Ascendis Pharma's TransCon CNP shines in ApproaCH trial results

Ascendis Pharm (NASDAQ:ASND) has announced positive topline data from the pivotal double-blind placebo-controlled ApproaCH Trial of TransCon CNP (navepegritide).

The trial, involving 84 children with achondroplasia, ages 2-11, demonstrated that children treated with TransCon CNP had superior annualized growth velocity (AGV) compared to placebo.

From the result released, children treated with TransCon CNP demonstrated an LS mean AGV of 5.89 cm/year compared to 4.41 cm/year in the placebo arm.

Ascendis plans to submit a New Drug Application to the FDA in Q1 2025 and a Marketing Authorisation Application to the European Medicines Agency in Q3 2025.