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NVO

Novo Nordisk A/S New York Stock Exchange
$79.98
Open: $72.76 High: $73.21 Low: $71.91 Close: $72.83
Range: 2021-01-21 - 2021-01-22
Volume: 1,738,337
Market: Closed
Powered by Finage Stock APIDelayed data
NVO
Novo Nordisk A/S Novo Alle Bagsværd , 2880 http://www.novonordisk.com
Novo Nordisk A/S is a healthcare company. It is engaged in the discovery, development, manufacturing and marketing of pharmaceutical products. The company's business segments include, diabetes and obesity care, and biopharmaceuticals.
  • CEO: Lars Fruergaard Jorgensen
  • Employees: 43,161
  • Sector: Healthcare
  • Industry: Biotechnology
NVO News
Latest news about the NVO
  • Novo Nordisk (NVO) Files for Ozempic's Label Expansion in US

    Novo Nordisk (NVO) submits a label expansion application to the FDA for the existing marketing authorization for Ozempic to include a new dose of 2.0 mg.

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  • Novo Nordisk files for regulatory approval in the US of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes

    Bagsværd, Denmark, 20 January 2021 – Novo Nordisk today announced the submission of a label expansion application to the US Food and Drug Administration (FDA) for the existing marketing authorisation for Ozempic®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic® is currently approved in the US in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. The submission follows the application on 29 December 2020 for label extension to the European Medicines Agency (EMA). The submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared to have safe and well-tolerated profiles. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg. “We are excited about the regulatory submission of semaglutide 2.0 mg to the FDA,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “In the SUSTAIN programme most people achieved the treatment target of HbA1c levels below 7%. However, some patients need treatment intensification and with the 2.0 mg dose, more people with type 2 diabetes will be able to achieve treatment target”. About the SUSTAIN clinical programme The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes. For more information about the SUSTAIN FORTE trial, please read the headline results here About Novo NordiskNovo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube. Further information Media: Anne Margrethe Hauge+45 4442 3450amhg@novonordisk.comMichael Bachner (US)+1 609 664 7308mzyb@novonordisk.com Investors: Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.comValdemar Borum Svarrer+45 3079 0301jvls@novonordisk.comAnn Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.comMark Joseph Root+45 3079 4211mjhr@novonordisk.comKristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Company announcement No 3 / 2021 Attachment PR210120_SUSTAIN_Forte_FDA submission

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  • Novo Nordisk A/S – Share repurchase programme

    Bagsværd, Denmark, 18 January 2021 – On 3 November 2020, Novo Nordisk initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules"). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 5 February 2020. Under the programme initiated 3 November 2020, Novo Nordisk will repurchase B shares for an amount up to DKK 2.7 billion in the period from 4 November 2020 to 1 February 2021. Since the announcement as of 11 January 2021, the following transactions have been made: Number ofB sharesAveragepurchase priceTransactionvalue, DKKAccumulated, last announcement4,615,000 1,967,643,51711 January 2021120,000428.7051,443,72912 January 2021120,000429.5951,551,30013 January 2021120,000426.8151,216,63514 January 2021120,000434.1952,102,33715 January 2021120,000441.6452,996,729Accumulated under the programme5,215,000 2,226,954,247 The details for each transaction made under the share repurchase programme are published on novonordisk.com. With the transactions stated above, Novo Nordisk owns a total of 38,738,659 B shares of DKK 0.20 as treasury shares, corresponding to 1.6% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares. Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12-month period beginning 5 February 2020. As of 15 January 2021, Novo Nordisk has since 5 February 2020 repurchased a total of 38,800,522 B shares at an average share price of DKK 425.00 per B share equal to a transaction value of DKK 16,490,383,717. Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube. Further information Media: Anne Margrethe Hauge+45 3079 3450amhg@novonordisk.comMichael Bachner (US)+1 609 664 7308mzyb@novonordisk.com Investors: Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.comValdemar Borum Svarrer+45 3079 0301jvls@novonordisk.comAnn Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.comMark Joseph Root+45 3079 4211mjhr@novonordisk.comKristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Company announcement No 2 / 2021 Attachment CA_210118_SafeHarbour

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  • Novo Nordisk extends COVID-19 Patient Assistance Program, encourages people facing affordability challenges to visit NovoCare.com

    Today, Novo Nordisk announced the extension of its COVID-19 Patient Assistance Program until June 30, 2021, for those who have lost health insurance coverage because of a change in job status due to the pandemic.

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  • Novo Nordisk (NVO) Files for Ozempic's Label Expansion in EU

    Novo Nordisk (NVO) files for a label expansion of Ozempic in the EU to include a new dose of 2.0 mg.

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  • Novo Nordisk files for EU regulatory approval of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes

    Bagsværd, Denmark, 29 December 2020 – Novo Nordisk today announced the submission of a label extension application to the European Medicines Agency (EMA) for the existing marketing authorisation for Ozempic®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic® is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults. The submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.“Following the announcement of the headline results in November, we have expeditiously prepared the submission file. The submission in the EU represents an important milestone for people living with type 2 diabetes who have poor glycaemic control and need treatment intensification” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "With the 2.0 mg dose, more people with type 2 diabetes will be able to achieve treatment target”.About the SUSTAIN clinical programme The SUSTAIN clinical development programme for once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular outcomes trial, involving more than 11,000 adults with type 2 diabetes.For more information about the SUSTAIN Forte trial, please read the headline results hereAbout Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.Further informationMedia:   Martin Havtorn Petersen+45 3075 5246mhpz@novonordisk.com Ken Inchausti (US)+1 609 240 9429kiau@novonordisk.com     Investors:   Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.com Valdemar Borum Svarrer+45 3079 0301jvls@novonordisk.com Ann Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.com Mark Joseph Root+45 3079 4211mjhr@novonordisk.com Kristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Attachment * PR201229_SUSTAIN_Forte_EU_submission

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  • Novo Nordisk (NVO) Files for Semaglutide Label Expansion in EU

    Novo Nordisk (NVO) files application in Europe for the label expansion of subcutaneous Ozempic (semaglutide) 2.4 mg.

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  • Is NVO A Good Stock To Buy?

    Hedge Funds and other institutional investors have just completed filing their 13Fs with the Securities and Exchange Commission, revealing their equity portfolios as of the end of September. At Insider Monkey, we follow nearly 817 active hedge funds and notable investors and by analyzing their 13F filings, we can determine the stocks that they are […]

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  • Novo Nordisk files for EU regulatory approval of once-weekly semaglutide 2.4 mg for weight management

    Bagsværd, Denmark 18 December 2020 ­– Novo Nordisk today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for weight management. The potential indication is for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.The submission is based on the results from the STEP phase 3a clinical trial programme, which included more than 4,500 adults with obesity or overweight. Across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo. Across the trials in people without diabetes STEP 1, 3 and 4, a weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg. Furthermore, once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common side effects were gastrointestinal and were transient, and mild or moderate in severity.  “We are excited about this regulatory filing following the recent regulatory filing with the FDA in the US,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “It is a milestone for Novo Nordisk but more importantly it represents a new treatment option with the potential to transform the medical management for people living with obesity in Europe”.About obesity and subcutaneous semaglutide 2.4 mg for weight management Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and cancer.Once-weekly subcutaneous semaglutide 2.4 mg is being investigated by Novo Nordisk as a potential treatment for obesity. Semaglutide is an analogue of the human glucagon‑like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake.For more information on the FDA filing for semaglutide 2.4 mg, please read the company announcement hereAbout the STEP clinical programme STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development programme with once-weekly subcutaneous semaglutide 2.4 mg in obesity. The global phase 3a programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.STEP 1 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight. For more information, please read the company announcement hereSTEP 2 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo and once-weekly subcutaneous semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either obesity or overweight. For more information, please read the company announcement hereSTEP 3 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight. For more information, please read the company announcement hereSTEP 4 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have reached the target dose of 2.4 mg after a 20-week run-in. For more information, please read the company announcement hereAbout Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.Further informationMedia:   Mette Kruse Danielsen+45 3079 3883mkd@novonordisk.com Ken Inchausti (US)+1 609 240 9429kiau@novonordisk.com     Investors:   Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.com Valdemar Borum Svarrer+45 3079 0301jvls@novonordisk.com Ann Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.com Mark Joseph Root+45 3079 4211mjhr@novonordisk.com Kristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Company announcement No 78 / 2020 Attachment * PR201218_semaglutide_obesity_EMA_submission

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  • Novo Nordisk to enter phase 3 development in Alzheimer’s disease with oral semaglutide

    Bagsværd, Denmark, 16 December 2020 – Novo Nordisk today announced the decision to enter phase 3 development in Alzheimer’s disease with 14 mg oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. The decision follows evaluation of GLP-1 data from preclinical models, real-world evidence studies, post-hoc analysis of data from large cardiovascular outcomes trials, as well as discussions with regulatory authorities. Novo Nordisk intends to initiate a pivotal phase 3a programme with approximately 3,700 people with early Alzheimer’s disease. The programme is planned for initiation in the first half of 2021 and will investigate the efficacy and safety of once-daily oral semaglutide, compared to placebo. The expected main treatment period in the trials is around two years.“As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3 development of semaglutide within Alzheimer’s disease,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer at Novo Nordisk. “Alzheimer’s disease has been an area of extensive research in the past decades, unfortunately without any major medical breakthroughs. Due to the growing unmet medical need and the increasing evidence of a potential therapeutic role for GLP-1, we will investigate the benefits of oral semaglutide in early Alzheimer’s disease.”Conference call On 16 December at 4 pm CET, corresponding to 10 am EST, a conference call for investors will be held where members of management will elaborate on the decision and provide a brief update on the GLP-1 R&D strategy. Investors will be able to listen in via a link on the investor section of novonordisk.com.About Alzheimer’s disease Alzheimer’s disease represents a rapidly growing public health concern causing significant detrimental consequences to the affected people and their families and has led to substantial and increasing global socioeconomic impact. Worldwide, 70-100 million people are estimated to have early Alzheimer’s disease (mild cognitive impairment and mild dementia stages).   About data from preclinical models, real-world evidence studies and the post-hoc analysis Animal studies highlight the key effects of GLP-1 relevant for Alzheimer’s disease including improved memory function and reduced phospho-tau accumulation. Semaglutide has specifically been shown to reduce measures of neuro-inflammation which may affect cognition and function.Further, real-world evidence from two Danish nationwide registries, the US Truven claims database and the US FDA FAERS database support a potential association between lower risk of dementia following treatment with GLP-1.Finally, in a post-hoc analysis of data from three large cardiovascular outcomes trials conducted by Novo Nordisk (LEADER, SUSTAIN 6 and PIONEER 6), which included 15,820 patients with type 2 diabetes with median follow-up of 3.6 years, a total number of 47 people were identified with development of dementia, of which 32 were on placebo and 15 on GLP-1 (liraglutide or semaglutide). The rate of developing dementia was statistically significantly reduced by 53% in favour of GLP-1.   About oral semaglutide Oral semaglutide (7 mg and 14 mg) is approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in the US, EU and Japan. The approval of Rybelsus® is based on the results from 10 clinical trials which included 9,543 adults with type 2 diabetes. Rybelsus® demonstrated a safe and well-tolerated profile across the clinical trials, with the most common adverse event being mild to moderate nausea which diminished over time.Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.Further informationMedia:   Mette Kruse Danielsen+45 3079 3883mkd@novonordisk.com Ken Inchausti (US)+1 609 240 9429kiau@novonordisk.com     Investors:   Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.com Valdemar Borum Svarrer+45 3079 0301jvls@novonordisk.com Ann Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.com Mark Joseph Root+45 3079 4211mjhr@novonordisk.com Kristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Attachment * PR201216_Alzheimers

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  • The Zacks Analyst Blog Highlights: Alibaba, QUALCOMM, Novo Nordisk, Boeing and Delta Air Lines

    The Zacks Analyst Blog Highlights: Alibaba, QUALCOMM, Novo Nordisk, Boeing and Delta Air Lines

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  • Novo Nordisk Completes Acquisition of Emisphere Technologies for $1.35 Billion

    ROSELAND, N.J., Dec. 08, 2020 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (“Emisphere” or the “Company”) today announced the completion of the previously announced transaction whereby Novo Nordisk A/S (“Novo Nordisk”) (NYSE: NVO) acquired Emisphere, on a cash-free, debt-free basis, for $1.35 billion. The consideration paid was $7.83 per share, which was based on the amount of cash and debt of the Company at closing and approximately 170.9 million fully diluted shares outstanding. As a result of the completion of the merger, Emisphere has become a wholly owned subsidiary of Novo Nordisk. The merger was subject to customary closing conditions, including approval by Emisphere stockholders and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). On November 23, 2020, early termination of the waiting period under the HSR Act was granted. Today, at a special meeting of stockholders, Emisphere’s stockholders approved the adoption of the merger agreement.Simultaneous with the completion of the merger, Novo Nordisk completed its acquisition of the related royalty stream obligations owed to affiliates of MHR Fund Management LLC (“MHR”) for $450 million.“We are very pleased to reach today’s milestone and know Novo Nordisk will guide Emisphere into a promising new era. The Emisphere Board of Directors and its Special Committee are confident that this transaction has delivered substantial value to our stockholders,” said Timothy G. Rothwell, Chairman of Emisphere.“MHR was an early believer in Emisphere and its proprietary Eligen drug delivery technology. Our longstanding support of the company was validated when its partnership with Novo Nordisk resulted in the development of an oral formulation for GLP-1, which we believe will be a transformative drug for the treatment of Type 2 diabetes. We are immensely proud of the pivotal role we have played in Emisphere’s success, culminating in the completion of the company’s transaction with Novo Nordisk, delivering immediate and substantial value to all Emisphere shareholders,” said Mark H. Rachesky, M.D., Founder of MHR and a member of the board of Emisphere.Emisphere is represented by Wachtell, Lipton, Rosen & Katz as legal advisor. Jefferies LLC is acting as the Emisphere Special Committee’s financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP is acting as its legal advisor.About Eligen® Carrier TechnologyEligen® technology enables drug therapies to be provided in a tablet formulation with an absorption-enhancing excipient. Emisphere created Eligen® technology, its proprietary oral drug delivery platform, to facilitate the absorption of small and large molecules without altering their chemical form, biological integrity or pharmacological properties. Notably, the technology enables the transport of therapeutic molecules including large peptides and proteins across biological membranes such as those of the gastrointestinal tract.About Emisphere Technologies Emisphere is a drug delivery company that utilises its proprietary technologies to develop new oral formulations of therapeutic agents. For more information, please visit the Company's website at www.emisphere.com.ContactEmisphere Technologies, Inc. investorrelations@emisphere.comMichelle Pappanastos Argot Partners 212.600.1902 michelle@argotpartners.com

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  • Top Research Reports for Alibaba, QUALCOMM & Novo Nordisk

    Top Research Reports for Alibaba, QUALCOMM & Novo Nordisk

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  • How You Can Profit From the Best-Managed Drugmaker on Earth

    There are an estimated 463 million people in the world with diabetes, only half of whom are diagnosed. The disease is a major cause of stroke, kidney failure, blindness, heart attacks, and lower limb amputation. Just in the U.S., the percentage of people with diabetes has increased from less than 1% in 1960 to an estimated 10% in 2020.

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  • FDA Approves Label Expannsion of Novo Nordisk's (NVO) Saxenda

    Novo Nordisk (NVO) gets FDA approval for an updated label for Saxenda (liraglutide) injection 3 mg.

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  • FDA Approves Label Expansion of Novo Nordisk's (NVO) Saxenda

    Novo Nordisk (NVO) gets FDA approval for an updated label for Saxenda (liraglutide) injection 3 mg.

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  • Novo Nordisk A/S: Rectification

    Bagsværd, Denmark, 7 December 2020 – The Danish Maritime and Commercial High Court has ruled that Novo Nordisk's publication of the press release of 19 September 2019:  "Tresiba® showed an overall lower risk of hypoglycaemia and significantly lower HbA1c when compared to insulin glargine U300 in people with type 2 diabetes" was in violation of the Danish Marketing Practices Act and the Danish Medicines Act. Therefore, Novo Nordisk has been ordered to issue this rectification by which Novo Nordisk withdraws the press release of 19 September 2019.Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.Further informationMedia:   Charlotte Zarp-Andersson+45 3079 7603czpa@novonordisk.com Attachment * Rectification_201207

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  • FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17

    Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda® (liraglutide) injection 3 mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to reduced-calorie meals and increased physical activity. Saxenda® was approved in 2014 for chronic weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity, as an adjunct to a reduced calorie meal plan and increased physical activity.1

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  • Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management

    Bagsværd, Denmark, 4 December 2020 – Novo Nordisk today announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for chronic weight management. A priority review voucher has been applied to the NDA, leading to an anticipated review time of six months from the submission date, according to standard FDA review timelines. The potential indication is for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.The submission is based on the results from the STEP phase 3a clinical trial programme, which included more than 4,500 adults with obesity or overweight. Across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo. Across STEP 1, 3 and 4 a weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg. Furthermore, once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common side effects were gastrointestinal and were transient, and mild or moderate in severity.  “Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease ,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "We are excited about the regulatory filing of semaglutide 2.4 mg in the US and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity."About obesity and subcutaneous semaglutide 2.4 mg for weight management Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and cancer.Once-weekly subcutaneous semaglutide 2.4 mg is being investigated by Novo Nordisk as a potential treatment for obesity. Semaglutide is an analogue of the human glucagon‑like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake.About the STEP clinical programme STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development programme with once-weekly subcutaneous semaglutide 2.4 mg in obesity. The global phase 3a programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.STEP 1 – a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight. For more information, please read the company announcement hereSTEP 2 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo and once-weekly subcutaneous semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either obesity or overweight. For more information, please read the company announcement hereSTEP 3 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight. For more information, please read the company announcement hereSTEP 4 – a 68-week safety and efficacy trial of subcutaneous  semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have reached the target dose of 2.4 mg after a 20-week run-in. For more information, please read the company announcement hereAbout Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.Further informationMedia:   Mette Kruse Danielsen+45 3079 3883mkd@novonordisk.com Ken Inchausti (US)+1 609 240 9429kiau@novonordisk.com     Investors:   Daniel Muusmann Bohsen+45 3075 2175dabo@novonordisk.com Valdemar Borum Svarrer+45 3079 0301jvls@novonordisk.com Ann Søndermølle Rendbæk+45 3075 2253arnd@novonordisk.com Mark Joseph Root+45 3079 4211mjhr@novonordisk.com Kristoffer Due Berg (US)+1 609 235 2989krdb@novonordisk.com Company announcement No 74 / 2020Attachment * PR201204_semglutide_obesity_US_submission

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