FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older
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
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) 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 cont
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News
- Pharma Leaders Discuss Managing Revenue Management System Updates at Model N Rainmaker Panel Hosted by RevSavvyPR Newswire
- Ascendis Pharma A/S (ASND) had its "buy" rating reaffirmed by Bank of America Corporation.MarketBeat
- Ascendis Pharma Details Early Q2 YUVIWEL Launch Plan, Pricing Tease at TD Cowen Conference [Yahoo! Finance]Yahoo! Finance
- Ascendis Pharma Maps 2026 U.S. Launch of Once-Weekly YUVIWEL After FDA Approval in Achondroplasia [Yahoo! Finance]Yahoo! Finance
- Ascendis Pharma A/S (ASND) was given a new $332.00 price target by Stifel Nicolaus.MarketBeat
ASND
Earnings
- 2/11/26 - Miss
ASND
Sec Filings
- 3/11/26 - Form 6-K
- 3/9/26 - Form 144
- 3/6/26 - Form 144
- ASND's page on the SEC website