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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 (Nasdaq: ASND) has provided new data from the Phase 1/2 transcendIT-101 trial of TransCon TLR7/8 Agonist for advanced solid tumors. Results show early signs of clinical activity when used alone or with pembrolizumab, along with no systemic toxicity. The treatment demonstrated sustained immune system engagement after one injection. The recommended Phase 2 dose was established at 0.5 mg/lesion. Ongoing trials will further investigate its efficacy against various cancer types. Results were presented at the Society for Immunotherapy of Cancer annual meeting.
Repertoire Immune Medicines has appointed Torben Straight Nissen as the new interim CEO, shifting focus to its DECODE™ Platform aimed at developing immune medicines for cancer, autoimmune disorders, and infectious diseases. This transition follows the discontinuation of Phase 1 clinical studies for certain T cell therapeutic candidates. The company aims to leverage insights from previous studies while reducing operational needs, including a staff reduction. The DECODE platform enables the identification of key immune interactions, emphasizing its potential in innovative treatment solutions.
Ascendis Pharma (ASND) reported third-quarter 2022 revenue of €15.3 million, a significant rise from €1.1 million year-over-year, driven by SKYTROFA® sales of €12.3 million. R&D expenses rose to €97.4 million, reflecting a strategic focus on upcoming product launches, particularly TransCon PTH, which is under FDA Priority Review with a PDUFA date of April 30, 2023. The net loss for the quarter was €169.0 million or €3.03 per share. Despite increased operational costs, Ascendis ended the quarter with a robust cash position of €935.1 million, supporting ongoing development initiatives.
Ascendis Pharma A/S (Nasdaq: ASND) announced that the FDA has accepted its New Drug Application for TransCon PTH, targeting adults with hypoparathyroidism, under Priority Review. The decision has a PDUFA target action date of April 30, 2023. Ascendis also plans to submit a Marketing Authorisation Application to the EMA this quarter. Hypoparathyroidism affects approximately 200,000 patients in the U.S., Europe, and Japan, with conventional therapies being inadequate. The company aims to make TransCon PTH the first hormone replacement therapy for this condition.
Ascendis Pharma A/S (Nasdaq: ASND) will conduct a conference call and live webcast on November 2, 2022, at 4:30 p.m. ET to discuss its third quarter 2022 financial results and provide a business update. Interested participants can access the webcast through the provided links on the company's website, where a replay will be available for 30 days. Ascendis Pharma focuses on utilizing its innovative TransCon™ platform to develop new therapies aimed at making a positive impact on patients' lives.
Frazier Life Sciences has appointed Jan Møller Mikkelsen as a Senior Advisor, enhancing its leadership team. Mikkelsen, with over 30 years in the biopharmaceutical sector, is the founder and CEO of Ascendis Pharma (NASDAQ: ASND) and has held senior positions at several notable companies. Frazier Life Sciences, managing over $3.3 billion in capital, focuses on innovative biopharmaceutical investments, boasting 62 portfolio companies that have achieved IPOs or M&As since 2005.
Ascendis Pharma announced positive early results from the Phase 1/2 transcendIT-101 trial for TransCon TLR7/8 Agonist, showing it is well-tolerated with signs of clinical activity in advanced solid tumors. The recommended Phase 2 dose will be evaluated across four specific cancer cohorts, including melanoma and head and neck squamous-cell carcinoma. An abstract of the topline data will be presented at the SITC 2022 meeting in Boston on November 8-12. The trial aims to leverage the body’s immune system to improve cancer therapy outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) reported promising Week 110 data from the Phase 2 PaTH Forward Trial for TransCon PTH, an investigational treatment for hypoparathyroidism. The results demonstrated sustained normalization of serum calcium levels, with 93% of participants achieving independence from conventional therapy. The therapy was well-tolerated, and there were no discontinuations due to adverse events. Additionally, there was a notable improvement in bone mineral density, trending toward age- and sex-matched norms. Ascendis plans to submit a Marketing Authorisation Application to the EMA in Q4 2022.
Ascendis Pharma A/S (Nasdaq: ASND) will participate in three investor conferences in September 2022. The events include Citi's 17th Annual BioPharma Conference on September 7 in Boston, the Wells Fargo Healthcare Conference on September 8 in Boston, and the Morgan Stanley 20th Annual Global Healthcare Conference on September 13 in New York. Scott Smith, CFO, will speak at the first two conferences, while both Scott Smith and CEO Jan Mikkelsen will present at the last conference. Live webcasts will be available on Ascendis' website.
Ascendis Pharma has submitted a New Drug Application (NDA) for TransCon PTH to the FDA, targeting hypoparathyroidism. If approved, it could be the first hormone replacement therapy addressing the root cause of this condition affecting approximately 70,000-90,000 adults in the U.S. The NDA is based on positive Phase 2 and Phase 3 trial data showing that treated patients achieved normalization of serum calcium levels and reported improved quality of life. The company also plans to submit a Marketing Authorisation Application to the European Medicines Agency in Q4 2022.
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