Core Viewpoint - A class action securities lawsuit has been filed against Novo Nordisk A/S, alleging securities fraud that negatively impacted investors between May 7, 2025, and July 28, 2025 [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Novo Nordisk made misleading statements regarding its growth potential, particularly underestimating the impact of the personalization exception to the compounded GLP-1 exclusion and overstating the likelihood of patients switching to its branded alternatives [2]. - On July 29, 2025, Novo announced a reduction in its sales and profit outlook, attributing this to lower growth expectations for Wegovy and Ozempic due to competition and the persistent use of compounded GLP-1s [2]. - Following the announcement, Novo's stock price plummeted from $69.00 per share on July 28, 2025, to $53.94 per share on July 29, 2025, marking a decline of approximately 21.83% in one day [2]. Group 2: Legal Proceedings and Participation - Investors who suffered losses during the specified timeframe have until September 30, 2025, to request to be appointed as lead plaintiff in the lawsuit [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, and participation does not require serving as a lead plaintiff [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

That changes were afoot at the Danish weight management treatments' company Novo Nordisk A/S ( NVO ), (NOVO-B.CO) was already evident when its then-CEO, Lars Fruergaard Jørgensen, stepped down in May. But just howManika is a macroeconomist with over 20 years of experience in industries including investment management, stock broking, investment banking. She also runs the profile Long Term Tips [LTT], which focuses on the generational opportunity in the green economy. Her investing group, Green Growth Giants ...

Core Insights - The global GLP-1 market is experiencing significant attention due to its multi-billion-dollar potential, primarily led by Novo Nordisk and Eli Lilly with their respective products targeting type II diabetes and obesity [1] Competitive Landscape - Eli Lilly and Novo Nordisk have intensified competition, with Eli Lilly's orforglipron showing superior results in A1C and body weight reduction compared to Novo Nordisk's Rybelsus, although orforglipron had higher discontinuation rates due to gastrointestinal side effects [2] - Novo Nordisk's Ozempic demonstrated a 23% reduction in the risk of major adverse cardiovascular events (MACE) compared to Eli Lilly's Trulicity, along with a 25% reduction in a broader composite endpoint [4][10] - Novo Nordisk received EU approval to add cardiovascular benefits to the Rybelsus label, with a 14% reduction in MACE, while FDA review for a similar label expansion is pending [5] Financial Performance - Eli Lilly's Mounjaro and Zepbound generated combined sales of $14.7 billion in the first half of 2025, accounting for 52% of the company's total revenues, indicating a significant market share impact on Novo Nordisk [6] - Novo Nordisk's stock has underperformed, losing 28.1% year-to-date compared to the industry's 0.5% growth [8] Stock Valuation and Estimates - Novo Nordisk's shares are trading at a forward price/earnings ratio of 15.43, higher than the industry average of 14.83, but significantly below its five-year mean of 29.25 [12] - Earnings estimates for 2025 have decreased from $3.98 to $3.85 per share, and for 2026 from $4.56 to $4.07 over the past 60 days, indicating a downward trend in expectations [15]

Core Viewpoint - Novo Nordisk's weekly injectable diabetes drug has received EU approval, providing patients with an additional treatment option [1] Group 1: Drug Approval and Composition - The European Medicines Agency's drug review panel recommended the approval of Kyinsu for treating type 2 diabetes patients [1] - The drug is a combination of insulin and semaglutide, the active ingredient in Novo Nordisk's popular weight loss drug Ozempic, and is also known as IcoSema [1] Group 2: Clinical Efficacy - Clinical trials indicate that the drug helps type 2 diabetes patients better control their weight and lower blood sugar levels, outperforming daily insulin injections [1] - The drug is particularly beneficial for patients who struggle to manage diabetes through daily insulin injections [1] Group 3: Regulatory Challenges - The long-acting insulin component of the drug was previously rejected by the U.S. Food and Drug Administration due to the need for more detailed information regarding the manufacturing process and indications for type 1 diabetes [1]

Group 1 - The analyst has over 10 years of experience researching more than 1000 companies across various sectors including commodities and technology [1] - The focus has shifted from writing a blog to creating a value investing-focused YouTube channel, where hundreds of companies have been researched [1] - The analyst expresses a particular interest in metals and mining stocks, while also being comfortable with other industries such as consumer discretionary, REITs, and utilities [1]

Core Viewpoint - Novo Nordisk recently presented a subgroup analysis from the phase 3 clinical trial REDEFINE 1 at the 2025 European Association for the Study of Diabetes (EASD) annual meeting, highlighting the efficacy and safety of cagrilintide for weight management in obese or overweight adults without diabetes [4][6]. Group 1: Clinical Trial Overview - REDEFINE 1 is a 68-week, double-blind, placebo-controlled study involving 3,417 adult participants with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) and at least one weight-related comorbidity, excluding type 2 diabetes [4][6]. - The trial compared the effects of CagriSema (cagrilintide 2.4 mg/semaglutide 2.4 mg combination), cagrilintide monotherapy, semaglutide monotherapy, and placebo [4]. Group 2: Efficacy Results - Cagrilintide demonstrated significant weight loss, with an average reduction of 11.8% (12.5 kg) after 68 weeks, compared to a 2.3% (2.5 kg) reduction in the placebo group [6]. - Approximately 31.6% of participants in the cagrilintide group achieved a weight loss of ≥15%, while only 4.7% in the placebo group did [6]. - Even considering non-compliance, the cagrilintide group still achieved an average weight loss of 11.5% (placebo group 3.0%), with 31.0% of participants losing ≥15% [6]. Group 3: Safety and Tolerability - Cagrilintide was generally well-tolerated, with the most common side effects being gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation, which were mostly transient and mild to moderate [6]. - The discontinuation rate due to nausea was 1.0% in the cagrilintide group compared to 0.1% in the placebo group [6]. - A specialized phase 3 RENEW program is expected to launch in Q4 2025 to further validate the safety and efficacy of cagrilintide in overweight or obese populations [6].

Core Viewpoint - Novo Nordisk's oral semaglutide has shown significant weight loss results comparable to its injectable counterpart Wegovy, with a 16.6% average weight reduction in a 64-week trial, leading to a stock price increase of 5.4% on the announcement day [4][5]. Group 1: Clinical Trial Results - In the Oasis 4 study, patients treated with oral semaglutide experienced an average weight loss of 16.6%, slightly better than the 15% reduction seen with Wegovy in similar populations [4]. - The oral formulation is expected to replicate the efficacy and safety of the injectable version, as confirmed by Novo Nordisk's Chief Scientific Officer [5]. Group 2: Market Competition - The oral GLP-1 market is becoming increasingly competitive, with Eli Lilly's candidate Orforglipron showing a 12.4% average weight loss in a recent trial [6]. - Novo Nordisk emphasizes that its oral semaglutide can achieve approximately 17% weight loss with a lower discontinuation rate due to adverse reactions, suggesting better safety and tolerability [6]. Group 3: Strategic Focus and Pipeline - Novo Nordisk is not only advancing oral semaglutide but also developing next-generation weight loss therapies, including long-acting amylin analog Cagrilintide [8]. - The company is undergoing a strategic transformation, including a workforce reduction of about 9,000 employees to concentrate resources on diabetes and obesity core areas [8].

Group 1: Diabetes Market Overview - Diabetes is a chronic health condition characterized by long-term high blood sugar levels, affecting a significant portion of the global population. In 2021, 537 million adults aged 20-79 were diagnosed with diabetes, projected to rise to 643 million by 2030 [1] - The global diabetes drug market is valued at $88.32 billion in 2024, expected to grow to $1001.48 billion by 2025 and reach $2338.4 billion by 2032, with a compound annual growth rate (CAGR) of 12.7% during the forecast period [1] - The increasing prevalence of diabetes is driving demand for treatment drugs, leading to intensified development efforts by pharmaceutical companies [1] Group 2: Eli Lilly - Eli Lilly's China division merged its Immunology and Oncology divisions into a new "Immunology and Oncology Division," effective October 1, 2025, with a new leader appointed [2] - In the first half of 2025, Eli Lilly's revenue in China reached $917 million, a 19% year-on-year increase, driven by a 1.6-fold increase in sales of GLP-1 drugs [2] - Eli Lilly's total revenue for the first half of 2025 was $28.2862 billion, a 41% increase from the previous year, with diabetes and weight loss drugs contributing nearly half of its revenue [3] Group 3: Novo Nordisk - Novo Nordisk announced a global transformation plan to simplify its organizational structure and refocus resources on growth opportunities in diabetes and obesity [4] - The company plans to cut approximately 9,000 jobs globally, representing about 11% of its workforce, with an expected annual cost saving of 8 billion Danish Krone by the end of 2026 [5] - In the first half of 2025, Novo Nordisk reported revenue of 154.944 billion Danish Krone (approximately 173.7 billion Yuan), an 18% increase at fixed exchange rates, with significant contributions from GLP-1 products [6] Group 4: Merck & Co. - Merck & Co. announced a restructuring of its diabetes division, merging it with other mature product lines into an Entrepreneurial Business Unit, indicating a decline in the diabetes product lifecycle [7] - The company reported total revenue of $31.3 billion for the first half of 2025, a 2% decrease, with a significant drop in revenue from its diabetes products in China [8] - Merck plans to implement a cost-saving initiative aiming to save $3 billion annually by 2027, including a workforce reduction of approximately 6,000 employees [9] Group 5: Sanofi - Sanofi ceased the promotion of its new lipid-lowering drug in China due to global supply issues and strategic adjustments in its cardiovascular market [10] - In the first half of 2025, Sanofi's revenue in China was €1.388 billion (approximately 11.7 billion Yuan), showing a slight growth of 0.1% [10] - Sanofi has shifted its focus from diabetes to immunology and inflammation, attempting to transform from a diabetes giant to a leader in the immunology sector [11]

Core Viewpoint - Novo Nordisk's Ozempic shows a 23% lower risk of heart attack, stroke, and death compared to Eli Lilly's Trulicity, significantly impacting the competitive landscape in diabetes and weight loss medications [1][2]. Group 1: Study Results - A Medicare study involving nearly 60,000 patients indicates that patients using Ozempic have a 23% lower risk of heart-related issues compared to those using Trulicity [2]. - Novo Nordisk presented these findings at the European Association for the Study of Diabetes meeting, highlighting the importance of this data in countering Eli Lilly's market share gains with Mounjaro and Zepbound [2][5]. Group 2: Market Impact - Following the announcement of the study results, Novo Nordisk's stock surged over 7%, marking its largest increase in a month, after a 56% decline over the past year due to various clinical and commercial setbacks [2]. - The competitive landscape is intensifying, with both companies releasing comparative data to persuade healthcare providers to choose their products [5]. Group 3: Ongoing Research and Development - Novo Nordisk is advancing a higher dose of Rybelsus, which has shown stronger weight loss effects and has been approved in Europe for diabetes treatment [6]. - Eli Lilly's Mounjaro has shown similar efficacy to Trulicity in reducing heart-related risks, but this trial is not directly comparable to the Ozempic-Trulicity study, which reflects real-world outcomes [6]. Group 4: Physician Considerations - Physicians are encouraged to consider individual patient circumstances when choosing between Mounjaro and Trulicity, as Mounjaro offers additional benefits such as greater weight loss and improvements in obesity-related conditions [7]. - Novo Nordisk focuses on demonstrating its drugs' effectiveness in real-world settings, including studies on its weight loss injection Wegovy's ability to suppress intrusive food thoughts [7].

NEW YORK, Sept. 18, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Novo Nordisk A/S (NYSE: NVO). Shareholders who purchased shares of NVO during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/novo-nordisk-a-s-loss-submission-form-3/?id=167838&from=3 CLASS PERIOD: May 7, 2025 ...