Arcutis Reports Positive Phase 2 Data For ZORYVE Cream 0.05% In Infants With Atopic Dermatitis

Core Insights - Arcutis Biotherapeutics Inc. announced positive topline results from its phase 2 study of ZORYVE cream 0.05% for treating atopic dermatitis in infants aged 3 months to less than 24 months [1] Group 1: Study Results - The phase 2 study, named INTEGUMENT-INFANT, involved 101 infants, with 58% of participants achieving a 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 4 [2] - ZORYVE cream 0.05% was well tolerated, showing a safety profile consistent with previous studies, and no new safety signals were identified during the 4-week treatment period [2] Group 2: Regulatory and Market Information - The company plans to file a supplemental New Drug Application (sNDA) to extend the use of ZORYVE cream 0.05% to the target age group in Q2 2026 [4] - As of January 30, 2026, Arcutis Biotherapeutics Inc. shares closed at $25.37, reflecting a decrease of 1.40% [4]