Ascendis Pharma A/S (ASND) Form 6-K — Oct 16, 2026
Ascendis Pharma announced that the EMA's CHMP adopted a positive opinion recommending EU marketing authorization for once-weekly TransCon CNP (navepegritide) to treat achondroplasia in children two years and older with open epiphyses. The positive opinion was based on three randomized, double-blind, placebo-controlled trials plus up to three years of open-label extension data, and TransCon CNP holds orphan medicine designation.
Key figures
- Treatment age
- children two years of age and older whose epiphyses are not closed
- Clinical trials
- three randomized, double-blind, placebo-controlled trials plus up to three years of open-label extension data
- First eu launch
- Germany, Q1 2027 under brand name YUVIWEL
- Ec decision expected
- Q4 2026
AI analysis
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