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Globe and Mail
3 days ago
- Business
- Globe and Mail
Noonan Syndrome Market Growth to Accelerate in Forecast Period (2023-2032), DelveInsight Analyzes
DelveInsight's 'Noonan Syndrome Market Insights, Epidemiology, and Market Forecast-2032″ report offers an in-depth understanding of the Noonan Syndrome, historical and forecasted epidemiology as well as the Noonan Syndrome market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. The latest healthcare forecast report provides an in-depth analysis of Noonan Syndrome, offering comprehensive insights into the Noonan Syndrome revenue trends, prevalence, and treatment landscape. The report delves into key Noonan Syndrome statistics, highlighting the current and projected market size, while examining the efficacy and development of emerging Noonan Syndrome therapies. Additionally, we cover the landscape of Noonan Syndrome clinical trials, providing an overview of ongoing and upcoming studies that are poised to shape the future of Noonan Syndrome treatment. This report is an essential resource for understanding the market dynamics and the evolving therapeutic options within the Noonan Syndrome space. Some of the key facts of the Noonan Syndrome Market Report: The Noonan Syndrome market size is anticipated to grow with a significant CAGR during the study period (2019-2032) In May 2025, Novo Nordisk's once-weekly Sogroya (somapacitan) demonstrated non-inferiority compared to the once-daily growth hormone Norditropin (somatropin) in a Phase III trial focused on pediatric growth disorders. The Danish company reported that Sogroya enhanced the annual growth rate in pre-pubertal children born small for gestational age (SGA), those with Noonan syndrome (NS), or those with idiopathic short stature (ISS), as shown in the Phase III REAL8 basket study (NCT05330325). Key Noonan Syndrome Companies: Sanofi, Novo Nordisk A/S, BioMarin Pharmaceutical, and others Key Noonan Syndrome Therapies: MAXOMAT ®, somatropin, Vosoritide Injection, and others The Noonan Syndrome market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Noonan Syndrome pipeline products will significantly revolutionize the Noonan Syndrome market dynamics. The prevalence of Noonan Syndrome Occurs in approximately 1 in 1,000 to 2,500 live births worldwide Noonan Syndrome is One of the more common genetic syndromes affecting multiple systems Noonan Syndrome Affects males and females equally, with no significant gender bias Caused by mutations in genes involved in the RAS/MAPK pathway, including PTPN11, SOS1, RAF1, and others About 50% of cases are due to mutations in the PTPN11 gene Noonan Syndrome Overview Noonan Syndrome is a genetic disorder that affects multiple parts of the body. It is characterized by distinctive facial features, short stature, heart defects (such as pulmonary valve stenosis), developmental delays, and other health issues. The condition is caused by mutations in genes involved in the RAS/MAPK signaling pathway, which plays a key role in cell growth and development. Noonan Syndrome occurs in both males and females and varies widely in severity. Early diagnosis and management can help address the associated complications and improve quality of life. Get a Free sample for the Noonan Syndrome Market Forecast, Size & Share Analysis Report: Noonan Syndrome Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Noonan Syndrome Epidemiology Segmentation: The Noonan Syndrome market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Noonan Syndrome Prevalent Cases of Noonan Syndrome by severity Gender-specific Prevalence of Noonan Syndrome Diagnosed Cases of Episodic and Chronic Noonan Syndrome Download the report to understand which factors are driving Noonan Syndrome epidemiology trends @ Noonan Syndrome Epidemiology Forecast Noonan Syndrome Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Noonan Syndrome market or expected to get launched during the study period. The analysis covers Noonan Syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Noonan Syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Noonan Syndrome Therapies and Key Companies Discover more about therapies set to grab major Noonan Syndrome market share @ Noonan Syndrome Treatment Landscape Noonan Syndrome Market Drivers Rising Diagnosis Rates Advancements in Genetic Research Pharmaceutical Collaborations Government Initiatives Noonan Syndrome Market Barriers Lack of Approved Therapies High Treatment Costs Limited Awareness Genetic Heterogeneity Scope of the Noonan Syndrome Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Noonan Syndrome Companies: Sanofi, Novo Nordisk A/S, BioMarin Pharmaceutical, and others Key Noonan Syndrome Therapies: MAXOMAT ®, somatropin, Vosoritide Injection, and others Noonan Syndrome Therapeutic Assessment: Noonan Syndrome current marketed and Noonan Syndrome emerging therapies Noonan Syndrome Market Dynamics: Noonan Syndrome market drivers and Noonan Syndrome market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Noonan Syndrome Unmet Needs, KOL's views, Analyst's views, Noonan Syndrome Market Access and Reimbursement Table of Contents 1. Noonan Syndrome Market Report Introduction 2. Executive Summary for Noonan Syndrome 3. SWOT analysis of Noonan Syndrome 4. Noonan Syndrome Patient Share (%) Overview at a Glance 5. Noonan Syndrome Market Overview at a Glance 6. Noonan Syndrome Disease Background and Overview 7. Noonan Syndrome Epidemiology and Patient Population 8. Country-Specific Patient Population of Noonan Syndrome 9. Noonan Syndrome Current Treatment and Medical Practices 10. Noonan Syndrome Unmet Needs 11. Noonan Syndrome Emerging Therapies 12. Noonan Syndrome Market Outlook 13. Country-Wise Noonan Syndrome Market Analysis (2019–2032) 14. Noonan Syndrome Market Access and Reimbursement of Therapies 15. Noonan Syndrome Market Drivers 16. Noonan Syndrome Market Barriers 17. Noonan Syndrome Appendix 18. Noonan Syndrome Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
12-05-2025
- Business
- Yahoo
Novo Nordisk's Sogroya Supports Effective Weekly Alternative To Daily Hormone Therapy Across Three Growth Disorders
Novo Nordisk A/S (NYSE:NVO) on Monday presented data from the phase 3 REAL8 basket study investigating once-weekly Sogroya (somapacitan) in four different but related growth disorder indications, including small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS), and idiopathic short stature (ISS) under one trial protocol. In REAL8, pre-pubertal children with NS, TS, or ISS were randomized to receive either once-weekly Sogroya (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day. Children born SGA were randomized to receive either somapacitan 0.24 mg/kg/week, a low dose of somatropin 0.035 mg/kg/day, or a high dose of somatropin 0.067 mg/kg/ trial showed that once-weekly Sogroya was non-inferior to the once-daily growth hormone Norditropin (somatropin) in improving yearly growth rate (as measured by height velocity or HV at Week 52). In addition, once-weekly Sogroya was superior to daily growth hormone in children with NS and to lower doses of daily growth hormone in children born SGA. REAL8 data showed that Sogroya was well-tolerated, with no safety or tolerability issues identified compared to once-daily growth hormone. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: In children born SGA, Sogroya demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year) and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year). Sogroya demonstrated superior estimated mean HV in children with NS compared with somatropin (10.4 vs 9.2 cm/year). Sogroya demonstrated non-inferior estimated mean HV in children with ISS compared with daily somatropin (10.5 vs 10.5 cm/year). In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS, and ISS) were submitted for regulatory review in both the EU and the U.S. Price Action: NVO stock is down 3.00% to $63.80 during the premarket session at the last check on Monday. Image 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's Sogroya Supports Effective Weekly Alternative To Daily Hormone Therapy Across Three Growth Disorders originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
Yahoo
12-05-2025
- Health
- Yahoo
Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE
The REAL8 trial showed that after 52 weeks, once-weekly Sogroya® (somapacitan) had similar clinical outcomes and safety profile to once-daily Norditropin® (somatropin) in children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature3. Superiority was achieved for once-weekly somapacitan versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. These conditions are often associated with significant health challenges and a high treatment burden from daily injections4, which can lead to a lack of adherence and put successful treatment outcomes at risk. Novo Nordisk is committed to bringing our expertise and scientific innovation to help improve the lives of children with conditions that impact their growth. Bagsværd, Denmark, 12 May 2025 – Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature (ISS)3. In addition, superiority was achieved for once-weekly Sogroya® versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. REAL8 data showed that Sogroya® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone1-3. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya® was similar to those treated with daily growth hormone1-3. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark1-3. 'Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,' said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. 'The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.' The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: In children born SGA, Sogroya® demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year), and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year)1. In children with NS, Sogroya® demonstrated superior estimated mean HV compared with somatropin (10.4 vs 9.2 cm/year)2. In children with ISS, Sogroya® demonstrated non-inferior estimated mean HV compared with daily somatropin (10.5 vs 10.5 cm/year)3. Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life5. One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients4. 'Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,' said Martin Lange, executive vice president for Development at Novo Nordisk. 'We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.' In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase6. REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol6. This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources7, potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day6. About REAL9The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years8. About once-weekly Sogroya® Once-weekly Sogroya® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone9,10. Using albumin-binding prolongation technology, Sogroya® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk's diabetes treatment. It allows for the growth hormone to work longer11. 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@ David Heiberg Landsted +45 3077 6915 dhel@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649 idmg@ Frederik Taylor Pitter +1 609 613 0568fptr@ References1. Linglart A, Bottcher V, Rassmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4131.2. Jorge A, Albanese A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial. Poster presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4118.3. Abuzzahab J, Dauber A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4048.4. Loftus J, Miller BS, Parzynski CS, et al. Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency. Endocr Pract. 2022;28:565-571.5. Brod M, Hojbjerre L, Alolga SL, et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10:653-666.6. NCT05330325. A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8). Available at: Last accessed: May 2025.7. Definitive Healthcare. Basket trial. Available at: Last accessed: April 2025.8. NCT05723835. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (REAL 9). Available at: Last accessed: May 2025.9. Sogroya® (somapacitan): SmPC. 2025 [online] Available at: Last accessed: May 2025.10. Sogroya® (somapacitan-beco injection) US PI. 2025 [online] Available at: Last accessed: May 2025.11. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419. Attachment PR250512-ESPE-ESE-2025-REAL8
Yahoo
12-05-2025
- Health
- Yahoo
Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE
The REAL8 trial showed that after 52 weeks, once-weekly Sogroya® (somapacitan) had similar clinical outcomes and safety profile to once-daily Norditropin® (somatropin) in children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature3. Superiority was achieved for once-weekly somapacitan versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. These conditions are often associated with significant health challenges and a high treatment burden from daily injections4, which can lead to a lack of adherence and put successful treatment outcomes at risk. Novo Nordisk is committed to bringing our expertise and scientific innovation to help improve the lives of children with conditions that impact their growth. Bagsværd, Denmark, 12 May 2025 – Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA)1, or with Noonan syndrome (NS)2, or with idiopathic short stature (ISS)3. In addition, superiority was achieved for once-weekly Sogroya® versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA1. REAL8 data showed that Sogroya® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone1-3. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya® was similar to those treated with daily growth hormone1-3. Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark1-3. 'Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,' said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. 'The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.' The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: In children born SGA, Sogroya® demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year), and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year)1. In children with NS, Sogroya® demonstrated superior estimated mean HV compared with somatropin (10.4 vs 9.2 cm/year)2. In children with ISS, Sogroya® demonstrated non-inferior estimated mean HV compared with daily somatropin (10.5 vs 10.5 cm/year)3. Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life5. One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients4. 'Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,' said Martin Lange, executive vice president for Development at Novo Nordisk. 'We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.' In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase6. REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol6. This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources7, potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day6. About REAL9The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years8. About once-weekly Sogroya® Once-weekly Sogroya® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone9,10. Using albumin-binding prolongation technology, Sogroya® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk's diabetes treatment. It allows for the growth hormone to work longer11. 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@ David Heiberg Landsted +45 3077 6915 dhel@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649 idmg@ Frederik Taylor Pitter +1 609 613 0568fptr@ References1. Linglart A, Bottcher V, Rassmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4131.2. Jorge A, Albanese A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial. Poster presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4118.3. Abuzzahab J, Dauber A, Rasmussen MH, et al. Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4048.4. Loftus J, Miller BS, Parzynski CS, et al. Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency. Endocr Pract. 2022;28:565-571.5. Brod M, Hojbjerre L, Alolga SL, et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient. 2017;10:653-666.6. NCT05330325. A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8). Available at: Last accessed: May 2025.7. Definitive Healthcare. Basket trial. Available at: Last accessed: April 2025.8. NCT05723835. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (REAL 9). Available at: Last accessed: May 2025.9. Sogroya® (somapacitan): SmPC. 2025 [online] Available at: Last accessed: May 2025.10. Sogroya® (somapacitan-beco injection) US PI. 2025 [online] Available at: Last accessed: May 2025.11. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419. Attachment PR250512-ESPE-ESE-2025-REAL8Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
