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EMA orphan committee recommends maintaining orphan designation for TransCon CNP

ASNDAscendis Pharma A/S

The Committee for Orphan Medicinal Products of the European Medicines Agency adopted a positive opinion recommending maintenance of orphan medicinal product designation for once-weekly TransCon CNP (navepegritide) as a treatment for achondroplasia in children. This designation provides 10 years of orphan market exclusivity upon final adoption by the European Commission, following a prior CHMP recommendation for marketing authorization. The EC decision is expected during Q4 2026, with a potential EU launch in Germany in Q1 2027 under the brand name YUVIWEL. Ascendis Pharma A/S develops and commercializes therapies for rare diseases.

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