U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
Arcutis Biotherapeutics, Inc. - Common stock (ARQT)
Company Research
Source: GlobeNewswire
U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis (AD) in the United States WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA’s acceptance of a supplemental New Drug Application (sNDA) for?ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The FDA has set a PDUFA target action date of Octobe
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- Arcutis Biotherapeutics (NASDAQ:ARQT) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=ARQT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall SMarketBeat
- Arcutis Strengthens Board of Directors with New Appointment of Amit Munshi and Honors Retirement of Bhaskar ChaudhuriGlobeNewswire
- Arcutis Biotherapeutics: Behind The Big Rally [Seeking Alpha]Seeking Alpha
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Earnings
- 10/28/25 - Beat
ARQT
Sec Filings
- 12/17/25 - Form 4
- 12/15/25 - Form 144
- 12/8/25 - Form 4
- ARQT's page on the SEC website