Once-Weekly TransCon® CNP (Navepegritide) Receives Positive CHMP Opinion for the Treatment of Achondroplasia in Children
Key Highlights
- ➤CHMP recommends EU marketing authorization for weekly TransCon CNP in children with achondroplasia
- ➤European Commission’s final decision expected during Q4 2026
- ➤Ascendis expects first EU YUVIWEL launch in Germany during Q1 2027
- ➤FDA approved TransCon CNP in February 2026 for pediatric achondroplasia
- ➤TransCon CNP reviewed using three randomized trials and up to three years’ extension data
Expert Statements
Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma
“We are pleased to receive this positive opinion reflecting the unique profile of TransCon CNP. With a highly favorable response from the achondroplasia community to its differentiated profile, TransCon CNP remains a foundational product in our growth disorder portfolio, positioned to support our Vision 2030 objectives.”
COPENHAGEN, Denmark, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for once-weekly TransCon CNP (navepegritide) in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed. The final European Commission (EC) decision on Ascendis Pharma’s Marketing Authorisation Application (MAA) is expected during Q4 2026.
“We are pleased to receive this positive opinion reflecting the unique profile of TransCon CNP,” said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. “With a highly favorable response from the achondroplasia community to its differentiated profile, TransCon CNP remains a foundational product in our growth disorder portfolio, positioned to support our Vision 2030 objectives.”
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