Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
Arcutis Biotherapeutics, Inc. - Common stock (ARQT)
Company Research
Source: GlobeNewswire
Submission supported by data from INTEGUMENT-INFANT Phase 2 open-label study in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitisOnce-daily ZORYVE cream was well tolerated with a safety profile consistent with that in older children and adultsAtopic dermatitis impacts 1 million children under the age of 2 in the United StatesOnly one other FDA-approved topical non-steroidal anti-inflammatory agent available for this vulnerable population WESTLAKE VILLAGE, Calif., April 27, 2026 (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) seeking to expand the indication for ZORYVE® (roflumilast) cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months. “At
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News
- Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months [Yahoo! Finance]Yahoo! Finance
- A Look At Arcutis Biotherapeutics (ARQT) Valuation After Recent Share Price Moves [Yahoo! Finance]Yahoo! Finance
- Arcutis’ ZORYVE® (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis GuidelinesGlobeNewswire
- Arcutis Biotherapeutics (ARQT) Presents Positive Phase 2 Data for ZORYVE Cream in Infants [Yahoo! Finance]Yahoo! Finance
- Arcutis to Report First Quarter 2026 Financial Results and Host Conference Call on May 6, 2026GlobeNewswire
ARQT
Earnings
- 2/25/26 - Beat
ARQT
Sec Filings
- 4/21/26 - Form S-8
- 4/21/26 - Form ARS
- 4/21/26 - Form DEFA14A
- ARQT's page on the SEC website