Ascendis Pharma drug gains orphan designation in EU, nearing approval

Investing.com · Vlad Schepkov · 2026-11-06 13:08 UTC

Ascendis Pharma drug gains orphan designation in EU, nearing approval

Ascendis Pharma A/S (Nasdaq: ASND) 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 TransCon CNP (navepegritide) as a treatment for achondroplasia in children.

The designation would provide Ascendis Pharma 10 years of orphan market exclusivity upon final adoption of the opinion by the European Commission (EC). A final EC decision is expected during Q4 2026.

The COMP opinion follows a separate positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended marketing authorization for TransCon CNP in the European Union for the treatment of achondroplasia in children two years of age and older whose epiphyses are not closed.

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