Latest news with #Skytrofa
Globe and Mail
11-04-2025
- Health
- Globe and Mail
Hypopituitarism Market on Track for Major Expansion by 2032, According to DelveInsight
The Key Hypopituitarism Companies in the market include - Ascendis Pharma, Lumos Pharma, Novartis, Pfizer, Eli Lilly and Company, Merck & Co., AbbVie, Novo Nordisk, Sanofi, AstraZeneca, Teva Pharmaceutical Industries, Ferring Pharmaceuticals, and others. DelveInsight's 'Hypopituitarism Market Insights, Epidemiology, and Market Forecast-2032″ report offers an in-depth understanding of the Hypopituitarism, historical and forecasted epidemiology as well as the Hypopituitarism market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. Some of the key facts of the Hypopituitarism Market Report: The Hypopituitarism market size is anticipated to grow with a significant CAGR during the study period (2019-2032) In December 2024, OPDIVO QVANTIG may lead to primary or secondary adrenal insufficiency, immune-related hypophysitis, immune-mediated thyroid conditions, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Depending on the severity, OPDIVO QVANTIG should be withheld [refer to section 2 Dosage and Administration in the Full Prescribing Information]. For Grade 2 or higher adrenal insufficiency, initiate appropriate symptomatic management, including hormone replacement therapy if needed. Hypophysitis may manifest with acute symptoms like headaches, sensitivity to light, or vision disturbances due to mass effect. It may also result in hypopituitarism, requiring hormone replacement as clinically appropriate. Hypopituitarism is anticipated to have a global incidence rate of 4.2 cases per 100,000 people annually, with a prevalence of 45.5 cases per 100,000, showing no distinction between genders. The FDA granted approval for the use of Skytrofa (lonapegsomatropin) in September 2021 for the treatment of pediatric patients aged one year and older who weigh at least 11.5 kg and have growth failure as a result of insufficient endogenous growth hormone secretion The study by Rogol stated that GHD in children is a relatively rare condition. In the United States, it was estimated to occur in approximately 1 in 3500 to 4000 children As per National Institute for Health and Clinical Excellence (NICE), the prevalence of growth hormone deficiency was estimated to be between 1 in 3500 and 1 in 4000 children In about half of the children with growth hormone deficiency (50%), the cause is unknown (idiopathic growth hormone deficiency) Key Hypopituitarism Companies: Ascendis Pharma, Lumos Pharma, Novartis, Pfizer, Eli Lilly and Company, Merck & Co., AbbVie, Novo Nordisk, Sanofi, AstraZeneca, Teva Pharmaceutical Industries, Ferring Pharmaceuticals, and others Key Hypopituitarism Therapies: Lonapegsomatropin, LUM-201, somapacita, and others The Hypopituitarism market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Hypopituitarism pipeline products will significantly revolutionize the Hypopituitarism market dynamics. Hypopituitarism Overview: Hypopituitarism is a rare disorder in which the pituitary gland, located at the base of the brain, fails to produce one or more of its hormones or produces them in insufficient amounts. These hormones regulate essential functions such as growth, reproduction, and metabolism. Causes of hypopituitarism can include tumors, head injuries, infections, or autoimmune conditions. Symptoms vary depending on which hormones are deficient and may include fatigue, weakness, weight loss, infertility, and growth problems. Treatment usually involves hormone replacement therapy to restore normal body functions. Hypopituitarism 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. Hypopituitarism Epidemiology Segmentation: The Hypopituitarism market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Download the report to understand which factors are driving Hypopituitarism epidemiology trends @ Hypopituitarism Epidemiology Forecast Hypopituitarism Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Hypopituitarism market or expected to get launched during the study period. The analysis covers Hypopituitarism 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 Hypopituitarism 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. Hypopituitarism Therapies and Key Companies Scope of the Hypopituitarism Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Hypopituitarism Companies: Ascendis Pharma, Lumos Pharma, Novartis, Pfizer, Eli Lilly and Company, Merck & Co., AbbVie, Novo Nordisk, Sanofi, AstraZeneca, Teva Pharmaceutical Industries, Ferring Pharmaceuticals, and others Key Hypopituitarism Therapies: Lonapegsomatropin, LUM-201, somapacitan, and others Hypopituitarism Therapeutic Assessment: Hypopituitarism current marketed and Hypopituitarism emerging therapies Hypopituitarism Market Dynamics: Hypopituitarism market drivers and Hypopituitarism market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Hypopituitarism Unmet Needs, KOL's views, Analyst's views, Hypopituitarism Market Access and Reimbursement To know more about Hypopituitarism companies working in the treatment market, visit @ Hypopituitarism Clinical Trials and Therapeutic Assessment Table of Contents 1. Hypopituitarism Market Report Introduction 2. Executive Summary 3. SWOT analysis 4. Hypopituitarism Patient Share (%) Overview at a Glance 5. Hypopituitarism Market Overview at a Glance 6. Hypopituitarism Disease Background and Overview 7. Hypopituitarism Epidemiology and Patient Population 8. Country-Specific Patient Population of Hypopituitarism 9. Hypopituitarism Current Treatment and Medical Practices 10. Hypopituitarism Unmet Needs 11. Hypopituitarism Emerging Therapies 12. Hypopituitarism Market Outlook 13. Country-Wise Hypopituitarism Market Analysis (2018–2030) 14. Market Access and Reimbursement of Therapies 15. Market drivers 16. Market barriers 17. Appendix 18. Hypopituitarism Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading 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
14-02-2025
- Business
- Yahoo
Ascendis Pharma AS (ASND) Q4 2024 Earnings Call Highlights: Strategic Growth and Market ...
Release Date: February 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Ascendis Pharma AS (NASDAQ:ASND) achieved significant milestones in 2024, setting the stage for strong growth and value creation. Skytrofa has established itself as a high-value growth hormone brand, capturing a 6.5% market share in the US. Transcon PTH, the only FDA-approved treatment for hypoparathyroidism in adults, has launched in the US and is gaining traction as a new standard of care. The company has a strong financial position with cash equivalents totaling 665 million, including a 100 million upfront payment from Novo Nordisk. Ascendis Pharma AS (NASDAQ:ASND) is expanding its TransCon technology platform beyond endocrine diseases, exploring opportunities in metabolic and cardiovascular diseases. Revenue for Skytrofa in Q4 2024 was lower than the same period in 2023, despite volume growth. The company faces challenges in establishing insurance reimbursement policies for new products like Yorvipa. There is uncertainty regarding the timeline for insurance approvals, which are estimated to take 4 to 8 weeks. Operating expenses increased by 3% in Q4 2024 compared to the previous year, driven by higher employee and commercial costs. The company has not provided specific sales guidance for Yorvipa, creating uncertainty about future financial performance. Warning! GuruFocus has detected 2 Warning Sign with ASND. Q: Can you confirm that the 908 figure is unique patients and not cumulative scripts, including refills? Also, how many of the EAP and OLE rollover patients are included in that 908 number? Lastly, are insurance approvals taking 4 to 8 weeks as expected? A: Yes, the 908 figure represents unique patient enrollments, not cumulative scripts. About 20% of the 908 are existing patients from Transcon PTH EAP or clinical trials, and 80% are new to Yorvipa. Regarding insurance approvals, 4 to 8 weeks is our estimate, but since the drug has been on the market for a short time, we need more time to confirm this timeframe. Q: Can you provide the Yorvipa patient number outside the US? A: We have not broken down the numbers outside the US yet. We are still in the early stages of commercial availability in Europe, with full commercial launches in Germany and Austria, and a non-promotional program in France. Patient numbers are increasing as expected. Q: How many of the 908 scripts have been converted to patients on actual therapy, and what proportion of these patients had previous experience with Natpara? A: We don't have all the information yet to provide a concrete answer. However, based on our market research, many of the patients are likely coming from the group we define as uncontrolled on standard therapy. We are still in the initial phase of getting patients fully reimbursed. Q: Are you considering providing sales guidance for Yorvipa for the full year sometime in the middle of the year? A: We would like to provide guidance when we are confident in the numbers. Depending on how the launch progresses and how different regions perform, we will provide revenue guidance when we feel confident. Q: How have discussions with payers gone so far for Yorvipa, and what are your assumptions for prior authorization criteria? A: Discussions with payers have been productive, focusing on the clinical value proposition of the drug. We expect prior authorization criteria to be consistent with the label, both in terms of reauthorization timelines and necessary tests. While many policies are still being established, we are encouraged by the conversations. Q: Can you provide insights on the titration process for Yorvipa in the real world? A: Endocrinologists are familiar with titrating medications, and they have found the process straightforward. We provide guidance as needed, especially when switching between different dose pens. Anecdotally, endocrinologists are comfortable with the titration process. Q: Are you planning any run-in activities for the hypochondroplasia program to help accelerate the timing of the study and enrollment? A: We are still determining the best pathway forward for hypochondroplasia, whether it will be a standalone Transcon CNP treatment or a combination with Transcon Growth Hormone. We are actively discussing with agencies and considering the unique phenotype of hypochondroplasia to find the best regulatory path forward. Q: How should we think about the capacity to meet the increasing demand for Yorvipa throughout the year? A: We have a robust supply chain in place, similar to what we use for other products like Skytrofa. We closely monitor inventory levels and are committed to ensuring there is no shortage of supply. 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
