Arcutis reports 34.4% infant skin clearance

• Arcutis Biotherapeutics (NASDAQ:ARQT) reported Phase 2 ZORYVE data showing 34.4% of infants achieved clear or almost clear skin after four weeks.
• Phase 3 psoriasis data showed ZORYVE foam 0.3% achieved clear or almost clear skin more often than vehicle on both scalp and body.
• The infant atopic dermatitis indication remains under FDA review, with a February 23, 2027 target action date.

Arcutis Biotherapeutics (NASDAQ:ARQT) presented new ZORYVE clinical data in infants with atopic dermatitis and patients with psoriasis at EADV and Fall Clinical.

In the Phase 2 INTEGUMENT-INFANT study, 34.4% of 96 infants completing four weeks achieved clear or almost clear skin with at least a two-grade improvement.

Among 101 treated infants, no serious adverse events were reported, while at least 97.9% showed no application-site irritation.

The proposed infant indication for ZORYVE cream 0.05% remains under FDA review, with a target action date of February 23, 2027.

In the Phase 3 ARRECTOR analysis, ZORYVE foam 0.3% achieved clear or almost clear skin at Week 8 in 66.4% of scalp assessments versus 27.8% with vehicle, and 45.5% versus 20.1% on the body.

Additional ARRECTOR analyses reported improvements in sexual function and personal relationships through Week 8 among patients with psoriasis.

Arcutis also presented collaborative research on seborrheic dermatitis biology and survey findings examining long-term use of topical corticosteroids.