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 (ASND) has reached target enrollment for its phase 3 PaTHway Trial, evaluating TransCon PTH for hypoparathyroidism (HP). Top-line data is expected in Q1 2022, with a New Drug Application (NDA) submission planned for mid-2022. The company has received Orphan Drug Designation for TransCon PTH in Japan and established a pathway for global regulatory filings. The trial aims to assess the drug's safety and efficacy in adults with HP, impacting over 400,000 patients across multiple regions.
Ascendis Pharma announced the extension of the PDUFA goal date for its lonapegsomatropin application by three months to September 25, 2021. This extension follows the FDA's classification of the recent submissions as a major amendment to the Biologics License Application (BLA) for treating pediatric growth hormone deficiency (GHD). The company's CEO expressed confidence in the submitted materials, anticipating that the application meets FDA requirements for a thorough review.
VISEN Pharmaceuticals has received IND approval from the CDE of NMPA for the Phase III PaTHway China Trial of TransCon PTH, targeting patients with hypoparathyroidism (HP). This trial aims to evaluate the efficacy of this once-daily hormone replacement therapy, which mimics continuous PTH infusion, to maintain normal serum calcium levels. The study will also collect patient-reported data to enhance understanding of HP's impact on quality of life. Over 200,000 patients globally suffer from HP, and this development marks a significant step in addressing unmet clinical needs in China.
Ascendis Pharma (Nasdaq: ASND) will host an online event on June 1, 2021, to raise awareness for World Hypopara Awareness Day. The event will feature a live reading by bestselling children's author Ariana Feiner, known for her short film documentary, A Story of Courage, which has won 24 international awards. This initiative aims to inspire and support those affected by hypoparathyroidism, a rare condition affecting approximately 200,000 patients in the US and other countries. The event is accessible via www.astoryofcourage.live.
Ascendis Pharma (ASND) announced Q1 2021 results, reporting a net loss of €62.8 million, or €1.17 per share, with revenue decreasing to €0.7 million from €2.2 million year-on-year. The decline in revenue was attributed to lower license revenue and clinical supplies sales. R&D expenses surged to €88.1 million, up from €57.5 million, driven by increased personnel costs and ongoing product development. Cash reserves stood at €771.1 million. The PDUFA date for TransCon hGH is set for June 25, 2021, with a commercial launch anticipated in Q3 2021.
Ascendis Pharma A/S (ASND) announced a conference call on May 27, 2021, at 4:30 p.m. ET to discuss Q1 2021 financial results and provide a business update. The conference will be accessible via a live webcast on the company's website. Ascendis is focused on developing therapies using its TransCon technology for rare diseases and oncology. The company aims to address unmet medical needs and is expanding into new therapeutic areas. The press release highlights Ascendis' commitment to impactful patient care.
Ascendis Pharma has filed a Clinical Trial Notification (CTN) in Japan for the phase 3 PaTHway Japan Trial of TransCon PTH, a potential hormone replacement therapy for hypoparathyroidism. This trial aims to evaluate the safety and efficacy of TransCon PTH in adult patients, contributing to a global program for marketing authorization. The therapy addresses a significant unmet need for patients suffering from this rare endocrine disorder, affecting approximately 200,000 individuals in the U.S., Europe, Japan, and South Korea.
Ascendis Pharma (Nasdaq: ASND) reported preliminary 58-week results from the open-label extension of the PaTH Forward Trial for TransCon PTH, a treatment for hypoparathyroidism. The results show that 91% of the 58 participants were off standard care, maintaining normal urinary calcium levels and experiencing improved quality of life. TransCon PTH was well-tolerated, with no serious adverse events reported. Ascendis plans to conduct a phase 3 trial in Japan and expects topline results from a related study in Q4 2021.
Ascendis Pharma A/S (Nasdaq: ASND) announced the presentation of data for TransCon PTH at two medical conferences. The 48th annual meeting of the European Calcified Tissue Society is set for May 6-8, 2021, followed by the 23rd European Congress of Endocrinology from May 22-26, 2021. The results from the PaTH Forward Trial suggest that TransCon PTH may serve as a first-line hormone replacement therapy for hypoparathyroidism. Oral presentations at both conferences highlight the significance of these findings, which could impact treatment options in endocrinology.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the BofA Securities 2021 Virtual Health Care Conference on May 11, 2021. Company executives will present a business overview and update on its pipeline programs. The event will be held virtually at 4:15 p.m. Eastern Time. A live audio webcast will be accessible on the Company’s website and will be available for replay for 30 days post-event. Ascendis Pharma focuses on utilizing its TransCon technologies to develop therapies for unmet medical needs, currently featuring a pipeline in endocrinology and oncology.