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On February 27, 2026, the FDA approved Ascendis Pharma’s YUVIWEL (navepegritide) (ASND, Nasdaq, Close: $233.50 - as of Feb. 27, 2026) to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.
Navepegritide is a once-weekly subcutaneous C-type natriuretic peptide prodrug. The FDA granted accelerated approval based on improved annualized growth velocity, supported by the pivotal ApproaCH study at Week 52 with a 1.49 cm/year least-squares mean difference versus placebo.
“The approval of once-weekly YUVIWEL is a major step forward in the treatment of children with achondroplasia, giving physicians for the first time the option of prescribing a once-weekly medicine...,” said Carlos A. Bacino, MD, FACMG, of Baylor College of Medicine and Texas Children’s Hospital.
Ascendis Pharma’s CEO, Jan Mikkelsen, underscored that: “We have listened to advocacy groups for people with dwarfism to ensure we address what the community actually cares about,” calling the approval “a new way to look at the promise of pharmacological treatment options.”
The label warns of low blood pressure, and, clinically, it adds another subcutaneous option for achondroplasia in the approved population.
Sources: Prescribing information – Yuviwel (navepegritide) ; Ascendis Pharma press release – Yuviwel – 02/27/2026
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