Ascendis Gets EU Committee Backing for Pediatric Achondroplasia Drug
The CHMP recommended authorization of TransCon CNP, with a European Commission decision expected in the fourth quarter of 2026.
Key takeaways
- The CHMP recommended EU marketing authorization for TransCon CNP in eligible children with achondroplasia.
- The European Commission is expected to make a final decision during Q4 2026.
Ascendis Pharma said the EMA’s human medicines committee recommended marketing authorization for its once-weekly TransCon CNP treatment for children with achondroplasia. The recommendation covers children aged two and older whose growth plates have not closed.
The European Commission is expected to make a final decision during the fourth quarter of 2026. If authorization is granted, Ascendis expects its first EU launch, under the YUVIWEL brand, in Germany during the first quarter of 2027.
The committee’s opinion followed a review of the application, which included data from three randomized, placebo-controlled trials and open-label extension data of up to three years. EMA will also review whether the medicine can retain its orphan designation.
As of 12:52 p.m. ET on Oct. 16, Ascendis shares traded at $226.01, down 0.27% since the previous close.
This article was produced with the help of AI technology. Based on reporting by the outlets listed above.
