Ascendis Submits U.S. NDA for TransCon CNP (Navepegritide) for the Treatment of Children with Achondroplasia
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
— Data demonstrated multiple clinical benefits beyond linear growth — NDA supported by data from three randomized, double-blind, placebo-controlled clinical trials in children with achondroplasia, with up to three years of open-label extension data — MAA in EU on track for submission during Q3 2025 COPENHAGEN, Denmark, March 31, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly and designed to treat individuals with achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body, including growth plates and skeletal muscle. The filing is based on data from three randomized, double-blind, placebo-controlled clinical trials and u
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Earnings
- 11/12/25 - Miss
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Sec Filings
- 12/10/25 - Form 6-K
- 12/4/25 - Form 144
- 12/2/25 - Form 144
- ASND's page on the SEC website