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) 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.
Ascendis Pharma (Nasdaq: ASND) has announced it will release its full year 2024 financial results and provide a business update on Wednesday, February 12, 2025, after U.S. market close. The company will host a conference call and live webcast at 4:30 p.m. Eastern Time on the same day to discuss the results. Interested participants can access the webcast directly or register for the teleconference in advance. The webcast will be available for replay on the company's investor relations website for 30 days following the event.
Ascendis Pharma (ASND) provided a business update highlighting strong revenue growth from its two marketed Endocrinology Rare Disease medicines. SKYTROFA achieved ~€202 million in full-year 2024 revenue, with an 84% year-over-year volume increase and 6.5% U.S. market share. YORVIPATH generated ~€29 million in 2024 revenue, with ~700 patients in Europe and 324 patients enrolled in the U.S. program.
The company plans to submit an NDA for TransCon CNP for achondroplasia in Q1 2025 and expand to additional European markets. Total preliminary 2024 revenue is estimated at ~€364 million, including a $100 million Novo Nordisk milestone payment. The company reported a pro forma cash balance of ~€655 million as of December 31, 2024.
Ascendis Pharma A/S (Nasdaq: ASND) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The event will take place on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California.
Company executives will be presenting at the conference, and interested parties can access a live webcast of the presentation through the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. The webcast recording will remain available for 30 days following the event.
Ascendis Pharma (Nasdaq: ASND) has announced the commercial availability of YORVIPATH® (palopegteriparatide) in the United States for treating hypoparathyroidism in adults. YORVIPATH is the first and only FDA-approved medicine for this condition, designed as a once-daily prodrug of parathyroid hormone providing 24-hour continuous exposure to active PTH.
The company has established a dedicated YORVIPATH team within the U.S. Ascendis Signature Access Program® to support patients, offering services including clinical education, prior authorization assistance, injection training, and co-pay support for eligible patients.
