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Ascendis Announces COACH Week 78 Results and Provides Update on Achondroplasia Programs and YUVIWEL® Uptake in the U.S.

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  • Week 78 data from the Phase 2 COACH Trial showed durable, unprecedented increases in healthy, proportional growth for TransCon CNP & TransCon hGH combination therapy in children with achondroplasia.
  • TransCon CNP monotherapy Week 104 data from the pivotal ApproaCH Trial demonstrated durable improvements in height, body proportionality, & lower-limb alignment.
  • Target enrollment was completed for the pivotal reACHin Trial, supporting planned regulatory filings for infants aged 0 to <2 years with achondroplasia.
  • Safety & tolerability profiles for both monotherapy & combination therapy remained consistent with previously reported data, featuring low incidence of injection site reactions.
  • More than 170 unique U.S. patient enrollments for YUVIWEL were recorded through June 30, 2026, with over 65% approved for reimbursement.
  • Combination therapy maintained a mean annualized growth velocity (AGV) at or above the 97th percentile of children of average stature, tripling efficacy compared to TransCon CNP monotherapy.
  • Treatment-naïve children in the COACH Trial showed a mean AGV of 7.73 cm/year, while previously treated children showed a mean AGV of 7.67 cm/year at Week 78.
  • 100% of the 21 children enrolled in the COACH Trial completed 78 weeks of combination therapy & remain on treatment.
  • TransCon CNP monotherapy demonstrated significant improvements in tibial-femoral angle & upper-to-lower body segment ratio over 104 weeks, with no symptomatic hypotension reported.
  • 96% of the 140 children enrolled in the AttaCH long-term open-label extension trial remain on TransCon CNP monotherapy or are participating in the COACH combination therapy trial.
  • A regulatory decision for TransCon CNP monotherapy marketing authorization in the European Union is anticipated in the fourth quarter of 2026.
  • TransCon CNP was approved by the FDA under the trade name YUVIWEL in February 2026 for pediatric patients aged 2 years & older with achondroplasia.