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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 announced its participation in ENDO 2024, the annual meeting of the Endocrine Society from June 1-4, 2024, in Boston. They will present their TransCon technology for conditions including growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome.
Key events include the sharing of data from the pivotal foresiGHt trial of TransCon hGH in adults with GHD and an informational booth on hypoparathyroidism coinciding with World Hypoparathyroidism Day. Presentations feature efficacy and safety data for once-weekly Lonapegsomatropin in adults with GHD, pediatric perspectives on once-weekly growth hormone treatments, and baseline demographics from the SkybriGHt Registry Study.
Ascendis Pharma has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for TransCon PTH (palopegteriparatide), a treatment for adults with hypoparathyroidism, by three months to August 14, 2024. This extension follows a major amendment to the New Drug Application (NDA) submitted by Ascendis Pharma. CEO Jan Mikkelsen stated that they have responded to all FDA requests and are committed to working with the agency. Patients currently in clinical trials and the Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant and sustained improvements in renal function for adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide) in a Phase 3 trial. The results showed a mean eGFR increase of 8.9 mL/min/1.73m2 at Week 52 and 9.0 mL/min/1.73m2 at Week 104, with well-tolerated treatment and no new safety concerns.
Ascendis Pharma A/S (Nasdaq: ASND) will present new TransCon PTH data at the European Congress of Endocrinology, showcasing benefits in chronic hypoparathyroidism patients. Key topics include sustained kidney function improvements and quality of life enhancements. The company's presentations highlight the positive impact of TransCon PTH treatment, emphasizing its clinical and quality-of-life benefits.
Ascendis Pharma reported strong financial results for the first quarter of 2024, with notable achievements including the initiation of YORVIPATH® rollout, significant revenue growth for SKYTROFA®, and key milestones for TransCon PTH and TransCon CNP.
Despite positive revenue growth and operational progress, Ascendis Pharma reported increased operating expenses, a net loss, and a decline in net finance income compared to the same period in 2023.
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