Ascendis Pharma A/S (NASDAQ: ASND) presented Tuesday September 15, 2026 at 8:30 a.m. ET at the Morgan Stanley 24th Annual Global Healthcare Conference in New York in a fireside chat format. The presentation followed the ESPE 2026 congress podium delivery September 8 of first Week 52 sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, marketed as YUVIWEL in the U.S.) in 7 infants with achondroplasia aged 0 to under 2 years: 9.9 cm/year annualized growth velocity, +0.42 ACH-specific supine length Z-score, +3.15 mm sagittal foramen magnum increase, and no decompression surgeries at 100 μg/kg/week dosing. The Ascendis TransCon endocrinology franchise reached €315 million in combined Q2 2026 product revenue (+105% year-over-year): YORVIPATH (palopegteriparatide, PTH replacement) €252 million, SKYTROFA (lonapegsomatropin, growth hormone) €55 million, and YUVIWEL (navepegritide, CNP for achondroplasia) €8 million in the first U.S. commercial quarter. The August 31 Ascendis-BioMarin global settlement resolves the YUVIWEL patent overhang (20% U.S. royalties, 18% EU/South Korea/Brazil through May 2030; ITC Section 337 dismissed).
Ascendis Pharma A/S (NASDAQ: ASND) announced Wednesday September 9, 2026 first Week 52 sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release C-type natriuretic peptide prodrug branded YUVIWEL in the U.S. for ages ≥2 years) in 7 treatment-naïve, genetically confirmed infants with achondroplasia aged 0 to under 2 years (mean age 11.7 months). At 100 μg/kg/week once-weekly dosing, the sentinel cohort reached 9.9 cm/year annualized growth velocity through Week 52; ACH-specific supine length Z-score improved by +0.42 from baseline; mean sagittal foramen magnum diameter increased by +3.15 mm with all children stable or improved on the Achondroplasia Foramen Magnum Score, and no decompression surgeries during the treatment period. Safety: no injection-site reactions, no deaths, no fractures, no bone-related events, no symptomatic hypotension. No treatment-related adverse events were reported and no trial discontinuations occurred. Genevieve Baujat MD (Necker Hospital) presented the data as podium abstract FC4.6 on Tuesday September 8. Full reACHin double-blind enrollment is complete with a 52-week extension ongoing. YUVIWEL was FDA-approved February 2026 for ages ≥2 years; the EMA decision on achondroplasia is anticipated Q4 2026.
Ascendis Pharma A/S (NASDAQ: ASND) presented first sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release C-type natriuretic peptide prodrug branded YUVIWEL in the U.S. for achondroplasia in children ≥2 years) in infants aged 0 to under 2 years at the ESPE 2026 congress in Marseille on Tuesday September 8, 2026 (abstract FC4.6, 3:00-4:00 p.m. CEST podium session; Genevieve Baujat MD, Necker Hospital, presenting). The reACHin study completed target enrollment and extends navepegritide's tested age range down to infancy, the population most vulnerable to achondroplasia complications from cervicomedullary compression, foramen magnum stenosis, and delayed motor milestones. Additional ESPE presentations include the HighLiGHts Phase 3 trial design for lonapegsomatropin (TransCon hGH) across Turner syndrome, SHOX deficiency, small-for-gestational-age, and idiopathic short stature; two poster presentations on adolescent hypoparathyroidism patient-reported outcomes; and a systematic literature review on pediatric growth hormone deficiency prevalence. Ascendis' TransCon franchise generated €315 million in Q2 2026 product revenue (+105% year-over-year) with YUVIWEL contributing €8 million in its first U.S. commercial quarter.
Ascendis Pharma A/S (NASDAQ: ASND) announced Monday September 7, 2026 that the first sentinel-cohort data from the Phase 3 reACHin trial of navepegritide (TransCon CNP, a sustained-release CNP peptide prodrug) in infants with achondroplasia aged 0 to under 2 years will be presented as a podium talk at the European Society for Paediatric Endocrinology (ESPE) 2026 congress in Marseille, France (September 8-10). The reACHin presentation (FC4.6) is scheduled for Tuesday September 8, 3:00-4:00 p.m. CEST by Genevieve Baujat MD. Additional presentations include the HighLiGHts Phase 3 trial design for lonapegsomatropin (TransCon hGH) across Turner syndrome, SHOX deficiency, small-for-gestational-age, and idiopathic short stature; hypoparathyroidism patient-reported-outcome data from adolescents; and a systematic literature review on pediatric growth hormone deficiency prevalence. Ascendis submitted the TransCon CNP marketing authorization application to the EMA in October 2025 with an EU decision expected Q4 2026. Navepegritide is engineered to provide continuous CNP receptor stimulation without the peak-and-trough kinetics that constrained earlier vosoritide (Voxzogo) dosing.