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 (NASDAQ: ASND) is a global biopharmaceutical company that develops therapies using its proprietary TransCon technology platform. This news page aggregates company announcements, clinical updates, financial results, and regulatory milestones that Ascendis discloses through press releases and regulatory channels.
Readers can follow developments related to Ascendis’ commercial products and pipeline, including YORVIPATH (TransCon PTH) for adults with hypoparathyroidism and SKYTROFA (TransCon hGH) for pediatric and adult growth hormone deficiency. News items also cover investigational programs such as TransCon CNP for children with achondroplasia, combination therapy with TransCon CNP and TransCon hGH in the COACH trial, and TransCon IL-2 β/γ in late-line platinum-resistant ovarian cancer.
Updates frequently include information on Phase 2 and Phase 3 clinical trial results, publication of pivotal data in peer-reviewed journals, submissions and reviews of New Drug Applications and Marketing Authorisation Applications, and presentations at major medical and investor conferences. Financial news, such as quarterly results, revenue contributions from YORVIPATH and SKYTROFA, and commentary on the company’s progress toward its long-term vision, is also reported.
Investors and observers can use this page to monitor how Ascendis advances its TransCon-based portfolio across endocrinology, rare diseases, and oncology, as well as to track collaboration news involving partners in regions such as Greater China and Japan. For those following ASND stock, the news flow provides context on the company’s operational performance, regulatory interactions, and clinical milestones over time.
Ascendis Pharma A/S (Nasdaq: ASND) announced a public offering of $500 million in American Depositary Shares (ADSs), each representing one ordinary share. A 30-day option for underwriters to purchase up to an additional $75 million is also expected. The offering is subject to market conditions and may vary in terms of size and completion. J.P. Morgan, Morgan Stanley, Evercore, and SVB Leerink are managing the offering. The company aims to address unmet medical needs through its innovative TransCon™ technologies and has a pipeline focused on endocrinology and oncology.
Ascendis Pharma A/S (ASND) announced receiving a positive opinion from the Paediatric Committee of the EMA for its TransCon hGH, a treatment for growth hormone deficiency in children aged 6 months to less than 18 years. This opinion supports the completion of the Paediatric Investigation Plan (PIP) based on extensive non-clinical and clinical trial data. The company is set to submit its European marketing application in Q3 2020, with no additional studies required. This marks a potential advancement in the long-acting growth hormone treatment for pediatric patients.
Ascendis Pharma A/S (Nasdaq: ASND) announced the submission of a Biologics License Application (BLA) for TransCon hGH, a long-acting treatment for pediatric growth hormone deficiency (GHD). This marks the first product candidate from the company's innovative TransCon technology to reach BLA submission after multiple Phase 3 trials. TransCon hGH, with orphan designation in the U.S. and Europe, aims to improve patient adherence by replacing daily injections. Future plans include a Marketing Authorisation Application to the European Medicines Agency and further trials in Japan and Greater China.
Ascendis Pharma A/S (Nasdaq: ASND) presented findings from its rare disease endocrinology programs at ENDO Online 2020. The fliGHt Trial showed that patients can safely switch from daily somatropin to TransCon hGH, maintaining consistent efficacy. Interim data from the heiGHt Trial reaffirmed height advantages beyond one year of therapy. The company plans to submit marketing applications in the U.S. this quarter and in Europe by Q3. Additionally, promising data for TransCon PTH highlights its potential as a replacement therapy for hypoparathyroidism.
Ascendis Pharma (ASND) reported its Q1 2020 financial results, revealing a net loss of €63.3 million, or €1.32 per share, versus €53.6 million, or €1.24 per share, in Q1 2019. Revenue dropped to €2.2 million from €5.4 million year-over-year, primarily due to decreased license and service revenue. The company is on track to file a Biologics License Application for TransCon hGH in Q2 and advance its European submission to Q3. Ascendis Pharma ended Q1 with €534.4 million in cash, a decrease from €598.1 million at the end of 2019. R&D expenses rose to €57.5 million, reflecting ongoing product development efforts.
Ascendis Pharma A/S (NASDAQ: ASND) announced a conference call and live webcast on May 19, 2020, at 4:30 p.m. ET to discuss its Q1 2020 financial results and provide a business update. The call can be accessed via a dial-in number or through the company's website, where a replay will be available for 30 days following the event. Ascendis Pharma focuses on innovative therapies using its TransCon™ platform, with ongoing clinical development in endocrinology and oncology.