FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older

Source: The Manila times
Published on: 2026-02-27 23:18

* The first and only approved achondroplasia therapy to provide continuous systemic exposure to CNP over the weekly dosing interval * Commercial availability expected during early part of Q2 2026 * Rare Pediatric Disease Priority Review Voucher granted in connection with approval * Ascendis to host investor conference call Monday, March 2, at 8:00 am ET COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA's Accelerated Approval Program for YUVIWEL® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued app...

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