Core Insights - The OASIS 4 phase 3 trial demonstrated that oral semaglutide 25 mg (Wegovy® in a pill) achieved an average weight loss of 16.6% over 64 weeks, significantly outperforming the placebo group, which saw only 2.7% weight loss [1][3] - The trial included 307 adults with obesity or overweight and showed that 34.4% of participants on oral semaglutide lost 20% or more of their body weight, compared to 2.9% for placebo [1][3] - Oral semaglutide also improved cardiovascular risk factors and daily activity levels, aligning with previous results from injectable Wegovy® [1][3] Company Insights - Novo Nordisk is preparing for the potential FDA approval of oral semaglutide, with production already underway in the US to meet anticipated demand [2][3] - The company aims to address the low current usage of obesity medications in the US, where less than 2% of individuals with obesity receive treatment [1][3] - Novo Nordisk's chief scientific officer highlighted the importance of patient preference for oral treatments, suggesting that oral semaglutide could increase treatment initiation among those currently untreated [1][3] Industry Insights - The OASIS 4 trial results indicate a significant advancement in obesity treatment options, particularly for oral GLP-1 therapies, which have not been previously approved for weight management [3][6] - Obesity is recognized as a complex disease requiring long-term management, influenced by various factors beyond individual willpower [5][6] - The introduction of oral semaglutide could reshape the landscape of obesity treatment, potentially increasing access and adherence among patients [1][3]

Core Insights - The OASIS 4 phase 3 trial demonstrated the efficacy and safety of oral semaglutide 25 mg (Wegovy in a pill), showing significant weight loss and potential as a new treatment option for obesity management [1][5][7] Efficacy of Oral Semaglutide - Participants adhering to treatment lost an average of 16.6% of their body weight compared to 2.7% for placebo over 64 weeks, with 34.4% achieving a weight loss of 20% or more [2][3] - Even with varying adherence, participants on oral semaglutide still experienced an average weight loss of 13.6% versus 2.2% for placebo, with 29.7% losing 20% or more [3][7] Safety and Tolerability - The safety profile of oral semaglutide was consistent with injectable Wegovy, with mild to moderate gastrointestinal adverse events, primarily nausea (46.6% vs. 18.6% for placebo) and vomiting (30.9% vs. 5.9% for placebo) [4][5] - Serious adverse events occurred in 3.9% of participants on oral semaglutide compared to 8.8% for placebo, reinforcing its safety profile [4][5] Market Potential and FDA Submission - Novo Nordisk has submitted a New Drug Application (NDA) for oral semaglutide, with FDA review expected to be completed by the end of the year, potentially addressing the less than 2% of individuals with obesity currently receiving medication [5][6] - If approved, the oral formulation will be produced in the US, with manufacturing already underway at Novo Nordisk's expanded facility [6] Broader Health Benefits - Oral semaglutide also showed improvements in cardiovascular risk factors and daily physical activity, indicating broader health benefits beyond weight loss [3][7] Industry Context - The introduction of oral semaglutide represents a significant advancement in obesity treatment, as it is the first oral GLP-1 therapy submitted for chronic weight management in the US [7][14] - The obesity epidemic is a complex disease influenced by various factors, and effective long-term management options are crucial for patient care [11]

NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Novo Nordisk A/S (NYSE: NVO) between May 7, 2025 and July 28, 2025, both dates inclusive (the “Class Period”), of the important September 30, 2025 lead plaintiff deadline. SO WHAT: If you purchased Novo Nordisk securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WH ...

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Summary of Novo Nordisk Fireside Chat at EASD Company Overview - **Company**: Novo Nordisk - **Event**: Fireside chat at the 61st edition of EASD in Vienna - **Focus**: Research and Development (R&D) pipeline, particularly in diabetes and obesity Key Points R&D Organization and Strategy - Novo Nordisk has re-merged its research and development organizations to create strategic and scientific synergies, enhancing efficiency and decision-making speed [3][4] - The company remains focused on diabetes and obesity, while also addressing related comorbidities such as cardiovascular and renal diseases [4][5] Pipeline Developments - **Semaglutide**: New data presented at EASD shows a 21% weight loss in obesity treatment, with ongoing regulatory filings in Europe and the U.S. [5][6] - **Oral Semaglutide**: An oral version is under review, with expectations for U.S. regulatory submission in Q4 [6][11] - **CagriSema and Amiglutide**: Upcoming readouts for type 2 diabetes and obesity treatments, with CagriSema expected to show significant results [9][10][13] Clinical Trials and Real-World Evidence - Real-world evidence studies confirm cardiovascular benefits of semaglutide, with a 26% reduction in CV risk in diabetes patients [8][9] - The company emphasizes the importance of flexible titration in clinical trials to reduce dropout rates and improve patient outcomes [42][44] Weight Loss and Patient-Centric Approach - Novo Nordisk recognizes obesity as a complex disease, tailoring treatments to individual patient needs, including options for moderate weight loss with fewer side effects [12][13] - The company aims to maintain muscle strength and functionality during weight loss, with evidence showing that patients do not lose muscle strength with GLP-1 treatments [70][71] Future Directions - The company is exploring the potential of GIP agonists and antagonists in its pipeline, maintaining a curious approach to new biologies [89] - Plans to initiate phase 3 trials for CagriSema and Amiglutide, with a focus on both obesity and diabetes treatment [10][74] Regulatory and Market Considerations - Novo Nordisk is committed to a robust supply chain to ensure full-scale launches of new products, prioritizing patient access [64][65] - The company is aware of the competitive landscape and is focused on differentiating its offerings based on clinical efficacy and safety profiles [56][74] Additional Insights - The company is cautious about the high-risk nature of Alzheimer's trials, acknowledging the challenges in this area [16] - Discussions around the need for active comparator arms in clinical trials highlight the importance of demonstrating superiority or non-inferiority to existing treatments [62] This summary encapsulates the key discussions and insights from the Novo Nordisk Fireside Chat, focusing on their strategic direction, pipeline developments, and commitment to patient-centric care in the diabetes and obesity treatment landscape.

Core Viewpoint - Novo Nordisk is no longer considered a dominant player in the market, as indicated by Berenberg analysts, suggesting a shift in perception regarding the company's market position [1] Company Summary - Analysts from Berenberg have noted that Novo Nordisk's previous status as a major market force has diminished, indicating a potential change in competitive dynamics within the industry [1] Industry Summary - The commentary from Berenberg reflects broader trends in the pharmaceutical industry, where companies may be experiencing shifts in their competitive standings and market influence [1]

Core Insights - Novo Nordisk (NVO) announced positive data from a sub-analysis of its phase III REDEFINE 1 study on cagrilintide, showing significant weight loss in adults with obesity or overweight without diabetes [1][6][8] Company Developments - Cagrilintide, a next-generation injectable long-acting amylin analogue, demonstrated an average body weight reduction of 11.8% (12.5 kg) compared to 2.3% (2.5 kg) with placebo after 68 weeks [3][6] - The sub-analysis indicated that 31.6% of patients treated with cagrilintide achieved at least 15% weight loss, while only 4.7% in the placebo group did [3][4] - Novo Nordisk plans to launch a dedicated phase III RENEW obesity program for cagrilintide in Q4 2025 [6][8] Market Context - The obesity market is projected to expand to $100 billion by 2030, intensifying competition among major players like Eli Lilly and Novo Nordisk [15] - Eli Lilly's tirzepatide-based drugs, Mounjaro and Zepbound, have rapidly gained market share, generating combined sales of $14.7 billion in the first half of 2025 [12][11] - Novo Nordisk is actively developing next-generation obesity candidates and pursuing licensing deals to strengthen its pipeline, including the acquisition of Inversago Pharmaceuticals and a $2.2 billion deal with Septerna [14][13] Competitive Landscape - Other companies, such as Amgen and Viking Therapeutics, are also advancing their GLP-1-based candidates, contributing to the competitive dynamics in the obesity treatment market [15][16][17]

Morning, David. Well, Lily's GLP-1 pill or for Gipron besting Novo's GLP-1 pill in a phase three trial for type 2 diabetes. Now, this was the main goal was diabetes, but they also did look at weight loss.So, at the highest dose, Lily's pill over glyceron lowering blood sugar by 2.2% versus 1.4% for Novo's oral version of simaglutide. Lily's pill delivered weight loss of about 9% versus about 5% for Novos. But there is one really important caveat here and that's that Lily used about half the dose that Novo p ...

Core Insights - Eli Lilly's GLP-1 pill has outperformed Novo Nordisk's GLP-1 pill in a phase three trial for type 2 diabetes, with a focus on both diabetes management and weight loss [1][2] - At the highest dose, Lilly's pill reduced blood sugar by 2.2% compared to 1.4% for Novo's oral version, and achieved a weight loss of approximately 9% versus 5% for Novo's product [2] - Lilly used about half the dose for weight loss compared to what Novo plans to use, which may affect real-world results [2][3] - Novo's pill is already available for diabetes at the tested dose, while it seeks approval for a higher dose to treat obesity [3] - Lilly's top scientist indicated that their drug has exceeded street estimates in three out of four studies, and variability in results is expected but not a primary concern for patients [4]

Core Viewpoint - Novo Nordisk (NVO.US) shares rose over 2.5%, reaching a new high of $58.67 since late July, driven by positive results from a late-stage clinical trial of the new weight-loss drug Cagrilintide [1] Group 1: Clinical Trial Results - Cagrilintide, administered as a once-weekly injection, helped patients achieve an average weight loss of 11.8% after 68 weeks, compared to only 2.3% in the placebo group [1] - The drug demonstrated good tolerability, with the most common side effects being gastrointestinal reactions, mostly mild to moderate in severity [1]