Ascendis Pharma receives positive EU opinion for achondroplasia drug

Ascendis Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorization for TransCon CNP (navepegritide). The once-weekly treatment is intended for children aged two and older with achondroplasia whose epiphyses are not closed.

The CHMP's recommendation follows a review of clinical data from three randomized, double-blind, placebo-controlled trials and up to three years of open-label extension data. A final decision from the European Commission is expected in the fourth quarter of 2026. If authorized, Ascendis plans to launch the drug, under the brand name YUVIWEL, in Germany during the first quarter of 2027.

TransCon CNP previously received FDA approval in the United States in February 2026. Following the announcement, Ascendis Pharma shares closed down 0.6%, as investors appeared to view the regulatory opinion as an expected development given the existing U.S. approval.