Business
FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older
The first and only approved achondroplasia therapy to provide continuous systemic exposure to CNP over the weekly dosing intervalCommercial availability expected during early part of Q2 2026Rare Pediatric Disease Priority Review Voucher granted in connection with approvalAscendis 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) ha
About this update from Ascendis Pharma A/s
[{"type":"image","alt":"Ascendis Pharma","displaySize":"","headline":null,"caption":"Ascendis Pharma","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":100,"url":"https://media.zenfs.com/en/globenewswire.com/7afd0e29f0a4b40bcd5ff718a81f4afe"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/1tA.9j4XDPXN.zyLsOvv6w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/7afd0e29f0a4b40bcd5ff718a81f4afe","width":300,"height":100}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"The first and only approved achondroplasia therapy to provide continuous systemic exposure to CNP over the weekly dosing interval","length":129,"tagName":"p"}]},{"val":[{"type":"text","content":"Commercial availability expected during early part of Q2 2026","length":61,"tagName":"p"}]},{"val":[{"type":"text","content":"Rare Pediatric Disease Priority Review Voucher granted in connection with approval","length":82,"tagName":"p"}]},{"val":[{"type":"text","content":"Ascendis to host investor conference call Monday, March 2, at 8:00 am ET ","length":72,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":344,"olType":false},{"type":"text","content":"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 approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s).","length":740,"tagName":"p"},{"type":"text","content":"Achondroplasia is a rare genetic condition causing skeletal dysplasia and, for many affected individuals, an increased risk of muscular, neurological, and cardiorespiratory complications. YUVIWEL is a prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed to provide continuous exposure of active CNP to receptors on tissues througho...