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Ascendis Pharma A/S reports developments as a global biopharmaceutical company applying its TransCon technology platform to new therapies in endocrinology, rare disease and oncology. News commonly centers on TransCon CNP, also known as navepegritide, including YUVIWEL for pediatric achondroplasia, as well as TransCon hGH combination data and growth-disorder clinical programs.
Recurring company updates also include financial results and business updates, U.S. regulatory and commercialization milestones, patient-access programs, and capital-structure actions such as convertible senior note activity. Corporate news also documents the completed transition from American Depositary Shares to ordinary shares trading on Nasdaq under ASND.
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.
Ascendis Pharma (Nasdaq: ASND) has scheduled its second quarter 2025 financial results announcement and business update for Thursday, August 7, 2025, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day.
Investors can access the live webcast through the company's investor relations website, and a replay will be available for 30 days following the event. Participants interested in the teleconference can register in advance through the provided link.
Ascendis Pharma (Nasdaq: ASND) has received FDA approval for SKYTROFA® (lonapegsomatropin-tcgd) for treating adult growth hormone deficiency (GHD). This marks a significant expansion from its 2021 pediatric GHD approval. SKYTROFA is administered once-weekly, offering a less burdensome alternative to traditional daily somatropin injections.
The approval was based on the foresiGHt Phase 3 trial, which demonstrated efficacy and safety compared to placebo and daily somatropin. This milestone aligns with Ascendis's Vision 2030 goal to become the leading endocrinology rare disease company, with plans to initiate additional trials for various conditions in Q4 2025.
Ascendis Pharma (Nasdaq: ASND) announced promising 3-year Phase 3 data for TransCon PTH (palopegteriparatide) in treating adults with hypoparathyroidism. The PaTHway Trial demonstrated significant sustained efficacy with 88% of patients achieving normal calcium levels and 96% becoming independent from conventional therapy at Week 156.
Key outcomes include improved kidney function with mean eGFR increase of 8.76 mL/min/1.73 m2 across all participants, and 13.98 mL/min/1.73 m2 in patients with lower baseline eGFR. The trial showed high retention with 89% completion rate, while demonstrating sustained improvements in patient symptoms and quality of life. The treatment was generally well-tolerated with no new safety concerns identified.