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CHMP Backs Higher-Dose Wegovy as Novo Nordisk Seeks 2026 EU Approval
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Key Takeaways
CHMP issued a positive opinion supporting EU approval of a 7.2 mg dose of Novo Nordisk's Wegovy.
NVO's STEP UP study showed 20.7% average weight loss with 7.2 mg Wegovy versus 17.5% at 2.4 mg.
About one-third of obesity patients on the 7.2 mg dose achieved at least 25% weight loss in the study.
Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the EU approval of a higher dose of its blockbuster obesity injection, Wegovy (semaglutide). NVO expects a final decision from the European Commission early in 2026.
The regulatory filing in the EU seeks approval for a 7.2 mg dose of the drug, which Novo Nordisk claims provides an option for “greater weight loss potential” than what is currently being offered by the available doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg).
Please note that Wegovy is currently approved in the EU for weight management, for reducing major cardiovascular events, easing HFpEF symptoms, and relieving osteoarthritis-related knee pain in obesity patients.
How Effective is NVO’s Higher-Dose Wegovy?
The positive CHMP opinion is 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 33.2% of patients 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 safety and tolerability profile of the higher dose was consistent with that of the approved 2.4 mg dose. 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 the past year, shares of Novo Nordisk have plunged 53.6% against the industry‘s 12.2% growth.
Image Source: Zacks Investment Research
Novo Nordisk has also applied to the EMA, seeking approval for a single-dose delivery device for Wegovy 7.2 mg.
Last month, Novo Nordisk submitted a regulatory filing in the United States seeking approval for Wegovy 7.2 mg to treat obesity. For this filing, Novo Nordisk is seeking an extra-fast review through the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program.
This program is designed to significantly fast-track the review of drugs and biologics addressing serious or life-threatening diseases with high unmet medical needs, reducing the standard review period from 10-12 months (6-8 months in case the drug is granted priority review designation) to just 1-2 months, following the FDA’s acceptance of the filing. The CNPV voucher was granted to the company by the agency earlier in November. The higher dose Wegovy is also currently under regulatory review in the United Kingdom and multiple other geographies.
Competition Heating Up in the Obesity Space
The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity. Novo Nordisk and Eli Lilly (LLY - Free Report) currently dominate this space.
Wegovy directly competes with Eli Lilly’s tirzepatide medicine Zepbound. Like Novo Nordisk, LLY also generates a substantial portion of its revenues from sales of this drug.
NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected soon. Novo Nordisk’s most advanced next-generation obesity candidate is CagriSema injection, a fixed-dose combination of cagrilintide and Wegovy. The company plans to file for its regulatory application in 2026. Novo Nordisk is currently gearing up to advance another next-generation candidate, amycretin, for weight management into late-stage development, both as an injection and oral pill. The phase III program on amycretin is planned to be initiated during the first quarter of 2026.
Eli Lilly is investing broadly in next-generation drugs and is currently developing a range of oral and injectable medications with different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule and retatrutide, a GGG tri-agonist. LLY remains on track to submit regulatory filings for orforglipron in obesity soon, setting up the timeline for a potential launch next year. Like Novo Nordisk, Eli Lilly also secured a CNPV from the FDA for orforglipron earlier in November.
Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics is developing its dual GIPR/GLP-1 RA, VK2735, both as oral and subcutaneous formulations for the treatment of obesity. In June, VKTX started two late-stage studies evaluating the subcutaneous formulation of VK2735. While one of these studies recently completed enrolment at a rapid pace, Viking Therapeutics expects to complete enrolment in the other study by the first quarter of 2026.
Last week, Structure Therapeutics reported meaningful weight-loss data from the ACCESS clinical program of its investigational candidate, aleniglipron, for treating obesity. Structure Therapeutics is gearing up to initiate late-stage studies of aleniglipron for obesity around mid-2026, pending alignment with the FDA. Shares of NVO and LLY were down following the news, signaling investor concerns amid the intensifying competitive landscape.
NVO’s Zacks Rank
Novo Nordisk currently carries a Zacks Rank #5 (Strong Sell).
Image: Shutterstock
CHMP Backs Higher-Dose Wegovy as Novo Nordisk Seeks 2026 EU Approval
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the EU approval of a higher dose of its blockbuster obesity injection, Wegovy (semaglutide). NVO expects a final decision from the European Commission early in 2026.
The regulatory filing in the EU seeks approval for a 7.2 mg dose of the drug, which Novo Nordisk claims provides an option for “greater weight loss potential” than what is currently being offered by the available doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg).
Please note that Wegovy is currently approved in the EU for weight management, for reducing major cardiovascular events, easing HFpEF symptoms, and relieving osteoarthritis-related knee pain in obesity patients.
How Effective is NVO’s Higher-Dose Wegovy?
The positive CHMP opinion is 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 33.2% of patients 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 safety and tolerability profile of the higher dose was consistent with that of the approved 2.4 mg dose. 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 the past year, shares of Novo Nordisk have plunged 53.6% against the industry‘s 12.2% growth.
Image Source: Zacks Investment Research
Novo Nordisk has also applied to the EMA, seeking approval for a single-dose delivery device for Wegovy 7.2 mg.
Last month, Novo Nordisk submitted a regulatory filing in the United States seeking approval for Wegovy 7.2 mg to treat obesity. For this filing, Novo Nordisk is seeking an extra-fast review through the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program.
This program is designed to significantly fast-track the review of drugs and biologics addressing serious or life-threatening diseases with high unmet medical needs, reducing the standard review period from 10-12 months (6-8 months in case the drug is granted priority review designation) to just 1-2 months, following the FDA’s acceptance of the filing. The CNPV voucher was granted to the company by the agency earlier in November. The higher dose Wegovy is also currently under regulatory review in the United Kingdom and multiple other geographies.
Competition Heating Up in the Obesity Space
The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity. Novo Nordisk and Eli Lilly (LLY - Free Report) currently dominate this space.
Wegovy directly competes with Eli Lilly’s tirzepatide medicine Zepbound. Like Novo Nordisk, LLY also generates a substantial portion of its revenues from sales of this drug.
NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected soon. Novo Nordisk’s most advanced next-generation obesity candidate is CagriSema injection, a fixed-dose combination of cagrilintide and Wegovy. The company plans to file for its regulatory application in 2026. Novo Nordisk is currently gearing up to advance another next-generation candidate, amycretin, for weight management into late-stage development, both as an injection and oral pill. The phase III program on amycretin is planned to be initiated during the first quarter of 2026.
Eli Lilly is investing broadly in next-generation drugs and is currently developing a range of oral and injectable medications with different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule and retatrutide, a GGG tri-agonist. LLY remains on track to submit regulatory filings for orforglipron in obesity soon, setting up the timeline for a potential launch next year. Like Novo Nordisk, Eli Lilly also secured a CNPV from the FDA for orforglipron earlier in November.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
Smaller biotech firms, like Viking Therapeutics (VKTX - Free Report) and Structure Therapeutics (GPCR - Free Report) , are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics is developing its dual GIPR/GLP-1 RA, VK2735, both as oral and subcutaneous formulations for the treatment of obesity. In June, VKTX started two late-stage studies evaluating the subcutaneous formulation of VK2735. While one of these studies recently completed enrolment at a rapid pace, Viking Therapeutics expects to complete enrolment in the other study by the first quarter of 2026.
Last week, Structure Therapeutics reported meaningful weight-loss data from the ACCESS clinical program of its investigational candidate, aleniglipron, for treating obesity. Structure Therapeutics is gearing up to initiate late-stage studies of aleniglipron for obesity around mid-2026, pending alignment with the FDA. Shares of NVO and LLY were down following the news, signaling investor concerns amid the intensifying competitive landscape.
NVO’s Zacks Rank
Novo Nordisk currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.