Shots:
- The EMA has received MAA for TransCon CNP (navepegritide) for the treatment of children with achondroplasia; NDA is under the US FDA’s priority review (PDUFA: Nov 30, 2025)
- MAA is supported by 3 trials assessing TransCon CNP vs PBO & up to 3yrs. of OLE data, incl. ApproaCH trial results in children with achondroplasia, showing favorable tolerability with no study drug–related discontinuations
- TransCon CNP (QW) is a prodrug that delivers sustained CNP exposure to target tissues, such as growth plates and muscle, for continuous inhibition of the overactive FGFR3 pathway to treat achondroplasia
Ref: Ascendis Pharma | Image: Ascendis Pharma| Press Release
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