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 (ASND) announced positive Week 52 data from its pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia. The double-blind placebo-controlled trial, involving 84 children aged 2-11 years, demonstrated superior annualized growth velocity compared to placebo. The drug showed a favorable safety profile with no treatment-related serious adverse events, symptomatic hypotension, fractures, or bone age acceleration.
Key improvements were observed in bone morphometry, including better lower limb alignment, proportional growth, and increased spinal canal dimensions. The trial featured a 2:1 randomization ratio (TransCon CNP:placebo) for 52 weeks, followed by an open-label extension period. The results support the company's goal to provide benefits beyond linear growth and potentially reduce future complications associated with achondroplasia.
Ascendis Pharma (NASDAQ: ASND) released promising 4-year data from its Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. The study demonstrated sustained efficacy with 95% patient retention (56 of 59 patients) at Week 214.
Key findings include: - 98% of patients maintained normal albumin-adjusted serum calcium levels - 93% remained independent from conventional therapy - 67.8% showed clinically meaningful improvement in kidney function (eGFR) - Bone turnover markers stabilized above baseline - Bone mineral density stayed within normal range
The treatment was well-tolerated with mostly mild to moderate adverse events, no serious treatment-related adverse events, and no treatment-related discontinuations.
Ascendis Pharma (Nasdaq: ASND) has scheduled its first quarter 2025 financial results announcement and business update for Thursday, May 1, 2025, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day.
Interested participants can access the live webcast or register for the teleconference through the company's website. A replay will be available in the Investors & News section at investors.ascendispharma.com for 30 days following the event.
Ascendis Pharma (ASND) has submitted a New Drug Application (NDA) to the FDA for TransCon CNP (navepegritide) to treat children with achondroplasia. The submission is supported by data from three randomized, double-blind, placebo-controlled clinical trials with up to three years of open-label extension data.
The treatment, administered once weekly, is designed as a prodrug of C-type natriuretic peptide (CNP) that provides continuous exposure to receptors throughout the body. Clinical data showed multiple benefits including:
- Increased growth velocity
- Reduced health-related burden
- Stronger muscle function
- Straightening of abnormal leg bowing in most treated children
The company plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency during Q3 2025.
Ascendis Pharma A/S (Nasdaq: ASND) has announced its participation in the TD Cowen 45th Annual Health Care Conference. Company executives will engage in a fireside chat scheduled for Tuesday, March 4, 2025, at 11:10 a.m. Eastern Time / 8:10 a.m. Pacific Time in Boston, Massachusetts.
The event will be accessible through a live webcast on the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. For those unable to attend live, a replay of the webcast will be available on the same website for 30 days following the event.
YORVIPATH® (palopegteriparatide) has been registered by Australia's Therapeutic Goods Administration (TGA) as the first and only treatment for chronic hypoparathyroidism in adults. The drug, which received Orphan Drug Designation and Priority Review, represents a significant advancement in treating this rare endocrine disease that affects 6.4-37 per 100,000 people globally.
The approval was supported by the Phase 3 PaTHway trial results, where 93% of YORVIPATH-treated patients achieved independence from both active vitamin D and therapeutic doses of elemental calcium. The drug demonstrated favorable safety profiles, with injection site reactions (21.6%), headache (18.7%), and paraesthesia (13.7%) being the most common adverse reactions.
YORVIPATH will be distributed in Australia by Specialised Therapeutics through an exclusive agreement with Ascendis Pharma, following approvals from the US FDA and EMA. The drug will be reviewed by the Pharmaceutical Benefits Advisory Committee in March 2025 for PBS listing.
Ascendis Pharma A/S (ASND) has announced a comprehensive share management initiative for Q1 2025, involving approximately $25 million in total expenditure. The plan consists of two main components:
1. A Share Repurchase Program of up to $18.25 million in American Depositary Shares (ADSs), which will be executed in compliance with Rules 10b-18 and 10b5-1.
2. A Net Settlement of RSUs involving approximately 450,000 RSUs, requiring about $9 million in cash to cover tax-withholding obligations, which will preserve about 75,000 ADSs as treasury shares.
The combined initiatives aim to preserve approximately 200,000 ADSs as treasury shares. The repurchase program's timing and volume will be based on market conditions and share price, with flexibility to modify or terminate without notice.
Ascendis Pharma (ASND) reported its Q4 and full year 2024 financial results, highlighting strong commercial performance. YORVIPATH achieved 908 prescriptions by Feb. 7, 2025, with full-year 2024 revenue of €28.7 million. SKYTROFA generated approximately €202 million in full-year revenue (excluding prior year adjustments).
The company's total revenue for 2024 reached €363.6 million, up from €266.7 million in 2023, driven by the €91.3 million ($100 million) upfront payment from Novo Nordisk and increased commercial product sales. Operating expenses totaled €598.1 million for 2024. The company reported a net loss of €378.1 million (€6.53 per share) for 2024.
Cash position stood at €559.5 million as of December 31, 2024, with an additional $100 million received from Novo Nordisk in January 2025. The company plans to submit an NDA for TransCon CNP in Q1 2025 for achondroplasia treatment in children.
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