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) 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.
Ascendis Pharma (NASDAQ:ASND) will present three oral presentations featuring its latest clinical data at the ASBMR 2025 conference in Seattle from September 5-8, 2025. The presentations will showcase new analyses for treatments in achondroplasia and hypoparathyroidism.
Key presentations include:
- New analysis correlating leg bowing improvements with physical functioning in children treated with TransCon CNP
- First presentation of clinical trial data combining TransCon CNP and TransCon hGH therapy in children with achondroplasia
- Clinical data showing 4-year sustained skeletal improvements in adults with hypoparathyroidism treated with TransCon PTH
Ascendis Pharma (Nasdaq: ASND) has announced its participation in the upcoming 2025 Wells Fargo Healthcare Conference. Company executives will engage in a fireside chat scheduled for September 3, 2025, at 8:00 a.m. Eastern Time in Boston, Massachusetts.
Investors can access the presentation through a live webcast on the company's investor relations website. A replay will be available for 30 days following the event.
Ascendis Pharma (NASDAQ:ASND) reported strong Q2 2025 financial results, with total revenue of €158.0 million, a significant increase from €36.0 million in Q2 2024. YORVIPATH® generated €103.0 million in revenue with approximately 3,100 unique patient enrollments, while SKYTROFA® contributed €50.7 million.
Key developments include FDA's priority review of TransCon® CNP (navepegritide) for children with achondroplasia with a PDUFA date of November 30, 2025, and SKYTROFA's U.S. approval for adult growth hormone deficiency treatment. The company reported a net loss of €38.9 million (€0.64 per share) and maintained a strong cash position of €494 million as of June 30, 2025.
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