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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 (Nasdaq: ASND) announced that YUVIWEL (navepegritide) received U.S. FDA orphan drug exclusivity and is now commercially available in the United States.
The FDA approved YUVIWEL on Feb 27, 2026 under accelerated approval to increase linear growth in children ≥2 years with achondroplasia with open epiphyses; orphan exclusivity runs through Feb 27, 2033. Ascendis reports revenue recognition following approval of first patients and therapy initiation and has launched the Ascendis Signature Access Program (A.S.A.P.) to support access and reimbursement.
Ascendis Pharma (Nasdaq: ASND) reported Week 52 topline results from New InsiGHTS, a Phase 2 randomized, open-label trial in 49 prepubertal children with Turner syndrome.
TransCon hGH (lonapegsomatropin) produced an LS mean annualized height velocity of 9.05 cm/year, versus 9.04 cm/year for daily somatropin, with comparable safety and no SCFE occurrences through up to 143 weeks follow-up.
Ascendis Pharma (Nasdaq: ASND) shared two-year data from the pivotal ApproaCH Trial showing once-weekly TransCon CNP (navepegritide) sustained linear growth benefits through Week 104 and further improved body proportionality in children with achondroplasia.
Key facts: randomized trial in 84 children (2–11 years), upper-to-lower segment ratio improved from -0.04 at Week 52 to -0.10 at Week 104, 80 of 84 completed the trial, FDA approved YUVIWEL in Feb 2026, EMA decision expected Q4 2026, tolerability was generally favorable with no symptomatic hypotension and injection-site reactions at 0.35 per person-year.
Ascendis Pharma (Nasdaq: ASND) will participate in a virtual fireside chat at the TD Cowen 46th Annual Health Care Conference on March 2, 2026 at 11:10 a.m. ET.
A live webcast and a replay available for 30 days will be accessible via the companys Investors & News website at investors.ascendispharma.com.
Ascendis Pharma (Nasdaq: ASND) announced FDA accelerated approval of YUVIWEL (navepegritide), the first and only once-weekly therapy to provide continuous systemic exposure to CNP for children with achondroplasia aged 2 years and older with open epiphyses. Continued approval may require confirmatory trials.
Commercial availability is expected in early Q2 2026 and a Rare Pediatric Disease Priority Review Voucher was issued.
Ascendis Pharma (Nasdaq: ASND) reported Q4 2025 product revenue of €240 million and full‑year 2025 product revenue of €684 million. Q4 operating profit was €10 million with operating cash flow of €73 million. Full‑year net loss was €228 million and cash totaled €616 million. Key pipeline milestones include a PDUFA action date of Feb 28, 2026 for TransCon CNP (pediatric achondroplasia) and ongoing TransCon PTH and TransCon hGH label-expansion programs.
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.