Once-Weekly TransCon® CNP (Navepegritide) Receives Positive CHMP Opinion for the Treatment of Achondroplasia in Children
Key Highlights
- ➤CHMP recommends EU marketing authorization for once-weekly TransCon CNP in children
- ➤European Commission decision on TransCon CNP expected in Q4 2026
- ➤Ascendis expects first EU YUVIWEL launch in Germany during Q1 2027
- ➤TransCon CNP received FDA approval in February 2026
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”
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.”
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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