TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial - For the TransCon CNP treatment-naïve cohort, combination treatment resulted in mean annualized growth velocity (AGV) of 9.14 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks - For the TransCon CNP-treated cohort, combination treatment resulted in mean AGV of 8.25 cm/year, with an improvement in mean ACH height Z-score of +0.44 over 26 weeks - The combination of TransCon hGH and TransCon CNP demonstrated accelerated...
FDA Accepts TransCon® CNP NDA for Priority Review – Once-weekly TransCon CNP demonstrated significantly higher annualized growth velocity, the primary endpoint, compared to placebo – Multiple benefits beyond linear growth were observed compared to placebo, with a safety and tolerability profile similar to placebo – The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition1 COPENHAGEN, Denmark, June 02, 2025 (GLOBE ...
New Data Shows Improvements in Growth and Bone Morphometry in Children with Achondroplasia Treated with TransCon® CNP (Navepegritide) COPENHAGEN, Denmark, May 13, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data showing improvements in growth and bone morphometry from Week 52 of its pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly providing continuous exposure of active CNP to receptors on tissues throughout the ...
New 4-Year Data Shows Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism COPENHAGEN, Denmark, May 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 214 of its Phase 2 PaTH Forward Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism. Results were shared in an oral presentation today by Andrea Palermo, M.D., from the Campus Bio-Medico University (Rome), during ESPE & ESE 2025, the joint congres...
Ascendis to Share Its Latest Endocrinology Rare Disease Data at ESPE & ESE 2025 COPENHAGEN, Denmark, May 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will share the latest data from its hypoparathyroidism, achondroplasia, and growth hormone deficiency (GHD) programs during ESPE & ESE 2025, the joint congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) being held May 10-13, 2025, in Copenhagen. Four oral presentations will feature Ascendis clinical trial results, including 4-year efficacy...
Ascendis Pharma Reports First Quarter 2025 Financial Results - Q1 2025 revenue of €44.7 million for YORVIPATH® and €51.3 million for SKYTROFA® - TransCon™ CNP NDA submitted in Q1 2025; MAA submission planned in Q3 2025 - Topline COACH combination trial (TransCon CNP + TransCon hGH) data expected in Q2 2025 - Conference call today at 4:30 pm ET COPENHAGEN, Denmark, May 01, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the first quarter ended March 31, 2025, and provided a business update. “The strong...
Ascendis Pharma to Report First Quarter 2025 Financial Results and Provide Business Update on May 1, 2025 COPENHAGEN, Denmark, April 24, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report first quarter 2025 financial results and provide a business update on Thursday, May 1, 2025, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 1, 2025, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2025 financial results. Those who would like to participate may access the live webc...
Ascendis Submits U.S. NDA for TransCon CNP (Navepegritide) for the Treatment of Children with Achondroplasia — Data demonstrated multiple clinical benefits beyond linear growth — NDA supported by data from three randomized, double-blind, placebo-controlled clinical trials in children with achondroplasia, with up to three years of open-label extension data — MAA in EU on track for submission during Q3 2025 COPENHAGEN, Denmark, March 31, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & ...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.