The US FDA has granted accelerated approval to Ascendis Pharma's YUVIWEL (navepegritide, formerly TransCon CNP). It is the first and only weekly medicine to increase linear growth in children from 2 years of age with achondroplasia who have open epiphyses. YUVIWEL is the only therapy that provides continuous systemic exposure to CNP over a weekly dosing interval. The approval is based on safety and efficacy data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data. Key were the results of the pivotal ApproaCH study, published in JAMA Pediatrics, which showed improvement in annual growth velocity (AGV). Continued approval is subject to verification of clinical benefit in confirmatory studies. Ascendis Pharma plans to release YUVIWEL to US physicians in early Q2 2026 and launch the A.S.A.P. to support patients. At the same time, the FDA issued a Priority Review Coupon for rare pediatric diseases.