Welcome to our dedicated page for Ascendis Pharma news (Ticker: ASND), a resource for investors and traders seeking the latest updates and insights on Ascendis Pharma stock.
Ascendis Pharma A/S (ASND) delivers innovative biopharmaceutical solutions through its proprietary TransCon platform, focusing on rare endocrine disorders, oncology, and growth-related conditions. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic initiatives.
Access timely reports on ASND's product pipeline including TransCon PTH for hypoparathyroidism and TransCon CNP for achondroplasia. Our curated news collection covers earnings announcements, partnership developments, and European Medicines Agency (EMA)/FDA regulatory interactions, offering critical context for understanding the company's growth trajectory.
Key updates include progress in global clinical trials, manufacturing expansions, and analyses of commercial strategies for approved therapies. Bookmark this page for consolidated access to verified press releases and objective third-party analyses of ASND's position in the competitive biopharma landscape.
Ascendis Pharma A/S (Nasdaq: ASND) announced that the European Commission has granted Orphan Designation to its investigational drug, TransCon PTH, for treating hypoparathyroidism. This long-acting prodrug aims to normalize parathyroid hormone levels, addressing both short-term and long-term symptoms of the condition. Currently, patients are treated with calcium and vitamin D supplements, which are insufficient. The Orphan Designation enhances market exclusivity and reimbursement prospects for the drug, which has also received similar recognition from the U.S. FDA.
Ascendis Pharma A/S (Nasdaq: ASND) announced five presentations highlighting its endocrinology rare disease programs at two online medical conferences: ECTS 2020 (October 22-24) and PENS (November 2-5). Key data includes phase 2 results of TransCon PTH for hypoparathyroidism and phase 3 fliGHt Trial outcomes for TransCon hGH in pediatric growth hormone deficiency. The company aims to enhance clinical outcomes and quality of life for patients. The presentations will showcase a novel auto-injector and research on achondroplasia's impact on children.
Ascendis Pharma A/S (Nasdaq: ASND) has filed a Clinical Trial Notification with Japan's PMDA to initiate the phase 3 riGHt Trial for TransCon™ hGH, targeting pediatric growth hormone deficiency (GHD). This trial is significant as it aims to compare the height velocity of treated Japanese children against a daily hGH formulation, enhancing the product's global reach. The trial involves 40 treatment-naïve children and is expected to support marketing applications in Japan, crucial for expanding Ascendis' product offerings.
Ascendis Pharma A/S (Nasdaq: ASND) has launched the #Together4Growth campaign to raise awareness about children's growth disorders during Children’s Growth Awareness Week, from September 13-19, 2020. This initiative includes a four-question Growth Quiz for parents to identify symptoms and encourages discussion with healthcare professionals. The campaign emphasizes the importance of monitoring growth patterns and will culminate in International Children’s Growth Awareness Day on September 20, 2020. Ascendis Pharma aims to improve life quality for affected children through education and resources.
Ascendis Pharma A/S (Nasdaq: ASND) announced participation in the 18th Annual Morgan Stanley Virtual Global Healthcare Conference, scheduled for September 17, 2020, at 3:30 p.m. Eastern Time. Executives will provide a business overview and update on pipeline programs. The presentation will be accessible via live webcast on the company’s website, with a replay available for 30 days. Ascendis Pharma focuses on developing innovative therapies using its TransCon technologies, with an ongoing pipeline in endocrinology rare diseases and a budding interest in oncology.
Ascendis Pharma A/S (Nasdaq: ASND) announced three presentations for its TransCon PTH program at the ASBMR 2020 Annual Meeting, highlighting a significant phase 2 trial showing that TransCon PTH eliminated standard vitamin D treatment in 82% of participants. This investigational treatment aims to address hypoparathyroidism symptoms effectively. Additionally, a survey revealed that over two-thirds of HP patients experience calcium crashes, demonstrating the need for better treatment options. The meeting runs from September 11-15, with key presentations scheduled for September 15.
Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for TransCon hGH, a once-weekly treatment for pediatric growth hormone deficiency (GHD). This submission follows the EMA's approval of Ascendis' Paediatric Investigation Plan. The MAA includes data from eight clinical trials involving over 400 subjects. Currently, no long-acting growth hormone treatments are approved in Europe for pediatric GHD. TransCon hGH has orphan designation in both the U.S. and Europe.
Ascendis Pharma A/S announced that the FDA accepted its BLA for TransCon hGH, a long-acting prodrug of human growth hormone for treating pediatric growth hormone deficiency (GHD). The PDUFA target date is set for June 25, 2021. Notably, the FDA is not planning to hold an Advisory Committee Meeting regarding this application. TransCon hGH aims to provide a once-weekly injection option, enhancing treatment for clinicians and children. The BLA is backed by results from eight clinical trials involving over 400 subjects. The investigational therapy has received orphan designation in both the U.S. and Europe.
Ascendis Pharma A/S (Nasdaq: ASND) announced two presentations related to its TransCon PTH program for adult hypoparathyroidism at the 22nd European Congress of Endocrinology (e-ECE) 2020. The phase 2 PaTH Forward Trial results showed that 82% of subjects were able to discontinue standard treatments after four weeks of TransCon PTH. The oral presentation is scheduled for September 8, 2020. TransCon PTH is designed as a long-acting hormone replacement therapy, addressing complications from the rare endocrine disorder HP, affecting about 200,000 patients globally.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 2020 Wells Fargo Virtual Healthcare Conference on September 10, 2020, at 4:00 p.m. ET. The conference will showcase a business overview and updates on the company's pipeline programs, focusing on their innovative TransCon™ technologies aimed at addressing unmet medical needs. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma is actively developing therapies for rare endocrine diseases and expanding into oncology.
