Latest news with #Amycretin
Yahoo
2 hours ago
- Health
- Yahoo
Novo Nordisk plans to start late-stage trials of obesity drug amycretin next year
(Reuters) -Novo Nordisk said on Thursday it plans to start late-stage trials of its experimental weight-loss drug, amycretin, in injection and oral forms during the first quarter of 2026 for adults who are overweight or obese. The decision to advance the trials is based on feedback received from regulatory authorities in interactions following the end of its mid-stage trials, the company said. Amycretin, the Danish drugmaker's next-generation obesity drug, has a dual-mode action. Like its popular weight-loss drug Wegovy, amycretin not only mimics the gut hormone GLP-1, but also the effect of a hunger-suppressing pancreatic hormone called amylin. Weekly injections of the drug helped patients lose 22% of their weight in 36 weeks, according to early-stage trial results published in January. Last year, the pill version helped patients lose up to 13.1% of their weight after 12 weeks in early-stage trial. Novo is also developing another two-drug combination, known as CagriSema, which, too, targets the amylin hormone. The company has launched a new late-stage trial for the drug, the U.S. government's trial database showed this week, as it tries to reassure the market of its potential after disappointing data from two previous studies. Novo had positioned CagriSema as a more potent successor to its blockbuster obesity treatment Wegovy, but lower-than-expected weight loss stoked worries that Eli Lilly may be gaining an edge over the company in the market for such drugs.
Yahoo
2 days ago
- Business
- Yahoo
Is Novo Nordisk's Next Generation Obesity Pipeline a Game Changer?
Novo Nordisk NVO has seen strong momentum in recent years, driven by the commercial success of its blockbuster semaglutide products, Wegovy (obesity) and Ozempic (diabetes). Building upon this success, NVO is developing several next-generation candidates in its pipeline, especially targeting the lucrative U.S. market. The most advanced candidate in Novo Nordisk's pipeline is CagriSema, a fixed-dose combination of a long-acting amylin analogue and Wegovy. CagriSema met the primary endpoint of statistically significant weight loss in two late-stage studies. The company is already planning its regulatory submission in 2026. Novo Nordisk is also developing an early-stage candidate, Amycretin, a unimolecular GLP-1 and amylin receptor agonist, which had outperformed Wegovy in a phase I study. Novo Nordisk has also been pursuing licensing deals and acquisitions to further expand its obesity pipeline. In 2023, it acquired Inversago Pharmaceuticals, which added a small-molecule oral CB1 inverse agonist, monlunabant, to its pipeline. Recently, Novo Nordisk signed a $2.2 billion deal with Septerna for developing and commercializing oral small-molecule medicines for treating obesity, type II diabetes (T2D) and other cardiometabolic diseases. Eli Lilly LLY is NVO's fierce competitor in the obesity space, which markets its tirzepatide medicines as Mounjaro for T2D and Zepbound for obesity. Like NVO, LLY is also evaluating several next-generation weight loss candidates. Lilly recently reported first phase III success of its oral GLP-1 candidate, orforglipron, which showed significant weight reduction potential in the late-stage study. Regulatory filings for orforglipron are planned in 2025 and 2026. Several other companies, like Viking Therapeutics VKTX, are also making rapid progress in the development of GLP-1-based candidates in their clinical pipeline. Viking Therapeutics' dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. VKTX initiated a mid-stage study on the oral formulation of the candidate earlier this year and is on track to start the late-stage study on the subcutaneous version soon. Year to date, Novo Nordisk shares have plunged 15.5% compared with the industry's decline of 2.3%. The company has also underperformed the sector and the S&P 500 during the same time frame, as seen in the chart below. The stock is currently trading above its 50-day moving average, but below its 200-day moving average. Image Source: Zacks Investment Research Novo Nordisk is trading at a premium to the industry, as seen in the chart below. Going by the price/earnings ratio, the company's shares currently trade at 17.37 forward earnings, which is higher than 14.95 for the industry. However, the stock is trading much below its five-year mean of 29.25. Image Source: Zacks Investment Research Earnings estimates for 2025 have improved from $3.80 to $3.84 per share over the past 60 days. During the same time frame, Novo Nordisk's 2026 earnings per share estimates have improved from $4.60 to $4.64. Image Source: Zacks Investment Research The stock's return on equity on a trailing 12-month basis is 80.95%, which is higher than 33.56% for the large drugmaker industry, as seen in the chart below. Image Source: Zacks Investment Research Novo Nordisk currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Euronews
05-02-2025
- Business
- Euronews
Novo Nordisk shares surge as weight loss treatments boost profits
Europe's largest pharmaceutical firm, Novo Nordisk, reported fourth-quarter earnings that surpassed analysts' expectations. The company's shares jumped more than 6% at the market open in Europe following the results. Its stock remains flat in year-to-date performance. However, the company expects slower growth in 2025, likely due to increasing competition in the weight-loss market, particularly from its US rival, Eli Lilly. Profit Beats Expectations in the Fourth Quarter Novo Nordisk's operating profit rose 37% to 36.7 billion Danish kroner (€4.92 billion), compared to the estimated 33.6bn DKK (€4.5bn). Full-year operating profit increased by 25% (26% in constant currency) in 2024 to 128.3bn DKK (€17.2bn), with sales in diabetes and obesity care rising by 26%, mainly driven by GLP-1 diabetes sales growth of 21%. The firm's most popular weight-loss drug, Wegovy, posted a 107% year-on-year growth in sales to 19.87bn Danish kroner (€2.66bn) in the fourth quarter, although slightly missing expectations. However, the annual growth rate slowed from 35.6% in 2023 and 27.6% in 2022. Its net profit margin also declined to 34.8% in 2024 from 36% in the previous year. Investors are focused on the company's next-generation weight-loss drugs, as the patent for its blockbuster drug Wegovy is set to expire in the early 2030s. Recently, Novo Nordisk revealed trial results for two new obesity drugs, CagriSema and Amycretin. The former disappointed investors with less-than-projected weight loss, resulting in a 20% intraday plunge in its share price. However, the latter provided positive results, reassuring investors about its growth prospects. Demand for weight-loss drugs surged throughout 2024, outpacing supply for most of the year. In December, Novo Holdings, an investment foundation of Novo Nordisk, acquired three manufacturing sites in Catalent to expand its production capacity. CEO Lars Fruergaard Jørgensen commented: "We are pleased with the performance in 2024, where 26% sales growth reflects that more than 45 million people are now benefiting from our treatments. Further, we completed the acquisition of the three Catalent sites, and during the year, we progressed our R&D pipeline, including obesity projects such as CagriSema and Amycretin. In 2025, we will continue our focus on commercial execution, on the progression of our early and late-stage R&D pipeline, and on the expansion of our production capacity." A Softened 2025 Outlook Novo Nordisk expects a slower growth of between 16% and 24% at constant currency in 2025, with the mid-point marking the lowest in three years. The softened outlook suggests that the weight-loss drug market may face a slowdown while competition intensifies globally. Eli Lilly's corresponding weight-loss drugs to Novo Nordisk's obesity drug Wegovy and diabetes treatment Ozempic are Zepbound and Mounjaro, positioning the firm as a major rival to the Danish pharmaceutical giant. Eli Lilly recently released the latest trial results for its next-generation drug, retatrutide, showing an average weight reduction of 24.4% over 48 weeks, compared to 22% weight loss over 36 weeks for Novo Nordisk's Amycretin. Additionally, Novo Nordisk's mounting spending on research and development may also squeeze its profit margin. The company's R&D costs, primarily comprising employee costs and clinical trial expenses, accelerated in 2024, rising by 48% annually compared to a 35% increase in 2023.
Yahoo
27-01-2025
- Business
- Yahoo
NVO Stock Rises as New Obesity Drug Shows Superior Weight Loss
Shares of Novo Nordisk NVO gained 8.5% on Friday after the company announced positive top-line data from an early to mid-stage study of its investigational candidate, amycretin, in 125 overweight/obese patients. Amycretin is NVO's unimolecular GLP-1 and amylin receptor agonist intended for once-weekly subcutaneous administration. The phase Ib/IIa study evaluated the safety, tolerability, pharmacokinetics and proof-of-concept of three doses of amycretin in obesity patients for a total treatment duration of up to 36 weeks. Per Novo Nordisk, the study's primary safety endpoint was met as amycretin demonstrated a safety profile consistent with incretin-based therapies. Treatment-related adverse events were mostly mild to moderate in severity. NVO shares have plunged 21.7% in the past three months compared with the industry's 12.2% decline. Image Source: Zacks Investment Research Analysis of the study data, assuming all people adhered to treatment, revealed that patients starting with a mean baseline weight of 92.7 kg experienced an estimated weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22% on 20mg (36 weeks) of amycretin compared with a gain in body weight of approximately 1.9%, 2.3% and 2.0% in patients treated with placebo, respectively. Based on such encouraging results, the company is currently planning further clinical development of the candidate in adults with overweight or obesity. We would like to remind the investors that in 2024, Novo Nordisk announced that an oral formulation of amycretin showed faster weight loss than its blockbuster weekly injection for chronic weight management, Wegovy (semaglutide), in a phase I study. Per the data, patients receiving the highest dose of amycretin experienced a 13.1% reduction in body weight after 12 weeks, while those receiving the low dose lost around 10.4%. In stark contrast, Wegovy only showed a weight loss of around 6% after 12 weeks and around 15% after 68 weeks in clinical studies. Amycretin outperformed Wegovy due to the differences in the mechanisms of action of the drugs. Wegovy contains semaglutide, which only targets a hormone called GLP-1 to trigger weight loss. However, amycretin targets GLP-1, as well as a second hormone called amylin. Notably, amylin originates in the pancreas and is responsible for reducing food intake by delaying stomach emptying and decreasing blood glucose levels, leading to the reduction of body weight. Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote Novo Nordisk currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. In the past 30 days, Castle Biosciences' earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $ 1.70. In the past three months, shares of Castle Biosciences have plunged 18.4%. CSTL's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%. In the past 30 days, estimates for BioMarin Pharmaceutical's 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 12%. BMRN's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%. In the past 30 days, estimates for Alnylam Pharmaceuticals' 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 40 cents. In the past three months, shares of Alnylam Pharmaceuticals have lost 2.8%. ALNY's earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
Yahoo
27-01-2025
- Business
- Yahoo
Novo Nordisk shares surge on results of new obesity drug trial
Europe's largest pharmaceutical firm, Novo Nordisk, revealed positive trial results for its next-generation obesity drug, amycretin, marking a major step in its competition within the increasingly heated weight-loss drug market, particularly against its US rival Eli Lilly. The trial results showed that patients taking the highest dose of 20 milligrams achieved an estimated body weight loss of 22% over 36 weeks, compared to a 22.5% weight loss achieved by Lilly's obesity treatment Zepbound over 72 weeks. The latest trial results of Lilly's next-generation drug, retatrutide, demonstrated an average weight reduction of 24.4% over 48 weeks. Novo Nordisk's shares rose by as much as 14% during Friday's trading before paring gains to close 7.13% higher in Copenhagen. Meanwhile, Eli Lilly's stocks dipped 1.2% at the US market open but later recovered, closing up 2.45% on the day. Despite Friday's rally, Novo Nordisk's shares have underperformed, falling by 14% over the past 12 months, while Eli Lilly's stock has surged by 24% during the same period. On 21 December of last year, the Danish pharmaceutical company experienced a 21% plunge in its share price following disappointing trial results for its new obesity drug, CagriSema. Amycretin is considered as Novo Nordisk's most competitive treatment in its weight-loss pipeline for obesity and type-2 diabetes, as the patent for its blockbuster drug Wegovy is set to expire in the early 2030s. 'We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,' said Ematin Lange, executive vice president for development at Novo Nordisk. Amycretin represents an advancement over existing treatments, mimicking both the glucagon-like peptide-1 (GLP-1) hormone and a hormone called amylin to enhance feelings of satiety and regulate blood sugar levels. In comparison, Novo Nordisk's current obesity drug, Wegovy, focuses on GLP-1, which influences fullness and reduces food intake. The company's other well-known drug, Ozempic, specialises in treating diabetes. According to Novo Nordisk, the trial investigated once-weekly subcutaneous injections of amycretin in 125 participants. Results indicated an estimated body weight loss of 9.7% with a 1.25-milligram dose over 20 weeks, 16.2% with 5 milligrams over 28 weeks, and 22.1% with 20 milligrams over 36 weeks. The most common side effects were gastrointestinal, with the vast majority mild to moderate in severity. Novo Nordisk plans further clinical development of amycretin for adults with overweight or obesity, following these promising results. In October, Novo Nordisk reported robust third-quarter earnings, with Wegovy sales up 79% year-on-year. The company is scheduled to release its fourth-quarter and full-year earnings results on 5 February. Despite the positive trial results, Novo Nordisk faces mounting competition in the field. Earlier this month, Eli Lilly CEO David Ricks stated in a Bloomberg TV interview that the company's experimental weight-loss pill, orforglipron, could receive regulatory approval as early as this year. Oral treatments, such as orforglipron, offer greater convenience than injections and are more cost-effective to manufacture. In a mid-stage trial, orforglipron showed weight loss of 14.7% over 36 weeks. Novo Nordisk is also developing amycretin as a once-daily pill, with trial results indicating a 13.1% weight reduction. However, this formulation was associated with numerous side effects. Separately, trials for Novo Nordisk's oral semaglutide showed an average weight loss of 15% over 68 weeks. Sign in to access your portfolio
