Core Insights - Novo Nordisk (NVO) has submitted a new drug application (NDA) to the FDA for CagriSema, a once-weekly injection aimed at reducing excess body weight in adults with obesity or overweight, with a review expected in 2026 [2][7] - CagriSema is a combination of cagrilintide and semaglutide, designed to suppress hunger and enhance fullness, potentially making it the first injectable therapy to combine a GLP-1 RA with an amylin analogue [3][4] - The NDA is supported by significant results from two phase III studies, REDEFINE 1 and REDEFINE 2, showing superior weight loss compared to placebo [4][9] Study Results - In the REDEFINE 1 study, CagriSema achieved an average weight loss of 22.7% compared to 2.3% with placebo, with 40.4% of patients losing 25% or more of their body weight [5][6] - The REDEFINE 2 study reported a mean weight loss of 15.7% with CagriSema versus 3.1% with placebo, with 89.7% of patients achieving at least 5% weight loss [9][10] - Overall, patients treated with CagriSema experienced a mean weight loss of 20.4% regardless of adherence, while the placebo group saw a 3% reduction [6][9] Market Context - Novo Nordisk's growth has been impacted by pricing pressures and competition from Eli Lilly's tirzepatide-based drugs, which have rapidly gained market share [11][12] - Eli Lilly's drugs generated $24.8 billion in sales in the first nine months of 2025, accounting for 54% of its total revenues [13] - To counteract competitive pressures, Novo Nordisk is diversifying its obesity portfolio and developing next-generation candidates, including oral formulations and partnerships for new treatments [14][15]

Core Insights - Novo Nordisk (NVO) is a leading player in the cardiometabolic market, primarily through its semaglutide-based drugs, Ozempic and Wegovy, which have seen slowed sales momentum due to various pressures [1][9] - The competitive landscape is intensifying with smaller biotech firms, such as Structure Therapeutics, making significant advancements in obesity treatments, exemplified by the promising results of their candidate aleniglipron [2][3] - Novo Nordisk is actively developing next-generation obesity treatments and expanding its semaglutide franchise to maintain its market position [5][7] Company Performance - NVO's shares have decreased by 58.5% over the past year, underperforming both the industry and the S&P 500, which grew by 7.1% during the same period [11][13] - The company's current price/earnings ratio stands at 12.73, significantly lower than the industry average of 16.48 and below its five-year mean of 29.25 [14] - Earnings estimates for 2025 and 2026 have declined, with 2025 estimates dropping from $3.66 to $3.58 per share and 2026 estimates from $3.91 to $3.65 [16] Competitive Landscape - Eli Lilly (LLY) is a major competitor, marketing its tirzepatide drugs and investing in various new obesity treatments, including orforglipron and retatrutide, with regulatory applications expected soon [8] - Viking Therapeutics (VKTX) is also progressing in the GLP-1 space with its candidate VK2735, which is being developed in both oral and subcutaneous forms for obesity treatment [9][10]