Arcutis (ARQT) Announces Long-Term Phase 3 Data for ZORYVE Cream in Children

Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) is one of the best growth stocks to buy right now. On March 10, Arcutis Biotherapeutics announced the publication of long-term Phase 3 data regarding ZORYVE (roflumilast) cream 0.05% for children aged 2 to 5 with mild-to-moderate atopic dermatitis. The INTEGUMENT-OLE study, which followed patients for up to 52 weeks, showed that the once-daily nonsteroidal treatment is safe and well-tolerated, with efficacy that consistently improved over the course of the year.

These findings supported the FDA approval of the 0.05% strength in October 2025, providing a durable option for a pediatric population that often faces limited long-term therapy choices. The study results showed that 63.1% of children who completed 56 weeks of treatment achieved ‘Clear’ or ‘Almost Clear’ skin, and over 70% reached a 75% reduction in their Eczema Area and Severity Index score.

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A significant subset of participants who achieved total skin clearance were transitioned to a proactive twice-weekly maintenance regimen; these children sustained disease control for a median duration of ~8 months. Caregivers also reported substantial improvements in itch, with over 57% of patients showing a significant reduction in itch intensity by the study’s conclusion. Regarding safety, the treatment exhibited a favorable profile with most adverse events being mild to moderate, such as upper respiratory tract infections and nasopharyngitis.

Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) develops and commercializes treatments for dermatological diseases. Its lead product is a topical roflumilast cream for plaque psoriasis & atopic dermatitis, called ZORYVE.

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