Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States
Ascendis Pharma A/S - American Depositary Shares (ASND)
Last ascendis pharma a/s - american depositary shares earnings: 11/18 04:01 pm
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Source: GlobeNewswire
- YUVIWEL was granted orphan drug exclusivity by U.S. FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses - YUVIWEL is now commercially available in the U.S. with revenue now recognized following approval of first patients and initiation of therapy COPENHAGEN, Denmark, April 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YUVIWEL (navepegritide; developed as TransCon® CNP) was granted orphan drug exclusivity by the U.S. Food & Drug Administration (FDA) and that YUVIWEL is now commercially available in the United States. YUVIWEL is the first and only once-weekly treatment approved by FDA to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and is the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Multiple YUVIWEL prescriptions have already been approved for reimbursement for children in the
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ASND
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- 2/11/26 - Miss
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Sec Filings
- 4/1/26 - Form 3
- 3/30/26 - Form 6-K
- 3/24/26 - Form 6-K
- ASND's page on the SEC website