EMA Panel Backs Ascendis's Yuviwel for Childhood Achondroplasia
ASND sits 22% above its 52-week low of $186.054.
Summary
The EMA's CHMP recommended marketing authorization for Yuviwel (navepegritide) in children with achondroplasia, clearing the final regulatory hurdle before a formal European Commission approval. This is the first regulatory green light for the drug in Europe and follows positive Week 52 reACHin trial data reported in September, which showed TransCon CNP stabilized or improved growth in infants. The recommendation also comes after Ascendis settled all YUVIWEL litigation with BioMarin in late August, removing the main legal overhang on the franchise. For a company with a $14B market cap, a European approval opens a new revenue stream alongside YORVIPATH, which already drove Q2 revenue up 115% year-over-year to €339.3M. The formal EC decision typically follows within 67 days of a positive CHMP opinion.
At the time of this announcement, ASND was trading at $226.62 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $14.1B. The 52-week trading range was $186.05 to $282.15. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.