MILPITAS, Calif. – ASC Therapeutics, a privately-held biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies for hematologic and other rare disorders today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for ASC618, an...
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COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide)...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements...
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...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced three oral presentations of its latest achondroplasia and hypoparathyroidism data at ASBMR 2025, the annual meeting of the American Society for Bone & Mineral Research being held in Seattle from September 5-8, 2025. These include a new analysis of pivotal...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon CNP (navepegritide) as a treatment for children with achondroplasia, a rare genetic condition that causes skeletal dysplasia and, for many affected individuals, significant health,...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered...
SUZHOU, China and ROCKVILLE, Md. — Ascentage Pharma a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that Prof. Xiaoyuan Gong of the Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences, has presented the preliminary results from...
ROCKVILLE, Md. and SUZHOU, China — Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance from the US Food and Drug...