Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children


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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