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 (Nasdaq: ASND) will report full year 2025 financial results and provide a business update on Wednesday, February 11, 2026 after U.S. market close. A conference call and live webcast are scheduled for 4:30 p.m. ET, with replay available for 30 days on the investor website.
Ascendis Pharma (Nasdaq: ASND) provided a 2026 business and strategic roadmap, commercial updates, regulatory timelines, and unaudited preliminary 2025 financials ahead of its Jan 12 J.P. Morgan presentation.
Key metrics include YORVIPATH 2025 revenue ~€477M, SKYTROFA 2025 revenue ~€206M, total product revenue ~€683M, total revenue ~€720M, gross margin ~87%, operating expenses ~€762M, cash ~€616M at Dec 31, 2025, and a $120M share repurchase program. Regulatory milestones include a TransCon CNP PDUFA date of Feb 28, 2026 and EMA decision expected Q4 2026.
Ascendis Pharma (Nasdaq: ASND) reported Week 52 topline results from COACH, a Phase 2 trial of once-weekly TransCon CNP plus once-weekly TransCon hGH in children with achondroplasia. Combination therapy produced durable growth: mean annualized growth velocity (AGV) was 8.80 cm/yr in TransCon CNP–naïve children and 8.42 cm/yr in prior TransCon CNP-treated children. ACH height Z-score improved by +1.02 (naïve) and +0.86 (treated). Children exceeded the 97th-percentile AGV for average-stature peers, showed improved body proportionality and arm span (>84th-percentile for achondroplasia), and had bone age consistent with chronological age. Safety was consistent with monotherapies and generally well tolerated; all children completed 52 weeks and remain on therapy.
Ascendis Pharma (Nasdaq: ASND) will present a business update at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 10:30 a.m. ET in San Francisco.
A live webcast will be available via the Investors & News section of Ascendis Pharma's website at investors.ascendispharma.com, and a replay will be posted on the site shortly after the presentation and remain available for 30 days.
Ascendis Pharma (Nasdaq: ASND) said the FDA notified the company that information submitted on Nov 5, 2025 about the post‑marketing requirement for TransCon CNP (navepegritide) constituted a major amendment to the NDA for children with achondroplasia. As a result, the FDA extended the PDUFA goal date by three months to Feb 28, 2026. The company said it has responded to all outstanding FDA requests, including a revised protocol for the post‑marketing study, and is working with the FDA to finalize the remaining elements with the goal of bringing the therapy to U.S. patients as soon as possible.
Ascendis Pharma (Nasdaq: ASND) announced publication in JAMA Pediatrics of pivotal Week 52 results from the randomized, double-blind, placebo-controlled ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia.
Key findings: TransCon CNP produced a statistically higher annualized growth velocity (AGV) at Week 52 versus placebo, improved lower-limb alignment and body proportionality, and showed numerical gains in health-related quality of life with a safety and tolerability profile similar to placebo. The trial enrolled 84 children ages 2–11 randomized 2:1 at 100 μg/kg/week and includes an open-label extension through Week 104. TransCon CNP is under FDA Priority Review with a PDUFA target date of November 30, 2025, and is under review by the European Medicines Agency.
Ascendis Pharma (Nasdaq: ASND) reported third quarter 2025 results with strong commercial momentum and pipeline milestones. Total revenue was €213.6 million for Q3 2025 versus €57.8 million in Q3 2024, driven by commercial product sales. YORVIPATH revenue was €143.1 million (>4,250 unique patient enrollments; >2,000 prescribers) and SKYTROFA revenue was €50.7 million. The company recorded an operating profit of €11.0 million but a net loss of €61.0 million due largely to €60.9 million net finance expense (including a €47.2 million non-cash remeasurement loss). Cash and equivalents were €539 million at Sept 30, 2025. Key regulatory milestones include FDA Priority Review of TransCon CNP with a PDUFA date of Nov 30, 2025 and ongoing EMA review.
Ascendis Pharma (Nasdaq: ASND) reported a pooled 3-year analysis from its Phase 2 PaTH Forward and Phase 3 PaTHway trials showing sustained, clinically meaningful renal improvements with TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism, presented Nov 7, 2025 at Kidney Week 2025.
Key results: mean baseline eGFR 69 (SD 17) mL/min/1.73 m2; mean eGFR change to Year 3 +9.8 (10.9) mL/min/1.73 m2 (PaTH Forward) and +8.8 (11.9) mL/min/1.73 m2 (PaTHway); 70.3% had ≥5 mL/min/1.73 m2 eGFR improvement; ≥91% discontinued conventional therapy; ≥84% maintained normocalcemia. Analysis was post-hoc on 139 patients.
Ascendis Pharma (Nasdaq: ASND) will report third quarter 2025 financial results and provide a business update on Wednesday, November 12, 2025 after the U.S. market close. The company will host a conference call and live webcast on November 12, 2025 at 4:30 p.m. Eastern Time (ET) to discuss results.
Investors may access the live webcast or register for the teleconference via the company's Investors & News website at https://investors.ascendispharma.com. A replay of the webcast will be posted on the same site shortly after the event and will remain available for 30 days.
Ascendis Pharma (Nasdaq: ASND) will share 3-year clinical data showing sustained improvement in renal function, continued normalization of urine calcium handling, and continued safety and efficacy for adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide).
Data come from the Phase 2 PaTH Forward and Phase 3 PaTHway trials through Year 3 and will be presented at Kidney Week 2025 in Houston on November 6, 2025 (Poster #TH-PO0227; abstract in JASN 36(10S); DOI 10.1681/ASN.20253yamgex4).
TransCon PTH is a once-daily prodrug of PTH (1-34) designed to deliver physiological PTH levels and is approved as YORVIPATH in the United States, European Union, and European Economic Area for adults with hypoparathyroidism.
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