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Novo Nordisk (NVO) Gets Positive CHMP Opinion for Wegovy
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Novo Nordisk A/S (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and recommended marketing authorization to Wegovy, a once-weekly semaglutide 2.4 mg injection for chronic weight management in adults with obesity.
The positive CHMP opinion was based on data from the phase IIIa STEP program. Data from the same showed that treatment with Wegovy led to an average weight loss of 17-18% which was sustained over 68 weeks in people suffering from obesity or those who are overweight without type II diabetes. Also, Wegovy demonstrated a safe and well-tolerated profile.
Final marketing authorization for Wegovy is expected in around two months from the European Commission. The company plans to launch Wegovy in the European market in the second half of 2022.
Shares of Novo Nordisk have rallied 62.4% so far this year compared with the industry’s growth of 16.9%.
Image Source: Zacks Investment Research
We remind investors that, in June 2021, the FDA approved semaglutide as a weekly 2.4-mg injection for weight management for people suffering from obesity.
The GLP-1 product is marketed under the brand name Wegovy for chronic weight management in adults suffering from obesity (initial BMI≥30 kg/m2) or those who are overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity, such as high blood pressure, heart disease or type 2 diabetes.
Subsequently, in September 2021, the Medicines and Health products Regulations Agency in the United Kingdom approved Wegovy for the treatment of adults with obesity or those who are overweight.
Novo Nordisk has a strong presence in the Diabetes care market, with one of the broadest diabetes portfolios in the industry. The company has improved its global diabetes value market share over the past 12 months from 29.2% to 29.9%, in line with the aspiration of strengthening the Diabetes care leadership globally.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Better-ranked stocks in the healthcare sector include Endo International plc , GlaxoSmithKline plc (GSK - Free Report) and bluebird bio, Inc. (BLUE - Free Report) . While Endo International carries a Zacks Rank #1 (Strong Buy), GlaxoSmithKline and bluebird bio carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo International’s earnings estimates have been revised 24% upward for 2021 and 10.3% upward for 2022 over the past 60 days.
Endo International’s earnings have surpassed estimates in each of the trailing four quarters.
GlaxoSmithKline’s earnings estimates have been revised 9.7% upward for 2021 and 6.2% upward for 2022 over the past 60 days. The stock has rallied 17.4% year to date.
GlaxoSmithKline’s earnings have surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.
bluebird bio’s loss per share estimates have narrowed 10.4% for 2021 and 24.1% for 2022, over the past 60 days.
Earnings of bluebird bio have surpassed estimates in only one of the trailing four quarters, and missed the sameon the other three occasions.
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Novo Nordisk (NVO) Gets Positive CHMP Opinion for Wegovy
Novo Nordisk A/S (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and recommended marketing authorization to Wegovy, a once-weekly semaglutide 2.4 mg injection for chronic weight management in adults with obesity.
The positive CHMP opinion was based on data from the phase IIIa STEP program. Data from the same showed that treatment with Wegovy led to an average weight loss of 17-18% which was sustained over 68 weeks in people suffering from obesity or those who are overweight without type II diabetes. Also, Wegovy demonstrated a safe and well-tolerated profile.
Final marketing authorization for Wegovy is expected in around two months from the European Commission. The company plans to launch Wegovy in the European market in the second half of 2022.
Shares of Novo Nordisk have rallied 62.4% so far this year compared with the industry’s growth of 16.9%.
We remind investors that, in June 2021, the FDA approved semaglutide as a weekly 2.4-mg injection for weight management for people suffering from obesity.
The GLP-1 product is marketed under the brand name Wegovy for chronic weight management in adults suffering from obesity (initial BMI≥30 kg/m2) or those who are overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity, such as high blood pressure, heart disease or type 2 diabetes.
Subsequently, in September 2021, the Medicines and Health products Regulations Agency in the United Kingdom approved Wegovy for the treatment of adults with obesity or those who are overweight.
Novo Nordisk has a strong presence in the Diabetes care market, with one of the broadest diabetes portfolios in the industry. The company has improved its global diabetes value market share over the past 12 months from 29.2% to 29.9%, in line with the aspiration of strengthening the Diabetes care leadership globally.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Better-ranked stocks in the healthcare sector include Endo International plc , GlaxoSmithKline plc (GSK - Free Report) and bluebird bio, Inc. (BLUE - Free Report) . While Endo International carries a Zacks Rank #1 (Strong Buy), GlaxoSmithKline and bluebird bio carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo International’s earnings estimates have been revised 24% upward for 2021 and 10.3% upward for 2022 over the past 60 days.
Endo International’s earnings have surpassed estimates in each of the trailing four quarters.
GlaxoSmithKline’s earnings estimates have been revised 9.7% upward for 2021 and 6.2% upward for 2022 over the past 60 days. The stock has rallied 17.4% year to date.
GlaxoSmithKline’s earnings have surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.
bluebird bio’s loss per share estimates have narrowed 10.4% for 2021 and 24.1% for 2022, over the past 60 days.
Earnings of bluebird bio have surpassed estimates in only one of the trailing four quarters, and missed the sameon the other three occasions.