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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) 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.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 39th Annual J.P. Morgan Healthcare Conference to be held virtually on January 11, 2021, at 11:40 a.m. Eastern Time. During the event, company executives will provide an overview and updates on the company's pipeline programs, which focus on addressing unmet medical needs through innovative TransCon technologies. The webcast will be accessible on the company's website, with a replay available for 30 days following the conference.
Ascendis Pharma A/S (Nasdaq: ASND) announced the filing of an investigational new drug (IND) application for its TransCon TLR7/8 Agonist with the U.S. FDA. This long-acting prodrug is designed for intratumoral injection, aiming to offer sustained release of resiquimod, enhancing immune response against cancer while minimizing systemic exposure. The company emphasizes this milestone as a potential shift in cancer treatment, leveraging the immune system to target tumors more effectively.
Ascendis Pharma (Nasdaq: ASND) announced a board transition with Michael Wolf Jensen stepping down as Chair at the 2021 AGM but remaining as SVP and Chief Legal Officer. The Board intends to appoint Dr. Albert Cha as the new Chair. Jensen has been with the company since 2008, guiding its transformation into a global organization. Dr. Cha has been on the Board since 2014 and has experience in healthcare investment. Ascendis continues to innovate with its TransCon technologies, focusing on rare diseases and expanding into oncology.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Evercore ISI 3rd Annual HealthCONx Virtual Conference on December 3, 2020. Executives will provide an update on the company's pipeline and business overview. The event will be streamed live, with a replay available for 30 days on the company’s website. Ascendis is focused on developing innovative therapies using its TransCon technologies, currently advancing clinical programs in endocrinology and oncology, while expanding into additional therapeutic areas to address unmet patient needs.
Ascendis Pharma A/S (Nasdaq: ASND) announced its upcoming virtual Oncology R&D Day on November 20, 2020, at 12:00 p.m. ET. The event will showcase the application of its innovative TransCon™ technology platform to oncology, highlighting the company’s strategy and developments in creating new cancer therapies. Key focuses include updates on TransCon TLR7/8 Agonist and TransCon IL-2 β/γ programs, which aim to activate immune responses in cancer treatment. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-event.
Ascendis Pharma announced the validation of its Marketing Authorisation Application (MAA) for TransCon hGH (lonapegsomatropin) in pediatric growth hormone deficiency by the European Medicines Agency (EMA). The company has also submitted regulatory filings for the phase 3 PaTHway Trial of TransCon PTH in Europe and Canada, and initiated a phase 2 trial for TransCon CNP in collaboration with VISEN Pharmaceuticals. Ascendis reported a net loss of €121.7 million for Q3 2020, with revenues increasing to €2.8 million. Cash reserves stand at €957.5 million as of September 30, 2020.
Ascendis Pharma A/S (Nasdaq: ASND) has appointed Mark A. Bach, M.D., Ph.D., as Senior Vice President of Clinical Development and Medical Affairs focusing on endocrine rare diseases. His extensive experience in clinical research and development is expected to bolster the company's investigational product pipeline, particularly as it prepares for the potential launch of its first product targeting pediatric growth hormone deficiency. The company utilizes its proprietary TransCon technology to develop innovative therapies aimed at unmet medical needs in endocrinology.
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