Welcome to our dedicated page for Ascendis Pharma news (Ticker: ASND), a resource for investors and traders seeking the latest updates and insights on Ascendis Pharma stock.
Ascendis Pharma A/S (NASDAQ: ASND) is a global biopharmaceutical company that develops therapies using its proprietary TransCon technology platform. This news page aggregates company announcements, clinical updates, financial results, and regulatory milestones that Ascendis discloses through press releases and regulatory channels.
Readers can follow developments related to Ascendis’ commercial products and pipeline, including YORVIPATH (TransCon PTH) for adults with hypoparathyroidism and SKYTROFA (TransCon hGH) for pediatric and adult growth hormone deficiency. News items also cover investigational programs such as TransCon CNP for children with achondroplasia, combination therapy with TransCon CNP and TransCon hGH in the COACH trial, and TransCon IL-2 β/γ in late-line platinum-resistant ovarian cancer.
Updates frequently include information on Phase 2 and Phase 3 clinical trial results, publication of pivotal data in peer-reviewed journals, submissions and reviews of New Drug Applications and Marketing Authorisation Applications, and presentations at major medical and investor conferences. Financial news, such as quarterly results, revenue contributions from YORVIPATH and SKYTROFA, and commentary on the company’s progress toward its long-term vision, is also reported.
Investors and observers can use this page to monitor how Ascendis advances its TransCon-based portfolio across endocrinology, rare diseases, and oncology, as well as to track collaboration news involving partners in regions such as Greater China and Japan. For those following ASND stock, the news flow provides context on the company’s operational performance, regulatory interactions, and clinical milestones over time.
Ascendis Pharma A/S (Nasdaq: ASND) announced that initial dose escalation data from its Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ, both alone and with pembrolizumab, has been accepted for online publication at ASCO 2023. TransCon IL-2 β/γ is a long-acting prodrug aimed at overcoming the limitations of current IL-2 therapies, such as short half-life and high Cmax. The trial's primary goals include assessing safety and determining the maximum tolerated dose. If successful, TransCon IL-2 β/γ could become a leading cancer immunotherapy option.
Ascendis Pharma (Nasdaq: ASND) announced that the FDA identified deficiencies in its New Drug Application (NDA) for TransCon PTH, which could delay the regulatory decision. The specific deficiencies were not disclosed. CEO Jan Mikkelsen emphasized the company's commitment to working with the FDA while continuing clinical trials with no new safety signals reported. In parallel, the company is on track for a European Commission decision by Q4 2023 regarding its Marketing Authorisation Application (MAA) for TransCon PTH.
145 of 154 participants in ongoing trials remain treated with TransCon PTH, showcasing the treatment's tolerability.
Ascendis Pharma A/S (Nasdaq: ASND) has announced participation in the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 15, 2023. The virtual fireside chat will feature Jan Mikkelsen, President & CEO, and Scott Smith, EVP & CFO, discussing the company's innovative TransCon platform aimed at creating leading biopharmaceutical therapies. The event takes place from 12:00-12:30 p.m. Eastern Time and will be streamed live on Ascendis Pharma's website. A replay will be available for 30 days post-event.
Ascendis Pharma reported significant financial results for 2022, with total revenue of €51.2 million, up from €7.8 million in 2021. The increase is largely attributed to SKYTROFA U.S. sales reaching €35.7 million. However, the company incurred a net loss of €583.2 million, compared to €383.6 million in 2021. Key milestones include the PDUFA date for TransCon PTH set for April 30, 2023, and an anticipated launch of SKYTROFA in Germany in Q3 2023. The company ended 2022 with €742.9 million in cash and equivalents, down from €789.6 million in 2021, highlighting the need for ongoing funding amidst rising R&D and SG&A expenses.
Ascendis Pharma A/S (Nasdaq: ASND) will host a conference call and webcast on February 16, 2023, at 4:30 p.m. ET to discuss its 2022 financial results and provide a business update. The event can be accessed through their website or by registering for the teleconference. Ascendis utilizes its innovative TransCon platform to develop therapies aimed at improving patient outcomes, positioning itself as a leading global biopharmaceutical company. However, the company warns of risks related to third-party dependencies, unforeseen expenses, and external market factors impacting its operations.
The report titled "Non-Viral / Intracellular Drug Delivery Systems Market" by ResearchAndMarkets.com highlights the rising demand for efficient drug delivery systems in the biopharmaceutical industry. It notes that over 20% of the proteome resides within cell membranes, necessitating innovative delivery methods for therapeutic intervention. Key advancements include non-viral systems such as exosome-based techniques and cell-penetrating peptides. The report reveals that around 1,300 patents have been filed, indicating substantial innovation, with over 20,000 studies on oligonucleotide-based therapeutics underway. The market is expected to grow significantly in the near term.
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.
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