GlobeNewswire·Nov 6, 2026, 8:00 AM ET

Once-Weekly TransCon® CNP (Navepegritide) to Receive 10 Years of Market Exclusivity Upon Approval in the European Union

The Committee for Orphan Medicinal Products (COMP) of the EMA adopted a positive opinion recommending maintenance of orphan medicinal product designation for Ascendis Pharma's once-weekly TransCon CNP (navepegritide).
Final European Commission decision on the orphan designation is expected during Q4 2026, which would grant 10 years of orphan market exclusivity.
The European Commission's final decision on the Marketing Authorisation Application (MAA) for TransCon CNP is also anticipated in Q4 2026.
The EMA's Committee for Medicinal Products for Human Use (CHMP) previously issued a positive opinion recommending marketing authorization for the treatment of achondroplasia in children aged two years and older with open epiphyses.
Ascendis expects the first EU launch of the drug under the brand name YUVIWEL® in Germany during Q1 2027 if authorized.
TransCon CNP is a prodrug designed to provide continuous systemic exposure to active C-type natriuretic peptide (CNP) to counteract overactive FGFR3 signaling in achondroplasia.
The U.S. FDA approved TransCon CNP (YUVIWEL®) in February 2026 for increasing linear growth in pediatric patients 2 years of age and older with achondroplasia.
Achondroplasia is a rare genetic condition affecting over 250,000 people worldwide, caused by an FGFR3 variant leading to skeletal dysplasia and various other medical complications.