National Priority Voucher pilot program, which is designed for treatments addressing urgent national health concerns.
The drug is now FDA-approved in the United States in multiple formulations, including a once-daily Wegovy pill (semaglutide 25 mg) and once-weekly Wegovy injections (1.7 mg, 2.4 mg, and 7.2 mg), for weight management, reducing major cardiovascular events and easing HFpEF symptoms in obesity patients. Wegovy HD expands Novo Nordisk’s portfolio and enables the company to tailor treatment options better to meet the diverse needs and preferences of obesity patients.
The 7.2 mg dose of Wegovy is already approved for adults with obesity in the United Kingdom and the EU, alongside the other injectable strengths. Novo Nordisk has also filed regulatory applications for a dedicated semaglutide 7.2 mg single-dose pen across these markets and anticipates decisions in the second half of 2026. The Wegovy pill is also currently under regulatory review for marketing approval in the EU and by other health authorities.
In the past six months, Novo Nordisk shares have plunged 38.9% against the industry’s 13.1% growth.
Image Source: Zacks Investment Research
How Effective is NVO’s Higher-Dose Wegovy?
The accelerated FDA approval is mainly supported by data from the phase III STEP UP study, which showed that obesity patients, who do not have diabetes, receiving a 7.2 mg dose of Wegovy for 72 weeks achieved an average weight loss of 20.7% compared with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.
Novo Nordisk also reported additional analyses from the study, showing that approximately one in three people who took the 7.2 mg dose achieved at least 25% weight loss at 72 weeks compared with 16.7% in the 2.4 mg dose group. Data indicated that most of the weight loss with Wegovy, about 84%, was attributable to fat mass reduction, while muscle function was shown to remain intact. No patients in the placebo arm met this criterion. Per NVO, these substantial weight loss results complement the already established health benefits of Wegovy in its approved indications.
The data package also included results from the phase III STEP UP T2D study, which evaluated Wegovy 7.2 mg in obesity patients with type II diabetes. In this study, treatment with the drug demonstrated a mean weight loss of 14.1%, while 21.3% of patients achieved at least 20% weight loss at 72 weeks. The safety and tolerability profile of the higher dose in both studies was consistent with that of the approved 2.4 mg dose. The most common side effects were usually mild to moderate in severity.
The FDA approval of oral Wegovy in late 2025 marked a major milestone for Novo Nordisk, making it the first GLP-1 RA approved in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option, significantly lowering treatment burden and potentially improving patient adherence. Wegovy pill was subsequently launched in the United States in early January.
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 Catalyst Pharmaceuticals (CPRX - Free Report) , ADMA Biologics (ADMA - Free Report) and Inovio Pharmaceuticals (INO - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy), ADMA and INO carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.82. CPRX shares have gained 11.3% over the past six months.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ADMA Biologics’ 2026 earnings per share (EPS) have increased from 85 cents to 96 cents. ADMA shares have lost 6.3% over the past six months.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.12. INO shares have plunged 33.8% over the past six months.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.