During the corresponding time, Ascendis Pharma A recorded a revenue increase by 49.14 % year on year, sequentially revenue grew by 11.76 %. While revenue at the Ascendis Pharma A's corporate clients
Ascendis Pharma A's Comment on Sales, Marketing and Customers
The company provides treatment for adult patients with chronic hypoparathyroidism, marketing TransCon PTH under the name YORVIPATH in the European Union and European Economic Area. This product is approved for use in adults with chronic hypoparathyroidism and has received Orphan status in both the EU and Japan. Clinical development of TransCon PTH included the Phase 3 PaTHway Trial, Phase 3 PaTHway Japan Trial, and Phase 2 PaTH Forward Trial, which collectively involved 141 adult participants with hypoparathyroidism. These trials evaluated treatment efficacy, safety, and improvements in renal function among adults with hypoparathyroidism resulting from post-surgical, autoimmune, genetic, or idiopathic causes.
Ascendis Submits Marketing Authorisation Application for TransCon CNP to Treat Achondroplasia in Children COPENHAGEN, Denmark On October 8, 2025, Ascendis Pharma A/S (Nasdaq: ASND) announced a significant development in the treatment of achondroplasia by submitting a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its investigational drug, TransCon CNP (navepegritide). This application marks a critical advancement in addressing the needs of children afflicted with this rare genetic disorder.Achondroplasia is a hereditary condition characterized by skeletal dysplasia, often leading to disproportionate body growth and various complications affecting health, mobility, and ...
The Efficacy of TransCon CNP (Navepegritide) in Clinical Management: Insights from the Pivotal ApproaCH Trial The recent Pivotal ApproaCH Trial investigating the use of TransCon CNP (Navepegritide) has yielded promising results demonstrating its clinical efficacy in promoting annual growth velocity (AGV) in children with growth impairment. This article synthesizes findings from the trial, emphasizing the statistical significance of TransCon CNP s performance when compared to placebo, alongside discussing its implications for pediatric endocrinology. Growth disorders in children can have profound physical and psychological impacts, necessitating effective therapeutic interventions. Traditional treatments oft...
News U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in adults In a significant development for the treatment of hypoparathyroidism, Ascendis Pharma has announced that its lead product candidate, YORVIPATH (palopegteriparatide), has received orphan drug designation from the U.S. Food and Drug Administration (FDA). This award grants the company seven years of market exclusivity for the medication, which is aimed at addressing the unmet medical needs of adults suffering from this rare endocrine disorder.Hypoparathyroidism is characterized by insufficient secretion of parathyroid hormone, leading to low leve...
Ascendis Pharma A/S (Nasdaq: ASND) has recently announced significant advancements in the field of achondroplasia and chronic hypoparathyroidism. The company presented data from the Phase 2 ACcomplisH trial of TransCon CNP in children with achondroplasia, as well as the latest clinical and quality-of-life data for TransCon PTH-treated adults with chronic hypoparathyroidism. These findings have revealed remarkable improvements in both well-being and physical functioning for patients undergoing treatment with TransCon CNP and TransCon PTH.TransCon CNP in AchondroplasiaAchondroplasia is the most common form of dwarfism, characterized by abnormal bone growth and development. Ascendis Pharma s TransCon CNP (navep...
Ascendis Pharma Extends FDA Review, Expands Market Reach with YORVIPATH, and Unveils Vision 2030In a series of significant developments, Ascendis Pharma A/S (Nasdaq: ASND) has strategically extended its market presence and set ambitious long-term goals while navigating regulatory complexions. The Danish biopharmaceutical leader announced today that the U.S. Food and Drug Administration (FDA) will extend the Prescription Drug User Fee Act (PDUFA) goal date for their novel therapy, TransCon PTH, until August 14, 2024. Concurrently, the company is broadening access to its innovative treatments in Europe and has unveiled an expansive strategic blueprint, Vision 2030, at the 42nd Annual J.P. Morgan Healthcare Co...
Ascendis Pharma Launches 2nd TransCon Product: YORVIPATH Now Available in Germany and Austria for Adults with Chronic HypoparathyroidismCOPENHAGEN, Denmark - Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company specializing in the development of innovative therapies, has recently announced the commercial launch of its second TransCon product, YORVIPATH (palopegteriparatide). Specifically developed as a parathyroid hormone (PTH) replacement therapy, YORVIPATH is indicated for the treatment of adults suffering from chronic hypoparathyroidism. This groundbreaking therapy is now readily available to patients in Germany and Austria.Chronic hypoparathyroidism is a rare endocrine disorder characterized b...
Significant Health and Quality of Life Improvements Achieved in Children with Achondroplasia Treated for One Year with TransCon CNP (Navepegritide) at 100g/kg/weekCOPENHAGEN, Denmark, Dec. 20, 2023 - Ascendis Pharma A/S (Nasdaq:ASND), a leading biopharmaceutical company, has recently announced a series of groundbreaking findings from their Phase 2 clinical trial, ACcomplisH, demonstrating the significant health and quality of life improvements achieved in children with achondroplasia treated with TransCon CNP (Navepegritide) at a dosage of 100g/kg/week for one year. These new analyses provide a glimmer of hope for children suffering from this rare genetic disorder and could transform their lives for the bett...
Ascendis Pharma A’s Comment on Sales, Marketing and Customers
The company provides treatment for adult patients with chronic hypoparathyroidism, marketing TransCon PTH under the name YORVIPATH in the European Union and European Economic Area. This product is approved for use in adults with chronic hypoparathyroidism and has received Orphan status in both the EU and Japan. Clinical development of TransCon PTH included the Phase 3 PaTHway Trial, Phase 3 PaTHway Japan Trial, and Phase 2 PaTH Forward Trial, which collectively involved 141 adult participants with hypoparathyroidism. These trials evaluated treatment efficacy, safety, and improvements in renal function among adults with hypoparathyroidism resulting from post-surgical, autoimmune, genetic, or idiopathic causes.
Sources:
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