Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary ... - Stock Titan
Ascendis Pharma announced positive topline data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) for children with achondroplasia, demonstrating superior annualized growth velocity (AGV) compared to placebo: 1.49 cm/year overall (p<0.0001), 1.78 cm/year for ages 5-11 (p<0.0001), and 1.02 cm/year for ages 2-<5 (p=0.0084). TransCon CNP also improved height Z-scores and quality of life measures, with a safety profile comparable to placebo. Ascendis plans to submit an NDA to the FDA in Q1 2025 and an MAA to the EMA in Q3 2025.
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Ascendis Pharma announced positive topline data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) for children with achondroplasia, demonstrating superior annualized growth velocity (AGV) compared to placebo: 1.49 cm/year overall (p<0.0001), 1.78 cm/year for ages 5-11 (p<0.0001), and 1.02 cm/year for ages 2-<5 (p=0.0084). TransCon CNP also improved height Z-scores and quality of life measures, with a safety profile comparable to placebo. Ascendis plans to submit an NDA to the FDA in Q1 2025 and an MAA to the EMA in Q3 2025.