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 (ASND) delivers innovative biopharmaceutical solutions through its proprietary TransCon platform, focusing on rare endocrine disorders, oncology, and growth-related conditions. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic initiatives.
Access timely reports on ASND's product pipeline including TransCon PTH for hypoparathyroidism and TransCon CNP for achondroplasia. Our curated news collection covers earnings announcements, partnership developments, and European Medicines Agency (EMA)/FDA regulatory interactions, offering critical context for understanding the company's growth trajectory.
Key updates include progress in global clinical trials, manufacturing expansions, and analyses of commercial strategies for approved therapies. Bookmark this page for consolidated access to verified press releases and objective third-party analyses of ASND's position in the competitive biopharma landscape.
Ascendis Pharma A/S (Nasdaq: ASND) will host a conference call and live webcast on April 27, 2023, at 4:30 p.m. ET to discuss its Q1 2023 financial results and provide a business update. Interested participants can access the live event via the company's website. A replay will be available for 30 days post-event. The company is leveraging its innovative TransCon platform technology to advance its biopharmaceutical portfolio, focusing on developing potentially best-in-class therapies. Ascendis operates out of multiple locations, including Denmark and the US, reflecting its global reach and commitment to improving patient outcomes.
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.
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