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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 participation in two investor conferences this August, providing updates on its pipeline and company overview. The key events are:
- Wedbush PacGrow Healthcare Conference on August 11, 2021, at 9:10 a.m. ET (Virtual)
- Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 11:00 a.m. ET (Virtual)
Live webcasts will be accessible on the Ascendis Pharma website, with replays available for 30 days post-event. The company focuses on innovative therapies addressing unmet medical needs.
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.
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