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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 presented promising data on TransCon PTH at the Endocrine Society's annual meeting, highlighting its potential as a hormone replacement therapy for adults with hypoparathyroidism. In a six-month open-label extension of the Phase 2 PaTH Forward Trial, over 90% of 58 subjects achieved independence from conventional treatments, while maintaining normal serum calcium levels. Notably, patient-reported outcomes improved significantly. TransCon PTH remains well-tolerated without serious adverse events. Upcoming PaTHway Trial phase 3 data is expected in Q4 2021, aiming to further assess safety and efficacy.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 11:20 a.m. Eastern Time. The virtual event will feature company executives providing a business overview and updates on its pipeline programs. Ascendis Pharma develops innovative therapies using its TransCon technologies, focusing on endocrinology and oncology. The company continues to expand its product pipeline, which includes three endocrinology rare disease candidates and one oncology candidate in clinical development.
Ascendis Pharma A/S (ASND) announced financial results for 2020, showing a net loss of €419.0 million, or €8.28 per share, compared to €218.0 million in 2019. Revenue decreased to €7.0 million from €13.4 million. R&D expenses rose to €260.9 million, driven by personnel costs and facility expansion. Cash reserves improved to €834.1 million from €598.1 million. Key milestones include preparations for launching TransCon hGH in the U.S. in Q3 2021 and ongoing clinical trials for several product candidates, with important regulatory updates expected in 2021.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in ENDO 2021, showcasing seven presentations on its innovative TransCon™ technologies. Key highlights include the first presentation of 6-month data from the phase 2 PaTH Forward trial for adult hypoparathyroidism, demonstrating the potential of TransCon PTH in reducing standard care treatments while maintaining normal serum calcium. Additionally, two-year follow-up data for TransCon hGH (lonapegsomatropin) shows durable results in children with growth hormone deficiency. The presentations will address significant advancements in endocrinology.
Ascendis Pharma A/S (Nasdaq: ASND) will host a conference call on March 10, 2021, at 4:30 p.m. ET to discuss its 2020 financial results and provide a business update. Investors can access the call via dial-in numbers or a live webcast on the company's website. The firm is advancing its TransCon technologies and currently has a pipeline of three endocrinology rare disease candidates and one oncology candidate in clinical development. Ascendis aims to expand into additional therapeutic areas.
Ascendis Pharma A/S (Nasdaq: ASND) has launched Outgrow GHD, an online resource tailored for caregivers of children with growth hormone deficiency (GHD) in the U.S. The initiative aims to improve awareness and support for families navigating challenges associated with GHD. The platform offers educational materials, tools for engagement, and a quiz to discover parenting styles related to GHD.
The resource highlights the need for community support among families affected by rare diseases and will expand to include additional topics relevant to GHD management.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the SVB Leerink 10th Annual Global Healthcare Conference on February 24, 2021, at 3:40 p.m. Eastern Time. The presentation will include a business overview and an update on the company's product pipeline, which focuses on addressing unmet medical needs using its innovative TransCon technologies. A live webcast of the event will be accessible through the Ascendis Pharma website, with a replay available for 30 days following the event.
Ascendis Pharma A/S (Nasdaq: ASND) provided an update at the J.P. Morgan Healthcare Conference regarding its strategic roadmap, Vision 3x3. The company anticipates significant milestones in 2021, including advancing five independent TransCon product candidates into clinical development. Key highlights include the expected FDA PDUFA date for TransCon hGH on June 25, 2021, and potential MAA approval in Europe for pediatric growth hormone deficiency by Q4 2021. Additionally, clinical trials for TransCon PTH and TransCon CNP are ongoing, with results expected later this year.
VISEN Pharmaceuticals has secured $150 million in Series B funding, led by Sequoia China, to enhance its clinical development and commercialization efforts in Greater China. This financing round attracted participation from notable investors including OrbiMed and Cormorant. The funds will accelerate development of key endocrinology drug candidates like TransCon hGH and TransCon CNP, which address significant unmet medical needs in the region. CEO Pony Lu emphasized the ongoing Phase 3 study and IND approval as milestones for the company's innovative pipeline.
Ascendis Pharma A/S (Nasdaq: ASND) announced a $12.5 million equity investment in VISEN Pharmaceuticals as part of VISEN's $150 million Series B financing. This move is aligned with Ascendis' Vision 3x3 strategy, aimed at enhancing the global reach of its TransCon endocrinology products. Ascendis retains approximately 44% ownership of VISEN post-financing and expects a non-cash gain in Q1 2021. Key leadership from Ascendis will join VISEN's board to streamline collaboration in advancing clinical pipelines.
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