10:06 AM EDT, 09/16/2024 (MT Newswires) -- Ascendis Pharma ( ASND ) said Monday a trial of TransCon CNP, navepegritide, in children with achondroplasia achieved its primary endpoint of improving annualized growth velocity, or AGV, compared to a placebo.

The company said the trial included 84 children with achondroplasia, a type of 'dwarfism,' aged between 2 years and 11 years.

The topline results indicated that children treated with TransCon CNP experienced an AGV improvement of 1.49 cm per year more than those on placebo over 52 weeks, Ascendis said. The AGV of children aged 2 to 5 years was 1.02 cm per year more than placebo, while those aged between 5 years and 11 years showed an improvement of 1.78 cm per year, it added.

Ascendis said the trial indicated "statistically significant improvements" in secondary endpoints.

The treatment was generally well-tolerated with few mild injection site reactions, the company said.

Ascendis said it plans to submit a New Drug Application in Q1 to the US Food and Drug Administration, and a marketing authorization application to the European Medicines Agency in Q3.

Shares of the company were up 18% in recent early Monday trading.

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