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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) has filed a Clinical Trial Notification with Japan's PMDA to initiate the phase 3 riGHt Trial for TransCon™ hGH, targeting pediatric growth hormone deficiency (GHD). This trial is significant as it aims to compare the height velocity of treated Japanese children against a daily hGH formulation, enhancing the product's global reach. The trial involves 40 treatment-naïve children and is expected to support marketing applications in Japan, crucial for expanding Ascendis' product offerings.
Ascendis Pharma A/S (Nasdaq: ASND) has launched the #Together4Growth campaign to raise awareness about children's growth disorders during Children’s Growth Awareness Week, from September 13-19, 2020. This initiative includes a four-question Growth Quiz for parents to identify symptoms and encourages discussion with healthcare professionals. The campaign emphasizes the importance of monitoring growth patterns and will culminate in International Children’s Growth Awareness Day on September 20, 2020. Ascendis Pharma aims to improve life quality for affected children through education and resources.
Ascendis Pharma A/S (Nasdaq: ASND) announced participation in the 18th Annual Morgan Stanley Virtual Global Healthcare Conference, scheduled for September 17, 2020, at 3:30 p.m. Eastern Time. Executives will provide a business overview and update on pipeline programs. The presentation will be accessible via live webcast on the company’s website, with a replay available for 30 days. Ascendis Pharma focuses on developing innovative therapies using its TransCon technologies, with an ongoing pipeline in endocrinology rare diseases and a budding interest in oncology.
Ascendis Pharma A/S (Nasdaq: ASND) announced three presentations for its TransCon PTH program at the ASBMR 2020 Annual Meeting, highlighting a significant phase 2 trial showing that TransCon PTH eliminated standard vitamin D treatment in 82% of participants. This investigational treatment aims to address hypoparathyroidism symptoms effectively. Additionally, a survey revealed that over two-thirds of HP patients experience calcium crashes, demonstrating the need for better treatment options. The meeting runs from September 11-15, with key presentations scheduled for September 15.
Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for TransCon hGH, a once-weekly treatment for pediatric growth hormone deficiency (GHD). This submission follows the EMA's approval of Ascendis' Paediatric Investigation Plan. The MAA includes data from eight clinical trials involving over 400 subjects. Currently, no long-acting growth hormone treatments are approved in Europe for pediatric GHD. TransCon hGH has orphan designation in both the U.S. and Europe.
Ascendis Pharma A/S announced that the FDA accepted its BLA for TransCon hGH, a long-acting prodrug of human growth hormone for treating pediatric growth hormone deficiency (GHD). The PDUFA target date is set for June 25, 2021. Notably, the FDA is not planning to hold an Advisory Committee Meeting regarding this application. TransCon hGH aims to provide a once-weekly injection option, enhancing treatment for clinicians and children. The BLA is backed by results from eight clinical trials involving over 400 subjects. The investigational therapy has received orphan designation in both the U.S. and Europe.
Ascendis Pharma A/S (Nasdaq: ASND) announced two presentations related to its TransCon PTH program for adult hypoparathyroidism at the 22nd European Congress of Endocrinology (e-ECE) 2020. The phase 2 PaTH Forward Trial results showed that 82% of subjects were able to discontinue standard treatments after four weeks of TransCon PTH. The oral presentation is scheduled for September 8, 2020. TransCon PTH is designed as a long-acting hormone replacement therapy, addressing complications from the rare endocrine disorder HP, affecting about 200,000 patients globally.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 2020 Wells Fargo Virtual Healthcare Conference on September 10, 2020, at 4:00 p.m. ET. The conference will showcase a business overview and updates on the company's pipeline programs, focusing on their innovative TransCon™ technologies aimed at addressing unmet medical needs. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma is actively developing therapies for rare endocrine diseases and expanding into oncology.
Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Biologics License Application (BLA) for TransCon™ hGH to the FDA for pediatric growth hormone deficiency, with a European Marketing Authorisation Application (MAA) planned for Q3 2020 after EMA approval of the Pediatric Investigation Plan. New trial data showed TransCon PTH significantly improved quality of life for hypoparathyroidism patients. The company reported a Q2 2020 net loss of €94.9 million, a decline from €58.9 million in Q2 2019, with revenue decreasing to €1.4 million from €3.2 million. Cash reserves total €471.6 million.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on August 27, 2020, at 4:30 PM ET to discuss its Q2 2020 financial results and provide a business update. The live webcast will be accessible on the company’s website, with a replay available for 30 days post-event. Ascendis is focused on developing therapies using its TransCon™ technologies, currently advancing three endocrinology product candidates and expanding into oncology. The company emphasizes patient needs and scientific innovation in its mission.
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