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) announced encouraging results from Week 84 of its Phase 2 PaTH Forward Trial for TransCon PTH, an investigational treatment for hypoparathyroidism. The trial observed that 58 out of 59 participants remained in the study, with stable mean serum calcium levels and most participants free from active vitamin D supplementation. TransCon PTH was well-tolerated, with no serious treatment-related adverse events reported. The company expects to release Phase 3 data in Q1 2022, with plans for a potential New Drug Application (NDA) submission if results are positive.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Evercore ISI 4th Annual HealthCONx Conference, scheduled for December 1, 2021. The event is set to be held virtually, with company executives participating in a fireside chat from 3:55 to 4:15 p.m. Eastern Time. A live audio webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma focuses on innovating therapies through its TransCon technologies, aiming to enhance patient outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) announced the completion of its $25 million ADS Share Repurchase Program executed from November 1 to November 9, 2021. The company repurchased a total of 154,837 ADS at a weighted average price of $161.43, totaling $24,999,884. This buyback aims to enhance shareholder value by reducing the number of outstanding shares. The program was conducted under U.S. Securities regulations 10b-18 and 10b5-1.
Ascendis Pharma (ASND) announced a positive opinion from the European Medicines Agency’s CHMP for its growth hormone therapy, TransCon hGH, designed for pediatric patients with growth hormone deficiency. This recommendation supports the marketing authorization application (MAA) with a final decision expected within 67 days. The CHMP's opinion is based on data from three Phase 3 trials involving over 300 patients. Earlier this year, TransCon hGH was also approved by the U.S. FDA under the brand name SKYTROFA.
Ascendis Pharma announced the FDA approval of SKYTROFA® (lonapegsomatropin-tcgd) as a once-weekly treatment for pediatric growth hormone deficiency, launched in October 2021. The company reported a net loss of €80.3 million for Q3 2021, improved from €121.7 million in Q3 2020. Revenue fell to €1.1 million from €2.8 million in the previous year due to decreased sales of clinical supplies. R&D costs decreased to €58.8 million, while selling expenses rose significantly to €39.3 million. Ascendis ended Q3 with cash and equivalents of €929.9 million and plans upcoming clinical updates in December.
Ascendis Pharma (ASND) announced compelling non-clinical results for its investigational TransCon TLR7/8 Agonist at SITC 2021. The results indicate that a single dose activated key immune mechanisms and modulated tumor microenvironments with minimal systemic exposure. The company plans to release initial clinical data for the monotherapy later this quarter. The TransCon TLR7/8 Agonist utilizes innovative hydrogel technology, aimed at sustained immune response, ultimately advancing its ongoing Phase 1/2 study to assess the treatment's safety and efficacy.
Ascendis Pharma A/S (ASND) has announced an update on its $25 million ADS Share Repurchase Program, initiated on November 1, 2021. Under this program, the company has authorized repurchases of up to 300,000 ADSs, with total repurchased shares reaching 122,422 for a total value of approximately $19.76 million. The program will run until December 31, 2021, aiming to enhance shareholder value. The average purchase price per ADS stands at $161.41.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its Q3 2021 financial results and provide a business update. The call will feature insights into the company's progress and performance metrics, with participation via U.S. and international dial-in options. A live webcast will be accessible on the Ascendis Pharma website, with a replay available for 30 days post-event. The company is committed to delivering innovative therapies aimed at improving patient lives using its TransCon technologies.
Ascendis Pharma A/S (Nasdaq: ASND) has launched SKYTROFA (lonapegsomatropin-tcgd), a once-weekly treatment for pediatric patients aged 1 year and older with growth failure due to inadequate secretion of endogenous growth hormone. This FDA-approved therapy replaces daily injections, representing a significant innovation in pediatric care. The company has also introduced the Ascendis Signature Access Program™, providing personalized patient support services. SKYTROFA is expected to enhance the company's growth trajectory as part of its strategic roadmap.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant findings at the ASBMR 2021 Annual Meeting regarding its TransCon PTH product. In a late-breaking presentation, results from the 58-week PaTH Forward Trial were shared, indicating positive trends in calcium homeostasis and improvements in health-related quality of life for hypoparathyroidism patients. The study involved 58 subjects, showing normalization of key biomarkers with mild adverse events reported. The company also highlighted its sponsorship of two CME programs related to hypoparathyroidism and achondroplasia.