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The CHMP has adopted a positive opinion recommending EU marketing authorization for Ascendis Pharma’s once-weekly TransCon CNP (navepegritide) for achondroplasia in children aged ≥2yrs. whose epiphyses are not closed; the EC decision on the MAA is expected in Q4’26
The opinion followed review of the MAA, incl. clinical data from 3 randomized, double-blind, PBO-controlled trials and up to 3yrs. of open-label extension data; pivotal ApproaCH trial data are published in JAMA Pediatrics, & the EMA will review whether the orphan designation can be maintained
TransCon CNP is a once-weekly CNP prodrug designed to provide continuous active CNP exposure to counteract overactive FGFR3 signaling; it was approved by the US FDA as Yuviwel in Feb 2026, & Ascendis expects its first EU launch under the Yuviwel brand in Germany in Q1’27, if authorized
Ref: Ascendis Pharma | Image: Ascendis Pharma | Press Release
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The post Ascendis Pharma’s TransCon CNP (Navepegritide) Receives the CHMP’s Positive Opinion for Achondroplasia in Children appeared first on PharmaShots.
