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 (Nasdaq: ASND) presented new data from the ongoing Phase 1/2 IL-Believe Trial at ASCO 2024. The study evaluates TransCon IL-2 β⁄γ, alone and in combination with TransCon TLR7/8 Agonist, in patients with anti-PD-1 refractory melanoma and other solid tumors.
Key findings include clinical responses in 40% of efficacy-evaluable patients in the initial cohort and 45% in patients with prior disease progression on checkpoint inhibitors. Notably, no new safety signals were reported.
Biomarker analysis linked clinical benefits to CD8+ T cell expansion and activation. The recommended Phase 2 dose is 120 µg/kg administered every three weeks.
Ascendis Pharma announced its participation in ENDO 2024, the annual meeting of the Endocrine Society from June 1-4, 2024, in Boston. They will present their TransCon technology for conditions including growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome.
Key events include the sharing of data from the pivotal foresiGHt trial of TransCon hGH in adults with GHD and an informational booth on hypoparathyroidism coinciding with World Hypoparathyroidism Day. Presentations feature efficacy and safety data for once-weekly Lonapegsomatropin in adults with GHD, pediatric perspectives on once-weekly growth hormone treatments, and baseline demographics from the SkybriGHt Registry Study.
Ascendis Pharma has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for TransCon PTH (palopegteriparatide), a treatment for adults with hypoparathyroidism, by three months to August 14, 2024. This extension follows a major amendment to the New Drug Application (NDA) submitted by Ascendis Pharma. CEO Jan Mikkelsen stated that they have responded to all FDA requests and are committed to working with the agency. Patients currently in clinical trials and the Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant and sustained improvements in renal function for adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide) in a Phase 3 trial. The results showed a mean eGFR increase of 8.9 mL/min/1.73m2 at Week 52 and 9.0 mL/min/1.73m2 at Week 104, with well-tolerated treatment and no new safety concerns.
Ascendis Pharma A/S (Nasdaq: ASND) will present new TransCon PTH data at the European Congress of Endocrinology, showcasing benefits in chronic hypoparathyroidism patients. Key topics include sustained kidney function improvements and quality of life enhancements. The company's presentations highlight the positive impact of TransCon PTH treatment, emphasizing its clinical and quality-of-life benefits.
Ascendis Pharma reported strong financial results for the first quarter of 2024, with notable achievements including the initiation of YORVIPATH® rollout, significant revenue growth for SKYTROFA®, and key milestones for TransCon PTH and TransCon CNP.
Despite positive revenue growth and operational progress, Ascendis Pharma reported increased operating expenses, a net loss, and a decline in net finance income compared to the same period in 2023.
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