Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA 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
ZORYVE cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trialsRoflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile for up to 56 weeks of treatmentApproximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) 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. “When choosing a therapy for very young children living with AD, healthcare providers and caregivers have to account f
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News
- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) is now covered by analysts at HC Wainwright. They set a "buy" rating and a $19.00 price target on the stock.MarketBeat
- What Awaits These 4 Biotech Stocks That More Than Doubled in 2024 [Yahoo! Finance]Yahoo! Finance
- Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis [Yahoo! Finance]Yahoo! Finance
- Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
- Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
ARQT
Earnings
- 11/6/24 - Beat
ARQT
Sec Filings
- 12/23/24 - Form 4
- 12/20/24 - Form 144
- 12/3/24 - Form 4
- ARQT's page on the SEC website