Latest news with #amycretin
Bloomberg
a day ago
- Business
- Bloomberg
Novo Nordisk Overtakes SAP as Europe's Most Valuable Company
Novo Nordisk A/S reclaimed its position as Europe's most valuable public company, overtaking software developer SAP SE. Shares in the Danish drugmaker climbed as much as 2.3% on Friday after Novo said it plans to advance its experimental weight management treatment amycretin into late-stage development following feedback from regulatory authorities.
Reuters
2 days ago
- Health
- Reuters
Novo Nordisk plans to start late-stage trials of obesity drug amycretin next year
June 12 (Reuters) - Novo Nordisk ( opens new tab 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 mimics the gut hormone GLP-1, but it also mimics the effect of a hunger-suppressing pancreatic hormone called amylin.
The Independent
05-02-2025
- Business
- The Independent
Wegovy obesity drug sales more than double but set to slow
Sales of weight loss drug Wegovy more than doubled in the final three months of 2024, as manufacturer Novo Nordisk predicted growth will slow this year. The Danish pharmaceutical company has become one of Europe's largest companies on the back of soaring demand for its obesity treatments. It revealed that sales of Wegovy, a prescription weight loss injection, surged to 19.9 billion Danish kroner (£2.2 billion) in the fourth quarter of last year, from 9.6 billion kroner (£1.1 billion) a year earlier. Sales of the treatment were up 86% for the year as a whole. The strong sales of Wegovy and fellow weight loss treatment Ozempic helped the company's sales rise 26% for the year to 290 billion kroner (£32 billion). It was ahead of analyst predictions of 288 billion kroner. However, it told shareholders on Wednesday that it expects sales to slow slightly next year, guiding towards a range of between 16% and 24% growth. Lars Fruergaard Jorgensen, president and chief executive, said: 'We are pleased with the performance in 2024, where 26% sales growth reflects that more than 45 million people are now benefitting 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.'
Yahoo
31-01-2025
- Business
- Yahoo
Pharma Stock Roundup: SNY and RHHBY's Q4 Earnings & More
This week, Sanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk's NVO novel obesity medicine, amycretin, showed superior weight loss in a study. Merck MRK announced mixed data from a phase III study on a combination regimen of its blockbuster PD-L1 inhibitor, Keytruda, in gastroesophageal cancer. The FDA granted approval for the expanded use of AstraZeneca AZN and its Japanese partner Daiichi's antibody-drug conjugate, Enhertu, in breast cancer. Here's a recap of the week's most important stories. Sanofi missed estimates for both earnings and sales in the fourth quarter. Sanofi's sales rose 10% on a constant currency rate ('CER') basis, while earnings per share declined 11%. Higher sales of Dupixent and contributions from new products like Altuviiio and Beyfortus were partially offset by lower sales of flu vaccines and Aubagio due to generic competition. Dupixent's sales rose 16% year over year. Total vaccine sales increased 10.8% to €2.2 billion, driven by Beyfortus sales in Europe. Sanofi issued a fresh guidance for 2025. It expects its sales to rise by a mid-to-high single-digit percentage at CER. Sanofi also announced a €5 billion ($5.2 billion) buyback program to be executed in 2025. Sanofi expects earnings to rebound strongly in 2025 with the expectation of low double-digit percentage growth versus 4.1% in 2024. Roche's performance in the fourth quarter and full-year 2024 was strong, driven by high demand for its drugs and diagnostic tests. In 2024, sales grew 7% year over year at constant exchange rates (CER). Core earnings per share rose 7% in 2024. In the fourth quarter, sales rose 9% at CER. Sales in the Pharmaceuticals Division grew 8% in 2024. Vabysmo (eye diseases) was the biggest growth driver of sales, with Phesgo (breast cancer), Ocrevus (multiple sclerosis), and Hemlibra (hemophilia) being the other significant contributors. The Diagnostics division's sales rose 4% year over year. Roche expects total sales to grow in the mid-single-digit range (at CER) in 2025. Core earnings per share are expectedto grow in the high single-digit range at CER. Novo Nordisk announced encouraging data from a phase Ib/IIa study on subcutaneous amycretin, a novel unimolecular GLP-1 and amylin receptor agonist in people who are overweight or obese. Top-line data from the study showed that people treated with amycretin experienced a weight loss of 9.7% for the 1.25 mg dose over 20 weeks. While those treated with 5 mg experienced a weight loss of 16.2% over 28 weeks, the ones given 20 mg lost 22% of their weight over 35 weeks. Patients on placebo experienced an estimated 1.9%, 2.3% and 2.0% body weight gain for the 1.25 mg, 5 mg and 20 mg doses, respectively. Amycretin works by a different mechanism from NVO's popular obesity drug, Wegovy. Wegovy mimics the GLP-1 hormone while amycretin mimics both the GLP-1 hormone and a hormone called amylin. The FDA granted approval to Novo Nordisk's popular diabetes medicine, Ozempic, to reduce the risk of worsening kidney disease and cardiovascular death in adults with type II diabetes and chronic kidney disease. The approval is based on data from the pivotal FLOW phase IIIb kidney outcomes study. In 2020. Ozempic was approved by the FDA to reduce the risk of major cardiovascular events in patients with type II diabetes and known heart disease. Merck's phase III LEAP-015 study, evaluating blockbuster PD-L1 inhibitor, Keytruda and partner Eisai's Lenvima plus chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastroesophageal adenocarcinoma, met one of the dual primary endpoints while missing the other. At the interim analysis, treatment with the Keytruda plus Lenvima-based regimen led to a statistically significant improvement in progression-free survival – one of the study's dual primary endpoints –versus standard-of-care chemotherapy. However, in the final analysis, the study failed to show a statistically significant increase in overall survival, the study's second primary endpoint. The Keytruda plus Lenvima combination is currently approved in the United States, Europe, Japan and other countries for treating certain types of advanced endometrial carcinoma and advanced renal cell carcinoma ('RCC'). Merck also announced the decision to stop the phase III HYPERION study on its new pulmonary arterial hypertension (PAH) drug, Winrevair, due to strong positive interim efficacy data from other Winrevair studies, including the STELLAR and ZENITH studies. The program's external steering committee concluded that since the other Winrevair studies have already demonstrated robust efficacy data across a broad spectrum of patients, continuing the placebo-controlled HYPERION study would be unethical, and it was therefore stopped early. Winrevair is approved in the United States and several other countries to treat PAH, WHO Group 1 based on data from the phase III STELLAR study. The FDA granted priority review to a supplemental new drug application (sNDA) seeking approval for Merck's oral HIF-2α inhibitor, Welireg for the treatment of patients with advanced pheochromocytoma and paraganglioma. Currently, there are no approved therapies for treating these rare adrenal tumors. The FDA's decision on the sNDA is expected on May 26, 2025. The NDA was based on data from the phase II LITESPARK-015 study. Welireg is currently approved in the United States for patients with advanced RCC and some von Hippel-Lindau disease-associated tumors. The FDA granted approval to AstraZeneca/Daiichi's Enhertu for treating unresectable or metastatic HER2-low or HER2-ultralow metastatic breast cancer in adult patients whose disease has progressed after one or more endocrine therapies. The FDA's approval is based on data from the phase III DESTINY-Breast06 study. The FDA approval will expand the currently approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. Following this approval, AstraZeneca will be entitled to make a milestone payment of $175 million to Daiichi. Enhertu is presently also approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and previously treated HER2-positive solid tumors. The NYSE ARCA Pharmaceutical Index rose 4.3% in the past five trading sessions. Large Cap Pharmaceuticals Industry 5YR % Return Here's how the eight major stocks performed in the previous five trading sessions. Image Source: Zacks Investment Research All the stocks were in the green in the last five trading sessions, with Lilly rising the most (7.4%). In the past six months, all stocks were in the red. Novo Nordisk declined the most (35.7%). (See the last pharma stock roundup here: JNJ's Q4 Earnings, FDA Nod to AZN, Daiichi Drug) Watch this space for PFE, MRK, LLY and AZN's fourth-quarter results and regular pipeline and regulatory updates next week. Merck and AstraZeneca have a Zacks Rank #3 (Hold) each, while Sanofi, Roche and Novo Nordisk have a Zacks Rank #4 (Sell). 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 Sanofi (SNY) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
Euronews
27-01-2025
- Business
- Euronews
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. A next-generation weight-loss drug 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. Growing competition in oral treatment 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.
