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 (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.
Ascendis (Nasdaq: ASND) submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for TransCon CNP (navepegritide) as a once‑weekly treatment for children with achondroplasia.
The MAA is supported by data from three randomized, double‑blind, placebo‑controlled trials and up to three years of open‑label extension data, including the pivotal ApproaCH Trial. Ascendis reported TransCon CNP was generally well tolerated with no discontinuations related to the study drug. Ascendis said it will engage with the EMA during review. In the U.S., TransCon CNP is under FDA priority review with a PDUFA target date of November 30, 2025.
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