Latest news with #REDEFINE
Yahoo
3 days ago
- Business
- Yahoo
Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies
Deep Apple Therapeutics, Inc. announced on Wednesday a research collaboration and exclusive worldwide license agreement with Novo Nordisk A/S (NYSE:NVO) to discover, develop, and commercialize oral small molecule therapeutics directed at a novel non-incretin GPCR target for cardiometabolic diseases, including obesity. Under the terms of the agreement, Deep Apple will discover and optimize compounds using its proprietary drug discovery platform, which combines machine-learning-powered virtual screening with structural biology enabled by cryo-electron microscopy (cryo-EM) to dramatically improve speed, quality, and novelty in lead generation and optimization. Novo Nordisk will receive exclusive global rights to develop, manufacture, and commercialize the resulting compounds and products in all companies will collaborate on the research plan, with program handoff to Novo Nordisk occurring immediately before the start of IND-enabling studies. Deep Apple is eligible to receive an upfront payment, research costs, and milestone payments from Novo Nordisk. Deep Apple will be eligible to receive up to $812 million in payments and potential royalties on sales of any products that emerge from the collaboration. Recently, the Danish pharma giant initiated a Phase 3 trial to evaluate the efficacy and safety of cagrilintide sc combined with semaglutide sc (CagriSema sc) once weekly for weight management and long-term weight maintenance in obese participants. The two-part study in around 600 participants will last about 3 years and 3 months. In March, Novo Nordisk announced headline results from the REDEFINE 2 phase 3 trial in the global REDEFINE program. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema compared to placebo. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose. When evaluating treatment effects, if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Last week, Regeneron Pharmaceuticals, Inc.(NASDAQ:REGN) released interim results from the ongoing Phase 2 COURAGE trial evaluating Regeneron's trevogrumab (anti-GDF8/anti-myostatin) with semaglutide (GLP-1 receptor agonist) with or without garetosmab (anti-activin A) for obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to the loss of lean mass. Price Action: NVO stock is up 0.04% at $79.36 at the last check Wednesday. Read Next:Photo by JHVEPhoto via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? NOVO NORDISK (NVO): Free Stock Analysis Report This article Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
4 days ago
- Health
- Yahoo
ADA 2025: Novo Nordisk highlights strong portfolio data with new semaglutide and CagriSema results, redefining possibilities in obesity and diabetes care
Novo Nordisk to present data from STEP UP trial on a higher dose of Wegovy® (semaglutide 7.2 mg) for those in need of greater weight loss Data will expand semaglutide evidence in both a clinical and real-world setting, including cardiometabolic and kidney health benefits for those with obesity and diabetes Novo Nordisk continues to pioneer obesity innovation, including presentation of full Phase 3 REDEFINE 1 and 2 trial results, providing insights into the transformational potential of CagriSema Bagsværd, Denmark, 10 June – Novo Nordisk today announced that new data from its industry-leading portfolio in metabolic and cardiovascular health will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 – 23 June 2025. A total of 29 abstracts will be presented, including trials investigating the weight loss efficacy of higher dose Wegovy® (semaglutide 7.2 mg) in people with obesity (STEP UP) and those with obesity and type 2 diabetes (STEP UP T2D) as a new option for those in need of greater weight loss. New data will offer additional evidence of the broader cardiovascular and kidney health benefits of semaglutide for people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from further real-world studies of semaglutide 2.4 mg. The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the transformational potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's commitment to obesity innovation and individualised healthcare solutions. On 22 June, Novo Nordisk will also host an R&D investor event on their metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. 'Aiming to address individual needs and preferences for better health, we look forward to providing a higher dose of Wegovy® (semaglutide 7.2 mg) for people with obesity in need of more significant weight loss, alongside the broader health benefits seen with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'Semaglutide has shown comprehensive and disease-modifying effects across the metabolic and cardiovascular health spectrum, and the data presented at ADA 2025 for Wegovy®, Rybelsus®, and Ozempic® will add to this evidence base as we aspire to a future where semaglutide is a foundational therapy that can provide people with comprehensive protection, early enough to make a difference.' 'We recognise the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalised treatment approach,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'As we look to further build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease.' Novo Nordisk data overview at ADA 2025: ADA Scientific Sessions: Diabetes and peripheral artery disease—evolving role of GLP-1 RA and new insights from the STRIDE trial - Saturday 21 June; 13:30–15:00 CDT Efficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 clinical trials - Sunday 22 June; 8:00–9:30 CDT SOUL trial—effects of oral semaglutide on cardiovascular (and other) outcomes in people with type 2 diabetes at high CV risk - Sunday 22 June; 16:30–18:00 CDT Novo Nordisk poster and oral presentations: Ozempic® (once-weekly semaglutide 1.0 mg) Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD: data from the FLOW Trial. Poster presentation (1971-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: a long-term cost effectiveness analysis based on FLOW. Poster presentation (782-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures in US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) who received once-weekly (OW) semaglutide. Poster presentation (838-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures among US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) receiving once-weekly semaglutide (sema OW) vs. oral antidiabetic medications (ADMs). Poster presentation (2005-LB poster) - Sunday 22 June; 12:30–13:30 CDT Effect of type 2 diabetes characteristics on semaglutide treatment in people with type 2 diabetes and peripheral artery disease: a post-hoc analysis of the STRIDE Trial. Oral presentation (291-OR) - Monday 23 June; 13:30–13:45 CDT Rybelsus® (once-daily oral semaglutide) Real-world impact of oral semaglutide (sema) alone and vs DPP-4is on weight, BMI and HbA1c outcomes in type 2 diabetes (T2D): an observational study (PAUSE). Poster presentation (732-P) - Sunday 22 June; 12:30–13:30 CDT Oral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (292-OR) - Monday 23 June; 13:45–14:00 CDT Wegovy® (once-weekly semaglutide 2.4 mg) Demographic and clinical characteristics associated with real-world persistence on semaglutide for weight management in the USA. Poster presentation (786-P) - Sunday 22 June; 12:30–13:30 CDT Two-year real-world effectiveness of semaglutide in patients with obesity or overweight. Poster presentation (1733-P) - Monday 23 June; 12:30–13:30 CDT Reduction of the 10-Year ASCVD risk in patients with overweight or obesity treated with semaglutide 2.4 mg in routine clinical care: a real-world study. Poster presentation (1734-P) - Monday 23 June; 12:30–13:30 CDT Once-weekly semaglutide 7.2 mg Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB ePoster) - Saturday 21 June; 13:30–15:00 CDT Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB poster) - Sunday 22 June; 12:30–13:30 CDT Efficacy and safety of semaglutide 7.2 mg in obesity and type 2 diabetes: STEP UP T2D trial. Poster presentation (1978-LB poster) - Sunday 22 June; 12:30–13:30 CDT CagriSema Effect of combined therapy with once-weekly subcutaneous cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) on energy intake, gastric emptying, and appetite in adults with overweight or obesity. Poster presentation (1969-LB poster) - Sunday 22 June; 12:30–13:30 CDT Diabetes, cagrisema-induced weight loss in diet-induced obese rats relies on preserved mitochondrial leak respiration in skeletal muscle. Poster presentation (1693-P) - Monday 23 June; 12:30–13:30 CDT Amycretin/amylin The amylin receptor selective agonist NN1213 reduces food intake and body weight in rats without decreasing calcium plasma levels. Oral presentation (86-OR) - Friday 20 June; 14:45–15:00 CDT Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Poster presentation (2002-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly insulin icodec Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by diabetes duration: ONWARDS 1–5. Poster presentation (816-P) - Saturday 21 June; 12:30– 13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline A1C: ONWARDS 1–5. Poster presentation (822-P) - Saturday 21 June; 12:30–13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline BMI: ONWARDS 1–5. Poster presentation (819-P) - Saturday 21 June; 12:30–13:30 CDT Once-weekly IcoSema CGM-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3. Poster presentation (815-P) - Saturday 21 June; 12:30–13:30 CDT A1C and hypoglycemia outcomes with once-weekly IcoSema vs comparators in T2D by kidney function. Poster presentation (804-P) - Saturday 21 June; 12:30–13:30 CDT CGM-based outcomes in adults with T2D receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3. Poster presentation (830-P) - Saturday 21 June; 12:30–13:30 CDT Comparison of characteristics among individuals with established vs newly diagnosed type 2 diabetes during ischemic stroke hospitalization – a retrospective cohort study. Poster presentation (1373-P) - Saturday 21 June; 12:30–13:30 CDT Digital Health Effect of telemonitoring using connected devices on insulin injection adherence in people living with T2D. Oral presentation (315-OR) - Monday 23 June; 13:30–13:45 CDT Tracking treatment outcomes using the semaglutide patient support solution app. Poster presentation (1098-P) - Sunday 22 June; 12:30–13:30 CDT General diabetes Prevalence and factors for treatment failure with sodium-glucose co-transporter 2 inhibitor (SGLT2i) in US adults with type 2 diabetes (T2D). Poster presentation (909-P) - Sunday 22 June; 12:30–13:30 CDT Macrovascular and microvascular complications in Medicare patients with type 2 diabetes and atherosclerotic cardiovascular disease from 2006-2021: incidence stratified by sex, age, and race/ethnicity. Poster presentation (1870-LB poster) - Sunday 22 June; 12:30–13:30 CDT Elevated body mass index at type 2 diabetes diagnosis is associated with increased risk of cardiovascular disease and kidney outcomes. Poster presentation (427-P) - Monday 23 June; 12:30–13:30 CDT General obesity Health utilities of people with obesity in Taiwan: a nationwide representative analysis. Publication Only (63-PUB) About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018.1 Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness, thereby helping people eat less and reduce their calorie intake. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration. About once-weekly basal insulin icodec Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. About once-weekly IcoSema Once-weekly IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin icodec/1mg semaglutide). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ 1 Novo Nordisk data on file. Attachment PR250610-ADA-Curtain-RaiserSign in to access your portfolio
Yahoo
4 days ago
- Health
- Yahoo
ADA 2025: Novo Nordisk highlights strong portfolio data with new semaglutide and CagriSema results, redefining possibilities in obesity and diabetes care
Novo Nordisk to present data from STEP UP trial on a higher dose of Wegovy® (semaglutide 7.2 mg) for those in need of greater weight loss Data will expand semaglutide evidence in both a clinical and real-world setting, including cardiometabolic and kidney health benefits for those with obesity and diabetes Novo Nordisk continues to pioneer obesity innovation, including presentation of full Phase 3 REDEFINE 1 and 2 trial results, providing insights into the transformational potential of CagriSema Bagsværd, Denmark, 10 June – Novo Nordisk today announced that new data from its industry-leading portfolio in metabolic and cardiovascular health will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 – 23 June 2025. A total of 29 abstracts will be presented, including trials investigating the weight loss efficacy of higher dose Wegovy® (semaglutide 7.2 mg) in people with obesity (STEP UP) and those with obesity and type 2 diabetes (STEP UP T2D) as a new option for those in need of greater weight loss. New data will offer additional evidence of the broader cardiovascular and kidney health benefits of semaglutide for people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from further real-world studies of semaglutide 2.4 mg. The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the transformational potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's commitment to obesity innovation and individualised healthcare solutions. On 22 June, Novo Nordisk will also host an R&D investor event on their metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. 'Aiming to address individual needs and preferences for better health, we look forward to providing a higher dose of Wegovy® (semaglutide 7.2 mg) for people with obesity in need of more significant weight loss, alongside the broader health benefits seen with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'Semaglutide has shown comprehensive and disease-modifying effects across the metabolic and cardiovascular health spectrum, and the data presented at ADA 2025 for Wegovy®, Rybelsus®, and Ozempic® will add to this evidence base as we aspire to a future where semaglutide is a foundational therapy that can provide people with comprehensive protection, early enough to make a difference.' 'We recognise the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalised treatment approach,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'As we look to further build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease.' Novo Nordisk data overview at ADA 2025: ADA Scientific Sessions: Diabetes and peripheral artery disease—evolving role of GLP-1 RA and new insights from the STRIDE trial - Saturday 21 June; 13:30–15:00 CDT Efficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 clinical trials - Sunday 22 June; 8:00–9:30 CDT SOUL trial—effects of oral semaglutide on cardiovascular (and other) outcomes in people with type 2 diabetes at high CV risk - Sunday 22 June; 16:30–18:00 CDT Novo Nordisk poster and oral presentations: Ozempic® (once-weekly semaglutide 1.0 mg) Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD: data from the FLOW Trial. Poster presentation (1971-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: a long-term cost effectiveness analysis based on FLOW. Poster presentation (782-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures in US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) who received once-weekly (OW) semaglutide. Poster presentation (838-P) - Sunday 22 June; 12:30–13:30 CDT Changes in clinical measures among US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) receiving once-weekly semaglutide (sema OW) vs. oral antidiabetic medications (ADMs). Poster presentation (2005-LB poster) - Sunday 22 June; 12:30–13:30 CDT Effect of type 2 diabetes characteristics on semaglutide treatment in people with type 2 diabetes and peripheral artery disease: a post-hoc analysis of the STRIDE Trial. Oral presentation (291-OR) - Monday 23 June; 13:30–13:45 CDT Rybelsus® (once-daily oral semaglutide) Real-world impact of oral semaglutide (sema) alone and vs DPP-4is on weight, BMI and HbA1c outcomes in type 2 diabetes (T2D): an observational study (PAUSE). Poster presentation (732-P) - Sunday 22 June; 12:30–13:30 CDT Oral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (292-OR) - Monday 23 June; 13:45–14:00 CDT Wegovy® (once-weekly semaglutide 2.4 mg) Demographic and clinical characteristics associated with real-world persistence on semaglutide for weight management in the USA. Poster presentation (786-P) - Sunday 22 June; 12:30–13:30 CDT Two-year real-world effectiveness of semaglutide in patients with obesity or overweight. Poster presentation (1733-P) - Monday 23 June; 12:30–13:30 CDT Reduction of the 10-Year ASCVD risk in patients with overweight or obesity treated with semaglutide 2.4 mg in routine clinical care: a real-world study. Poster presentation (1734-P) - Monday 23 June; 12:30–13:30 CDT Once-weekly semaglutide 7.2 mg Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB ePoster) - Saturday 21 June; 13:30–15:00 CDT Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB poster) - Sunday 22 June; 12:30–13:30 CDT Efficacy and safety of semaglutide 7.2 mg in obesity and type 2 diabetes: STEP UP T2D trial. Poster presentation (1978-LB poster) - Sunday 22 June; 12:30–13:30 CDT CagriSema Effect of combined therapy with once-weekly subcutaneous cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) on energy intake, gastric emptying, and appetite in adults with overweight or obesity. Poster presentation (1969-LB poster) - Sunday 22 June; 12:30–13:30 CDT Diabetes, cagrisema-induced weight loss in diet-induced obese rats relies on preserved mitochondrial leak respiration in skeletal muscle. Poster presentation (1693-P) - Monday 23 June; 12:30–13:30 CDT Amycretin/amylin The amylin receptor selective agonist NN1213 reduces food intake and body weight in rats without decreasing calcium plasma levels. Oral presentation (86-OR) - Friday 20 June; 14:45–15:00 CDT Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Poster presentation (2002-LB poster) - Sunday 22 June; 12:30–13:30 CDT Once-weekly insulin icodec Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by diabetes duration: ONWARDS 1–5. Poster presentation (816-P) - Saturday 21 June; 12:30– 13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline A1C: ONWARDS 1–5. Poster presentation (822-P) - Saturday 21 June; 12:30–13:30 CDT Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline BMI: ONWARDS 1–5. Poster presentation (819-P) - Saturday 21 June; 12:30–13:30 CDT Once-weekly IcoSema CGM-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3. Poster presentation (815-P) - Saturday 21 June; 12:30–13:30 CDT A1C and hypoglycemia outcomes with once-weekly IcoSema vs comparators in T2D by kidney function. Poster presentation (804-P) - Saturday 21 June; 12:30–13:30 CDT CGM-based outcomes in adults with T2D receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3. Poster presentation (830-P) - Saturday 21 June; 12:30–13:30 CDT Comparison of characteristics among individuals with established vs newly diagnosed type 2 diabetes during ischemic stroke hospitalization – a retrospective cohort study. Poster presentation (1373-P) - Saturday 21 June; 12:30–13:30 CDT Digital Health Effect of telemonitoring using connected devices on insulin injection adherence in people living with T2D. Oral presentation (315-OR) - Monday 23 June; 13:30–13:45 CDT Tracking treatment outcomes using the semaglutide patient support solution app. Poster presentation (1098-P) - Sunday 22 June; 12:30–13:30 CDT General diabetes Prevalence and factors for treatment failure with sodium-glucose co-transporter 2 inhibitor (SGLT2i) in US adults with type 2 diabetes (T2D). Poster presentation (909-P) - Sunday 22 June; 12:30–13:30 CDT Macrovascular and microvascular complications in Medicare patients with type 2 diabetes and atherosclerotic cardiovascular disease from 2006-2021: incidence stratified by sex, age, and race/ethnicity. Poster presentation (1870-LB poster) - Sunday 22 June; 12:30–13:30 CDT Elevated body mass index at type 2 diabetes diagnosis is associated with increased risk of cardiovascular disease and kidney outcomes. Poster presentation (427-P) - Monday 23 June; 12:30–13:30 CDT General obesity Health utilities of people with obesity in Taiwan: a nationwide representative analysis. Publication Only (63-PUB) About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018.1 Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness, thereby helping people eat less and reduce their calorie intake. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration. About once-weekly basal insulin icodec Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. About once-weekly IcoSema Once-weekly IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin icodec/1mg semaglutide). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ 1 Novo Nordisk data on file. Attachment PR250610-ADA-Curtain-RaiserSign in to access your portfolio
Yahoo
10-03-2025
- Health
- Yahoo
Novo Nordisk A/S: CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial
Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo. The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose. When evaluating the effects of treatment, if all people adhered to treatment1, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo. When applying the treatment policy estimand2, people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class. 'The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes', said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.' Novo Nordisk expects to file for the first regulatory approval of CagriSema in the first quarter of 2026. The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025. About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake. About the REDEFINE clinical trial programmeREDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes: REDEFINE 1 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight. REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes. REDEFINE 4 – an 84-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289ambre@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649idmg@ Max Ung +45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568 fptr@ Company announcement No 11 / 20251 Based on the trial product estimand according to the trial protocol, regardless of dose strength2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence Attachment CA250310-CagriSema-REDEFINE2Sign in to access your portfolio
Yahoo
06-02-2025
- Business
- Yahoo
Novo Nordisk AS (NVO) Q4 2024 Earnings Call Highlights: Robust Growth in Sales and Profit Amid ...
Sales Growth: 26% increase in 2024. Operating Profit Growth: 26% increase in 2024. North American Operations Sales Growth: 30% increase. International Operations Sales Growth: 19% increase. GLP-1 Sales in Diabetes: 22% increase. Insulin Sales Growth: 17% increase. Obesity Care Sales Growth: 57% increase. Rare Disease Sales Growth: 9% increase. Gross Margin: Increased to 84.7% from 84.6% in 2023. Research and Development Costs: Increased by 48%. Net Profit Increase: 21% increase. Diluted Earnings Per Share: Increased by 22% to DKK22.63. Cash Flow from Operating Activities: DKK121 billion, an increase of DKK12 billion from 2023. Free Cash Flow: Minus DKK14.7 billion. Dividend Increase: 21% increase to DKK11.40 per share. Share Buyback Program: DKK20 billion concluded. Warning! GuruFocus has detected 1 Warning Sign with NVO. Release Date: February 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novo Nordisk AS (NYSE:NVO) reported a strong 26% sales growth and 26% operating profit growth for 2024. The company expanded its patient reach, now serving over 45 million patients with diabetes and obesity treatments. Obesity care sales increased by 57%, driven by significant growth in both North America and international operations. Novo Nordisk AS (NYSE:NVO) maintained its leadership in the GLP-1 market, serving nearly two-thirds of all patients on GLP-1 treatments. The company completed the acquisition of Catalent sites, enhancing its global fill and finish footprint, which will support future market supply expansion. Total carbon emissions rose by 23% due to increased production volumes and capital expenditure investments. Research and development costs increased by 48%, reflecting higher clinical trial activity and impairment losses related to intangible assets. The net financial items showed a net loss of DKK1.1 billion, primarily due to losses on non-hedged currencies. The effective tax rate increased to 20.6% in 2024, compared to 20.1% in 2023. Free cash flow was negative at minus DKK14.7 billion, impacted by significant capital expenditures and the Catalent site acquisition. Q: Could you give us more details on what's holding back Wegovy prescriptions in the US and how should we anticipate growth from here? A: The US market for anti-obesity medicines grew by 160% last year, and Wegovy prescriptions doubled from 100,000 to over 200,000. Early in the year, prescription trends are affected by changes in benefit plans and patient co-pays. We are focusing on driving new prescriptions and have increased the supply of starter doses to meet demand. - David Moore, Executive Vice President, Corporate Development Q: How do you think the profile of CagriSema will stack up versus competitors, and what are your thoughts on REDEFINE 4? A: In REDEFINE 4, CagriSema will be compared to semaglutide. We expect to establish non-inferiority and potentially superiority based on REDEFINE 1 results, but it's too early to speculate on the outcomes. - Martin Lange, Executive Vice President, Development Q: Can you explain the discrepancy in weight loss profiles in REDEFINE 1 and what this means for REDEFINE 2? A: We observed two distinct groups in REDEFINE 1: those who titrated to the full dose and early responders who lost weight faster. The latter group showed potential for more weight loss with longer treatment. This individual response pattern will inform future trials, including REDEFINE 11. - Martin Lange, Executive Vice President, Development Q: How do you see the positioning of amycretin versus CagriSema, and what is the timing for the Phase 3 program for amycretin? A: With the size of the obesity market, having a broad portfolio is key. Amycretin offers scalability and flexibility with both injectable and oral formulations. We are planning further clinical development based on promising Phase 1/2 data. - Camilla Sylvest, Executive Vice President, Commercial Strategy and Corporate Affairs Q: How do you plan to manage the situation with the Inflation Reduction Act (IRA) for semaglutide in the US? A: Semaglutide products are selected for the second round of CMS negotiations. The process will conclude in November, with the maximum fair price effective from January 2027. We oppose government price setting and are monitoring the situation closely. - David Moore, Executive Vice President, Corporate Development For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
