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 (NASDAQ: ASND) is a global biopharmaceutical company that develops therapies using its proprietary TransCon technology platform. This news page aggregates company announcements, clinical updates, financial results, and regulatory milestones that Ascendis discloses through press releases and regulatory channels.
Readers can follow developments related to Ascendis’ commercial products and pipeline, including YORVIPATH (TransCon PTH) for adults with hypoparathyroidism and SKYTROFA (TransCon hGH) for pediatric and adult growth hormone deficiency. News items also cover investigational programs such as TransCon CNP for children with achondroplasia, combination therapy with TransCon CNP and TransCon hGH in the COACH trial, and TransCon IL-2 β/γ in late-line platinum-resistant ovarian cancer.
Updates frequently include information on Phase 2 and Phase 3 clinical trial results, publication of pivotal data in peer-reviewed journals, submissions and reviews of New Drug Applications and Marketing Authorisation Applications, and presentations at major medical and investor conferences. Financial news, such as quarterly results, revenue contributions from YORVIPATH and SKYTROFA, and commentary on the company’s progress toward its long-term vision, is also reported.
Investors and observers can use this page to monitor how Ascendis advances its TransCon-based portfolio across endocrinology, rare diseases, and oncology, as well as to track collaboration news involving partners in regions such as Greater China and Japan. For those following ASND stock, the news flow provides context on the company’s operational performance, regulatory interactions, and clinical milestones over time.
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.
Ascendis Pharma (ASND) announced positive Week 26 topline results from its Phase 2 New InsiGHTS trial, evaluating TransCon hGH (lonapegsomatropin) in Turner syndrome patients. The trial compared three different weekly doses of TransCon hGH against daily somatropin in 49 prepubertal children aged 1-10 years.
The study achieved its primary objective, demonstrating that once-weekly TransCon hGH provided similar growth benefits to daily somatropin, with comparable safety and tolerability profiles. The trial showed improved growth across all three TransCon hGH starting dose cohorts (0.24, 0.30, or 0.36 mg/kg/week), matching the performance of daily somatropin (0.35 mg/kg/week).
Ascendis Pharma (NASDAQ: ASND) announced FDA acceptance of its supplemental Biologics License Application (sBLA) for TransCon hGH to treat adult growth hormone deficiency (GHD), with a PDUFA date set for July 27, 2025. The application is supported by the foresiGHt Phase 3 trial, which evaluated 259 adults with GHD aged 23-80 years.
The trial demonstrated TransCon hGH's superiority in primary and key secondary efficacy endpoints at Week 38, showing significant reduction in trunk fat and increased total body lean mass compared to placebo. The treatment was generally safe and well-tolerated, with no discontinuations related to study drug and comparable safety to daily hGH treatment.