Ascendis Reports First Week 52 Sentinel-Cohort Data for Navepegritide (TransCon CNP) in Infants With Achondroplasia at ESPE 2026: 9.9 cm/year Growth, +0.42 ACH-Specific Z-Score, +3.15 mm Foramen Magnum, No Decompression Surgeries
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.