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.
Spruce Biosciences, Inc. (NASDAQ: SPRB) has appointed Dr. Will Charlton as Chief Medical Officer following the departure of Dr. Rosh Dias. Dr. Charlton, with over 15 years in clinical research and experience in rare disease drug development, will lead Spruce's clinical strategies, particularly focusing on tildacerfont, aimed at treating classic congenital adrenal hyperplasia and polycystic ovary syndrome.
CEO Javier Szwarcberg expressed confidence in Dr. Charlton's expertise, anticipating significant advancements in therapies for rare endocrine disorders, which have seen no new treatments in nearly 50 years.
Ascendis Pharma announced significant results from the Phase 3 PaTHway Trial of TransCon PTH for adults with hypoparathyroidism. The primary endpoint was achieved by 78.7% of treated patients, compared to 4.8% in the control group (p-value 0.0001). Key secondary endpoints also showed statistically significant improvements in patient-reported symptoms. was well-tolerated, with no discontinuations due to the drug. An NDA is planned for submission in Q3 2022.
Ascendis Pharma announced its full-year financial results for 2021, reporting total revenue of €7.8 million, an increase from €7.0 million in 2020. The company incurred a net loss of €383.6 million, or €7.00 per share, improving from €419.0 million, or €8.28 per share, in the prior year. With cash reserves of €789.6 million, Ascendis continues to advance its pipeline, including TransCon PTH, with Phase 3 results expected soon. The company remains optimistic about a strong 2022, driven by the success of SKYTROFA and a robust oncology pipeline.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on March 2, 2022 at 4:30 p.m. ET to discuss its 2021 financial results and provide a business update. Investors can join via the company’s website, where a replay will be available afterward. The company aims to build a leading biopharma firm using its TransCon technologies to deliver potentially best-in-class therapies. However, the release includes forward-looking statements that highlight substantial risks and uncertainties in achieving their operational goals.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 11th Annual SVB Leerink Global Healthcare Conference. The virtual fireside chat will take place on February 16, 2022, from 3:00 to 3:30 p.m. Eastern Time. A live webcast will be accessible through the Investors and News section on Ascendis Pharma's website, with a replay available for 30 days post-event. Ascendis Pharma focuses on innovative therapies through its TransCon technologies, aiming to enhance patient lives.
Ascendis Pharma announced that the European Commission has granted marketing authorization for TransCon hGH, branded as Lonapegsomatropin, aimed at treating pediatric patients aged 3 to 18 with growth hormone deficiency (GHD). This once-weekly injection offers a sustained release of somatropin, improving treatment adherence. The approval is based on positive results from the Phase 3 trials involving over 300 pediatric patients. The company plans to leverage this approval to enhance its market presence in Europe and develop further products for GHD.
Ascendis Pharma (Nasdaq: ASND) provided updates on its Vision 3x3 and upcoming milestones at the J.P. Morgan Healthcare Conference. CEO Jan Mikkelsen reported strong initial demand for SKYTROFA, the FDA-approved treatment for pediatric growth hormone deficiency, noting a 10% prescription rate among targeted prescribers. In 2022, the company anticipates significant clinical data readouts across its endocrinology and oncology pipeline, alongside the introduction of a third therapeutic area by year-end.
Ascendis Pharma A/S (Nasdaq: ASND) will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022. The event is virtual and begins at 3:00 p.m. Eastern Time. Company executives will provide updates on its pipeline programs and business overview. A live webcast will be available on the Ascendis Pharma website, with a replay accessible for 30 days following the event. This presentation highlights Ascendis' commitment to innovative therapies using its TransCon technologies.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant updates on its investigational products during a virtual R&D Program Update. Key highlights include:
- Phase 3 topline results for TransCon PTH expected in Q1 2022, with NDA and MAA submissions planned for Q3 and Q4 2022, respectively.
- Enrollment completed in Phase 2 ACcomplisH Trial for TransCon CNP, with promising preliminary data guiding dose selection for future trials.
- Early clinical activity observed in cancer patients treated with TransCon TLR7/8 Agonist, indicating potential for further development.
Ascendis Pharma A/S (Nasdaq: ASND) will host a virtual R&D Program Update on December 14, 2021, from 9:00 a.m. to 11:30 a.m. Eastern Time. The event will provide updates on the company's endocrinology rare disease programs and its oncology product, TransCon TLR7/8 Agonist. Key speakers include senior management and Dr. Aliya Khan, a recognized expert in parathyroid disease. Investors can access the live webcast on the company's website, with a replay available for 30 days afterward.