Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia [Yahoo! Finance]
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: Yahoo! Finance
COPENHAGEN, Denmark, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA's ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.
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- Former Novo Nordisk Executive Jesper Høiland Joins Alva Therapeutics' Board of DirectorsPR Newswire
- Ascendis Pharma (ASND): Is There More Upside in the Valuation After Recent Momentum? [Yahoo! Finance]Yahoo! Finance
- How the FDA's TransCon CNP Review Delay at Ascendis Pharma (ASND) Has Changed Its Investment Story [Yahoo! Finance]Yahoo! Finance
- How Analyst Views Are Shifting the Ascendis Pharma Story After Recent Yorvipath and Pipeline Updates [Yahoo! Finance]Yahoo! Finance
- Ascendis Pharma A/S (NASDAQ:ASND) had its "overweight" rating reaffirmed by analysts at Cantor Fitzgerald.MarketBeat
ASND
Earnings
- 11/12/25 - Miss
ASND
Sec Filings
- 12/4/25 - Form 144
- 12/2/25 - Form 144
- 12/2/25 - Form 144
- ASND's page on the SEC website