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Ascendis Pharma A/S (NASDAQ: ASND) is a pioneering biotechnology company located at 12 Tuborg Blvd., Hellerup, Capital Region of Denmark, Denmark. Specializing in the development of prodrug therapies, Ascendis Pharma is leveraging its proprietary TransCon technology to create therapies with improved efficacy and safety profiles that address significant unmet medical needs. The company’s diverse product pipeline includes TransCon growth hormone, TransCon peptides, TransCon PTH, and TransCon CNP, among others.
Ascendis Pharma operates across North America, China, and Europe, with the majority of its revenue derived from North American markets. The firm’s flagship product, SKYTROFA, has become the leading growth hormone product by value in the U.S. Ascendis is also rolling out YORVIPATH in Europe, starting with Germany and Austria. In addition, the company is advancing its clinical program for TransCon CNP.
In 2023, Ascendis undertook a significant restructuring to streamline its operations, processes, and expense allocations. President and CEO Jan Mikkelsen maintains that Ascendis is on track to achieve its ambitious Vision 3x3 and Vision 2030 goals, which include achieving blockbuster status for each of its three independent Endocrinology Rare Disease products and expanding its engine for future innovation.
Financially, Ascendis Pharma reported substantial revenue growth in 2023, with total revenue reaching €266.7 million compared to €51.2 million in 2022. This growth was primarily driven by higher SKYTROFA revenue and an upfront payment from Teijin. Research and development (R&D) expenses also increased to €413.5 million in 2023, reflecting ongoing development activities in their TransCon programs. Despite a net loss for the year, the company's financial health remains robust, with cash, cash equivalents, and marketable securities totaling €399.4 million as of December 31, 2023.
Looking ahead, Ascendis Pharma has several key milestones slated for 2024, including the expected commercial launch of TransCon PTH in the U.S. and advancing its oncology and ophthalmology programs. The company also plans to achieve operating cash flow breakeven on a quarterly basis by the end of the year.
Ascendis continues to focus on leveraging its TransCon technology to develop therapies that can make a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis Pharma is committed to becoming a leading, fully integrated biopharma company.
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.
Ascendis Pharma A/S (NASDAQ: ASND) has announced a $25 million share repurchase program aimed at enhancing shareholder value. The program will take place from November 1, 2021, through December 31, 2021, and is managed independently by J.P. Morgan Securities LLC. A maximum of 300,000 American Depositary Shares (ADS) will be repurchased, with a daily limit of 10% of the average trading volume over the last four weeks. Funding will come from existing cash resources, emphasizing the company's commitment to utilizing its financial flexibility for shareholder benefit.
Ascendis Pharma A/S (Nasdaq: ASND) announced positive results from the 58-week Bone Mineral Density (BMD) analysis of the PaTH Forward Trial, a global Phase 2 study of its investigational drug TransCon PTH for adult hypoparathyroidism (HP) patients. Data showed stabilization of BMD Z-scores, indicating potential normalization of calcium metabolism. TransCon PTH, a once-daily injection, aims to restore physiological PTH levels. The trial results align with previous findings on bone turnover markers, reinforcing the therapeutic potential of TransCon PTH in managing HP, a condition affecting approximately 400,000 patients globally.
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