Ascendis said the Committee for Medicinal Products for Human Use adopted a positive opinion on Ascendis’s application seeking approval for the drug in achondroplasia.
- Final European Commission authorization is still pending, with a decision expected in the fourth quarter of 2026 and a potential first launch in Germany in the first quarter of 2027.
- Ascendis has three approved commercial products.
- TransCon CNP, marketed as YUVIWEL in the U.S., received FDA approval in February 2026.
Ascendis Pharma (ASND) said on Friday that it has received a positive European regulatory opinion for its once-weekly treatment for children with achondroplasia.
Shares of the company closed down 0.6%, as investors likely viewed the positive opinion as expected, provided it is already approved in the U.S. TransCon CNP, marketed as YUVIWEL in the U.S., received FDA approval in February 2026 to increase linear growth in children two years and older with open growth plates.
CHMP Opinion On Ascendis Drug
Ascendis said the Committee for Medicinal Products for Human Use adopted a positive opinion on Ascendis’s application seeking approval for the drug in achondroplasia for children two years of age and older whose epiphyses, or the expanded end of a long bone, are not closed.
The opinion followed review of data from three randomized, double-blind, placebo-controlled trials plus up to three years of open-label extension results, including the pivotal ApproaCH trial. Final European Commission authorization is still pending, with a decision expected in the fourth quarter of 2026 and a potential first launch in Germany in the first quarter of 2027.
Chief Executive Officer Jan Mikkelsen said the positive opinion reflects the unique profile of TransCon CNP and that the therapy remains a foundational product in the company’s growth disorder portfolio supporting its longer-term objectives.
Ascendis has three approved commercial products, including TransCon CNP. In the second quarter, or its first quarter of commercial sales, the drug recorded €7.6–8 million in revenue, accounting for a small portion of the company’s overall product revenue of €315 million. YORVIPATH accounts for a lion’s share of the company’s overall sales.
How Did ASND Retail Traders React?
On Stocktwits, retail sentiment around ASND stock stayed within bearish territory over the past 24 hours, while message volume stayed within normal levels.
ASND stock has gained 6% year-to-date.
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