TransCon hGH/TransCon CNP combination - (COACH)

August 6, 2026: Ascendis Pharma A/S (NASDAQ: ASND) reported achondroplasia updates for TransCon CNP (navepegritide/YUVIWEL) and TransCon hGH. In the Phase 2 COACH trial, Week 78 data for once-weekly TransCon CNP + TransCon hGH showed durable growth and proportionality benefits with safety consistent with prior monotherapy data. Mean annualized growth velocity remained at or above the 97th percentile for average-stature children; in the TransCon CNP-naïve cohort, AGV was 7.73 cm/year and ACH height Z-score improved +1.29 (0.46 to 1.75), while the TransCon CNP-experienced cohort had AGV of 7.67 cm/year and Z-score improvement of +1.10 (1.28 to 2.38). All 21 enrolled children completed 78 weeks and remain on treatment; additional Week 78 COACH data will be presented at an upcoming medical meeting.

For TransCon CNP monotherapy, Week 104 data from the pivotal ApproaCH trial showed durable gains in height, body proportionality, and lower-limb alignment; children switching from placebo at Week 52 also improved. Through two years, treatment was generally well tolerated, with no discontinuations, no symptomatic hypotension, and mild injection-site reactions at 0.35 per person-year. Ascendis also completed target enrollment in the pivotal reACHin infant trial, continues the teACH adolescent and AttaCH extension studies, and said an EU MAA decision for monotherapy in children is anticipated in Q4 2026. Separately, through June 30, 2026, more than 170 unique U.S. YUVIWEL patient enrollments had been recorded, with over 65% approved for reimbursement.