Once-Weekly TransCon® CNP (Navepegritide) to Receive 10 Years of Market Exclusivity Upon Approval in the European Union
Key Highlights
- ➤10-year EU orphan exclusivity recommended for TransCon CNP upon EC approval
- ➤Q4 2026 European Commission decision expected on TransCon CNP marketing authorization
- ➤Q1 2027 Germany launch planned under the YUVIWEL brand if authorized
- ➤February 2026 FDA approval established YUVIWEL for pediatric achondroplasia in the U.S.
Expert Statements
Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma
“We are pleased to see TransCon CNP recognized as a differentiated treatment able to make a major contribution to patient care for children with achondroplasia”
Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma
“If authorized, we are ready to make this novel medicine available to families and healthcare providers in the European Union seeking to address the medical complications of achondroplasia.”
COPENHAGEN, Denmark, Nov. 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending maintenance of orphan medicinal product designation for once-weekly TransCon CNP (navepegritide) as a treatment for achondroplasia in children. The designation would provide Ascendis benefits that include 10 years of orphan market exclusivity upon final adoption of the COMP opinion by the European Commission (EC).
The opinion follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending marketing authorization for once-weekly TransCon CNP in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed. The final EC decision on Ascendis Pharma’s Marketing Authorisation Application (MAA) is expected during Q4 2026.
Get started
Create a free account to read the full story.