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Ascendis reports COACH trial Week 78 data and Yuviwel uptake

August 6, 2026 8:01 AM

Ascendis Pharma A/S (Nasdaq: ASND) released Week 78 data from its Phase 2 COACH trial and provided updates on its achondroplasia programs, according to a company statement.

In the COACH trial, children with achondroplasia treated with a combination of once-weekly TransCon CNP and once-weekly TransCon hGH maintained a mean annualized growth velocity (AGV) at or above the 97th percentile of children of average stature through Week 78. In the treatment-naïve cohort, mean AGV was 7.73 cm/year, with a mean ACH height Z-score increase of +1.29 over 78 weeks. In the TransCon CNP-experienced cohort, mean AGV was 7.67 cm/year, with a mean ACH height Z-score improvement of +1.10. All 21 enrolled children completed 78 weeks and remain on therapy.

Week 104 data from the pivotal ApproaCH trial of TransCon CNP monotherapy showed durable improvements in height, lower-limb alignment, and body proportionality. Most adverse events were mild or moderate, with no treatment discontinuations and an injection-site reaction rate of 0.35 per person-year of exposure.

Ascendis also reported it completed target enrollment for the pivotal reACHin trial, which supports planned regulatory filings for infants aged 0 to under 2 years with achondroplasia. A Marketing Authorisation Application decision for TransCon CNP in the European Union is anticipated in the fourth quarter of 2026.

Regarding the U.S. commercial launch of Yuviwel (navepegritide), Ascendis reported more than 170 unique patient enrollments by approximately 90 prescribing healthcare providers through June 30, 2026, with more than 65% of those patients approved for reimbursement. All enrollments through that date represent patients new to Yuviwel therapy. Yuviwel received U.S. Food and Drug Administration approval in February 2026 for increasing linear growth in pediatric patients 2 years of age and older with achondroplasia.

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