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 operates in the rare disease biotechnology sector, where news frequently centers on clinical trial results, regulatory decisions, and product commercialization milestones. The company's focus on pediatric and adult endocrine disorders means that FDA approvals, European Medicines Agency decisions, and clinical data readouts constitute particularly significant news events for investors tracking ASND.
Key news categories for Ascendis Pharma include regulatory milestones such as FDA acceptance of New Drug Applications, priority review designations, and marketing authorization decisions. Clinical trial results from pivotal studies testing the company's TransCon-based therapies provide critical insights into product viability and commercial potential. Quarterly financial reports reveal commercialization progress for approved products like SKYTROFA, including prescription trends and revenue growth in key markets.
Investors following Ascendis Pharma also monitor news about pipeline advancement, including initiation of clinical trials for new indications, enrollment progress in ongoing studies, and publication of clinical data in medical journals. Regulatory interactions, such as FDA Advisory Committee meetings or responses to Complete Response Letters, can significantly impact development timelines. Partnership announcements, manufacturing agreements, and expansion into new geographic markets represent additional news categories relevant to the company's growth strategy.
Conference presentations at major endocrinology and rare disease medical meetings often provide detailed clinical data and expert physician perspectives on Ascendis Pharma's therapies. Investor conferences and earnings calls offer management commentary on commercial execution, competitive dynamics, and strategic priorities. For a biotechnology company with multiple programs in different stages of development and commercialization, tracking this diverse news flow helps investors understand both near-term catalysts and long-term value drivers.
Ascendis Pharma's Phase 2 ACcomplisH Trial data on TransCon CNP for children with achondroplasia was presented at ICCBH 2024. The trial showed significant improvements in well-being and physical functioning compared to placebo at the 100μg/kg/week dose, suggesting benefits beyond linear growth. Conducted in 57 children aged 2-10, the trial's results highlighted TransCon CNP's potential to enhance health-related quality of life. Statistically significant improvements were noted in daily living functioning and emotional well-being, with no serious adverse events reported.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. Company executives will engage in a fireside chat on June 11, 2024, at 8:00 a.m. ET in Miami, Florida. The event will be webcast live on the Ascendis Pharma website, with a replay available for 30 days post-event.
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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