(RTTNews) - Arcutis Biotherapeutics Inc. (ARQT), on Monday, announced that its phase 2 study evaluating ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis has yielded positive topline results.
In the phase 2 study, dubbed INTEGUMENT-INFANT, which enrolled 101 infants, 58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4. Moreover, the product was well tolerated and demonstrated a safety profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatment.
Zoryve cream, 0.05%, received FDA approval for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age as recently as last October.
The company expects to file a supplemental New Drug Application (sNDA) to extend the use of ZORYVE cream 0.05% to patients aged 3 months to less than 24 months next quarter (Q2 2026).
ARQT closed Friday's (Jan.30, 2026) trading at $25.37, down 1.40%.
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