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.
Overview
Ascendis Pharma (ASND) is a biopharmaceutical company headquartered in Copenhagen, Denmark, that leverages its innovative TransCon technology platform to develop new therapies aimed at addressing significant unmet medical needs. Recognized for its work in rare endocrine diseases, oncology, and growth disorders, the company has established itself as a comprehensive drug development organization integrating research, clinical development, and commercialization across a global footprint.
TransCon Technology Platform
The core of Ascendis Pharma's innovation lies in its TransCon technology platform. This proprietary system is strategically designed to create prodrugs that allow for sustained and controlled release of active pharmaceutical ingredients. The platform is pivotal for the development of therapies that require continuous physiological exposure, enhancing the efficacy and safety profiles of interventions for diseases such as hypoparathyroidism and growth hormone deficiencies.
Product Pipeline and Core Therapeutic Areas
Ascendis Pharma's product portfolio is both diverse and robust. Its pipeline primarily focuses on:
- Endocrinology: Developing groundbreaking treatments such as TransCon PTH, a prodrug of parathyroid hormone (PTH [1-34]), aimed at providing sustained exposure in the management of hypoparathyroidism. The company's work in this area addresses the challenges associated with conventional calcium and vitamin D therapies.
- Oncology: Although the company is widely recognized for its endocrine therapies, its research extends into oncology where novel therapeutic approaches are in development.
- Growth Disorders: With programs like TransCon hGH, the company is innovating in the treatment of growth hormone deficiencies in both pediatric and adult populations. The emphasis on reducing dosing frequency and improving patient compliance is a significant aspect of its strategy.
- Skeletal Dysplasias: Ascendis is also advancing therapies for conditions such as achondroplasia with candidates like TransCon CNP, which aim to improve growth outcomes in affected children.
This diverse pipeline is a testament to the company’s expertise in transforming biological mechanisms into effective therapeutic solutions, all while adhering to rigorous standards of safety and efficacy.
Global Presence and Strategic Collaborations
Operating across North America, Europe, and other regions, Ascendis Pharma has cultivated a strong international presence. Its global operations facilitate wide-reaching clinical trials and regulatory engagements, ensuring that its therapies have the potential to address patient needs on a worldwide scale.
Additionally, the company has established important strategic collaborations with other industry leaders. These partnerships not only enhance its research and development capabilities but also enable the sharing of expertise and resources. Such collaborations are critical in the biopharmaceutical landscape, where the integration of diverse scientific insights and commercial strategies drives innovation and market success.
Innovation, Scientific Rigor, and Patient-Centric Approach
At its core, Ascendis Pharma is guided by the principles of Patients, Science, and Passion. The company is dedicated to advancing the science behind its therapies while maintaining a clear focus on improving patient outcomes. Its research strategy involves not only pioneering new therapeutic approaches but also optimizing existing treatments through refined dosing regimens, innovative drug delivery systems, and a deep understanding of disease mechanisms.
This patient-centric approach is supported by robust clinical development programs, which have generated pivotal data across multiple therapeutic areas. The emphasis on sustainability and improved patient quality of life is reflected in the company's continued efforts to offer treatments that are both effective and convenient.
Operational Excellence and Business Model
Ascendis Pharma’s business model is built on rapid, successful drug development that integrates discovery research with clinical and commercial operations. The company invests substantially in R&D to drive the translation of scientific innovation into market-ready therapies. By applying its TransCon platform across various product categories, the company demonstrates a commitment to operational excellence and the efficient use of resources.
Its strategic investments in technology, infrastructure, and cross-functional expertise underscore a model that is both agile and scalable, enabling Ascendis Pharma to navigate the complex regulatory landscapes and capitalize on market opportunities as they arise.
Future-Ready Corporate Culture
Although the content here is designed to be evergreen, it captures Ascendis Pharma’s ongoing mission to not only innovate but also to remain resilient and adaptive in a rapidly evolving industry. With a strong foundation in scientific research, a commitment to operational integration, and a global reach, the company is well-positioned to continue delivering solutions that make a meaningful difference in patient lives.
Conclusion
In summary, Ascendis Pharma stands out in the biopharmaceutical industry through its dedicated application of TransCon technology, its expansive and diverse product pipeline, and its deep-rooted commitment to patient care. The company’s approach of integrating innovative scientific research with extensive global operations provides a comprehensive understanding of how cutting-edge therapies can transform healthcare outcomes. Investors and researchers alike can appreciate the detailed strategy behind Ascendis Pharma’s continued efforts to address rare and challenging health conditions, thereby establishing its significance in today’s competitive market landscape.
Ascendis Pharma (ASND) has submitted a New Drug Application (NDA) to the FDA for TransCon CNP (navepegritide) to treat children with achondroplasia. The submission is supported by data from three randomized, double-blind, placebo-controlled clinical trials with up to three years of open-label extension data.
The treatment, administered once weekly, is designed as a prodrug of C-type natriuretic peptide (CNP) that provides continuous exposure to receptors throughout the body. Clinical data showed multiple benefits including:
- Increased growth velocity
- Reduced health-related burden
- Stronger muscle function
- Straightening of abnormal leg bowing in most treated children
The company plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency during Q3 2025.
Ascendis Pharma A/S (Nasdaq: ASND) has announced its participation in the TD Cowen 45th Annual Health Care Conference. Company executives will engage in a fireside chat scheduled for Tuesday, March 4, 2025, at 11:10 a.m. Eastern Time / 8:10 a.m. Pacific Time in Boston, Massachusetts.
The event will be accessible through a live webcast on the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. For those unable to attend live, a replay of the webcast will be available on the same website for 30 days following the event.
YORVIPATH® (palopegteriparatide) has been registered by Australia's Therapeutic Goods Administration (TGA) as the first and only treatment for chronic hypoparathyroidism in adults. The drug, which received Orphan Drug Designation and Priority Review, represents a significant advancement in treating this rare endocrine disease that affects 6.4-37 per 100,000 people globally.
The approval was supported by the Phase 3 PaTHway trial results, where 93% of YORVIPATH-treated patients achieved independence from both active vitamin D and therapeutic doses of elemental calcium. The drug demonstrated favorable safety profiles, with injection site reactions (21.6%), headache (18.7%), and paraesthesia (13.7%) being the most common adverse reactions.
YORVIPATH will be distributed in Australia by Specialised Therapeutics through an exclusive agreement with Ascendis Pharma, following approvals from the US FDA and EMA. The drug will be reviewed by the Pharmaceutical Benefits Advisory Committee in March 2025 for PBS listing.
Ascendis Pharma A/S (ASND) has announced a comprehensive share management initiative for Q1 2025, involving approximately $25 million in total expenditure. The plan consists of two main components:
1. A Share Repurchase Program of up to $18.25 million in American Depositary Shares (ADSs), which will be executed in compliance with Rules 10b-18 and 10b5-1.
2. A Net Settlement of RSUs involving approximately 450,000 RSUs, requiring about $9 million in cash to cover tax-withholding obligations, which will preserve about 75,000 ADSs as treasury shares.
The combined initiatives aim to preserve approximately 200,000 ADSs as treasury shares. The repurchase program's timing and volume will be based on market conditions and share price, with flexibility to modify or terminate without notice.
Ascendis Pharma (ASND) reported its Q4 and full year 2024 financial results, highlighting strong commercial performance. YORVIPATH achieved 908 prescriptions by Feb. 7, 2025, with full-year 2024 revenue of €28.7 million. SKYTROFA generated approximately €202 million in full-year revenue (excluding prior year adjustments).
The company's total revenue for 2024 reached €363.6 million, up from €266.7 million in 2023, driven by the €91.3 million ($100 million) upfront payment from Novo Nordisk and increased commercial product sales. Operating expenses totaled €598.1 million for 2024. The company reported a net loss of €378.1 million (€6.53 per share) for 2024.
Cash position stood at €559.5 million as of December 31, 2024, with an additional $100 million received from Novo Nordisk in January 2025. The company plans to submit an NDA for TransCon CNP in Q1 2025 for achondroplasia treatment in children.
Ascendis Pharma (Nasdaq: ASND) has announced it will release its full year 2024 financial results and provide a business update on Wednesday, February 12, 2025, after U.S. market close. The company will host a conference call and live webcast at 4:30 p.m. Eastern Time on the same day to discuss the results. Interested participants can access the webcast directly or register for the teleconference in advance. The webcast will be available for replay on the company's investor relations website for 30 days following the event.
Ascendis Pharma (ASND) provided a business update highlighting strong revenue growth from its two marketed Endocrinology Rare Disease medicines. SKYTROFA achieved ~€202 million in full-year 2024 revenue, with an 84% year-over-year volume increase and 6.5% U.S. market share. YORVIPATH generated ~€29 million in 2024 revenue, with ~700 patients in Europe and 324 patients enrolled in the U.S. program.
The company plans to submit an NDA for TransCon CNP for achondroplasia in Q1 2025 and expand to additional European markets. Total preliminary 2024 revenue is estimated at ~€364 million, including a $100 million Novo Nordisk milestone payment. The company reported a pro forma cash balance of ~€655 million as of December 31, 2024.
Ascendis Pharma A/S (Nasdaq: ASND) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The event will take place on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California.
Company executives will be presenting at the conference, and interested parties can access a live webcast of the presentation through the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. The webcast recording will remain available for 30 days following the event.
Ascendis Pharma (Nasdaq: ASND) has announced the commercial availability of YORVIPATH® (palopegteriparatide) in the United States for treating hypoparathyroidism in adults. YORVIPATH is the first and only FDA-approved medicine for this condition, designed as a once-daily prodrug of parathyroid hormone providing 24-hour continuous exposure to active PTH.
The company has established a dedicated YORVIPATH team within the U.S. Ascendis Signature Access Program® to support patients, offering services including clinical education, prior authorization assistance, injection training, and co-pay support for eligible patients.
Ascendis Pharma (ASND) announced positive Week 26 topline results from its Phase 2 New InsiGHTS trial, evaluating TransCon hGH (lonapegsomatropin) in Turner syndrome patients. The trial compared three different weekly doses of TransCon hGH against daily somatropin in 49 prepubertal children aged 1-10 years.
The study achieved its primary objective, demonstrating that once-weekly TransCon hGH provided similar growth benefits to daily somatropin, with comparable safety and tolerability profiles. The trial showed improved growth across all three TransCon hGH starting dose cohorts (0.24, 0.30, or 0.36 mg/kg/week), matching the performance of daily somatropin (0.35 mg/kg/week).
FAQ
What is the current stock price of Ascendis Pharma (ASND)?
What is the market cap of Ascendis Pharma (ASND)?
What is Ascendis Pharma's core business focus?
How does the TransCon technology platform work?
Which therapeutic areas are covered by Ascendis Pharma's pipeline?
What markets does Ascendis Pharma operate in?
How does Ascendis Pharma ensure patient-centric development?
What strategic collaborations support Ascendis Pharma's business model?
