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Ascendis Pharma A/S reports developments as a global biopharmaceutical company applying its TransCon technology platform to new therapies in endocrinology, rare disease and oncology. News commonly centers on TransCon CNP, also known as navepegritide, including YUVIWEL for pediatric achondroplasia, as well as TransCon hGH combination data and growth-disorder clinical programs.
Recurring company updates also include financial results and business updates, U.S. regulatory and commercialization milestones, patient-access programs, and capital-structure actions such as convertible senior note activity. Corporate news also documents the completed transition from American Depositary Shares to ordinary shares trading on Nasdaq under ASND.
Ascendis Pharma (ASND) reported a positive update on its Vision 3x3 strategic plan, spotlighting upcoming milestones for 2023. Key developments include the anticipated launch of TransCon PTH for hypoparathyroidism, with FDA Priority Review due on April 30, 2023. The company also expects topline results from the Phase 3 foresiGHt Trial in Q4 2023 and plans to launch SKYTROFA in Germany by Q3 2023. TransCon CNP's Phase 2 trials show potential for children with achondroplasia, marking advances across its endocrinology, oncology, and ophthalmology pipelines.
Ascendis Pharma announces the opening of the online portal for the Expanded Access Program (EAP) allowing physicians to request access to TransCon PTH for eligible patients in the U.S. This investigational parathyroid hormone replacement therapy is currently under Priority Review by the FDA, with a PDUFA date set for April 30, 2023. Patients eligible for the program must be adults diagnosed with hypoparathyroidism and meet specific inclusion and exclusion criteria. The move aims to address the needs of the hypopara community while awaiting potential FDA approval.
Ascendis Pharma A/S (Nasdaq: ASND) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023. The event takes place in San Francisco, CA, from 12:00 to 12:40 p.m. Eastern Time. A live webcast will be available on the Ascendis Pharma website, with a replay accessible for 30 days post-event. The company focuses on integrating a global biopharma approach using its TransCon platform aimed at developing innovative therapies to improve patient lives.
Ascendis Pharma (ASND) announced an expanded access program for its investigational therapy, TransCon PTH, aimed at patients with hypoparathyroidism in the U.S. The program allows eligible patients, who cannot access other treatments, to request this therapy through their physicians. TransCon PTH is currently under FDA Priority Review, with a target PDUFA date of April 30, 2023. The company emphasizes its commitment to addressing the urgent needs of the hypopara community while underscoring that TransCon PTH's safety and efficacy are not yet established.
Ascendis Pharma (Nasdaq: ASND) will participate in the 5th Annual Evercore ISI HealthCONx Conference on December 1, 2022. The event, hosted virtually, features a fireside chat with the company's executives, scheduled from 1:00 PM to 1:20 PM Eastern Time.
A live webcast will be accessible via the Ascendis Pharma website, with a replay available for 30 days post-event. Ascendis Pharma focuses on innovative therapies using its TransCon technology to enhance patient care, with operations in multiple global locations.
Ascendis Pharma has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for TransCon PTH, a potential first treatment for hypoparathyroidism. This condition affects an estimated 85,000-223,000 patients in Europe and currently lacks effective hormonal replacement therapy. The MAA is based on data from the Phase 3 PaTHway Trial, where 77 out of 79 patients continued treatment, indicating strong efficacy and tolerability. The FDA is currently reviewing TransCon PTH, with a target action date of April 30, 2023.
Ascendis Pharma announced positive topline results from the ACcomplisH Trial, a Phase 2 study evaluating the efficacy of once-weekly TransCon CNP in children with achondroplasia. The trial demonstrated a statistically significant improvement in annualized height velocity (AHV) at 52 weeks for the 100 µg/kg/week dose compared to placebo (p=0.0218). Remarkably, all 57 participants completed the trial, indicating robust tolerability. These findings support further development of TransCon CNP as a treatment option for achondroplasia. Ascendis will discuss these results in a conference call on November 14, 2022.
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.