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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), a biopharmaceutical company, announced its participation in two investor conferences: the Wells Fargo Healthcare Conference on September 10, 2021, at 2:40 p.m. ET and the Morgan Stanley Global Healthcare Conference on September 15, 2021, at 12:30 p.m. ET. Executives will discuss the company's innovative TransCon™ technologies and provide a business overview. Live webcasts will be available on the Ascendis Pharma website, with replays accessible for 30 days post-event.
Ascendis recently received FDA approval for its product SKYTROFA®.
Ascendis Pharma A/S (NASDAQ: ASND) has submitted an IND application to the FDA for the IL βelieγe trial, a phase 1/2 clinical study of TransCon IL-2 β/γ, aimed at enhancing cancer immunotherapy. This innovative long-acting prodrug is designed to provide sustained release of an IL-2 variant that selectively activates IL-2Rβ/γ while minimizing interaction with IL-2Rα. The company aims to address limitations of existing IL-2 drugs, potentially leading to a more effective cancer treatment.
Ascendis Pharma A/S (Nasdaq: ASND) announced a public offering of 2,500,000 American Depositary Shares (ADSs) at $160.00 each, expected to close around September 7, 2021. The company anticipates net proceeds of approximately $379.3 million, which will be allocated to commercial preparations and clinical development of its products, including lonapegsomatropin-tcgd, palopegteriparatide, and TransCon CNP. Additionally, Ascendis may use funds for working capital and general corporate purposes. Underwriters have a 30-day option to buy up to 375,000 more ADSs.
Ascendis Pharma A/S (Nasdaq: ASND) announced an underwritten public offering of $400,000,000 of American Depositary Shares (ADSs), each representing one ordinary share. The company may grant underwriters a 30-day option to purchase an additional $60,000,000 of ADSs. The offering is subject to market conditions, and there are no guarantees regarding its completion. J.P. Morgan, Morgan Stanley, Evercore, and SVB Leerink are acting as joint book-running managers. A shelf registration statement was filed with the SEC on May 27, 2021.
Ascendis Pharma announced FDA approval of SKYTROFA (lonapegsomatropin-tcgd), a once-weekly treatment for pediatric growth hormone deficiency. The company exceeded enrollment targets for the Phase 3 PaTHway Trial for TransCon PTH and plans to reveal top-line results in Q1 2022. For Q2 2021, Ascendis reported a net loss of €134.4 million, an increase from €94.9 million in Q2 2020, with revenues falling to €1 million. R&D expenses rose to €83.3 million due to higher external development costs. Cash reserves decreased to €641.3 million as of June 30, 2021.
Ascendis Pharma announced the FDA approval of SKYTROFA (lonapegsomatropin-tcgd), the first long-acting growth hormone treatment for pediatric patients aged one year and older with growth failure due to inadequate secretion of endogenous growth hormone. This once-weekly injection demonstrated a higher annualized height velocity (AHV) at week 52 in comparison to daily treatments, potentially reducing the treatment burden for families. The product will soon be available in the U.S. with a suite of patient support programs.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call scheduled for August 25, 2021, at 4:30 p.m. ET to discuss its second quarter 2021 financial results and provide a business update. The call reflects the company's commitment to transparency and communication regarding its performance and strategic direction. Ascendis Pharma focuses on innovative TransCon technologies, enhancing patient outcomes in endocrinology and oncology. The call will be accessible via dial-in and a live webcast on their website.
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.
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