Zoryve is a topical roflumilast phosphodiesterase-4 inhibitor franchise with approved cream and foam formulations for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis in age-defined populations. Labeling includes multiple strengths and indicates topical use only. Initial U.S. approval in this label is 2011.
Arcutis is in focus after new Phase 3 extension data for Zoryve cream 0.05% in young children with atopic dermatitis and ahead of its Feb. 25 Q4 results. Investors are also watching recent FDA actions and pipeline updates for additional pediatric and dermatology indications.
The FDA has approved topical difamilast, a PDE4 inhibitor, for treating mild-to-moderate atopic dermatitis in adults and children aged 2 years or older, marking the third PDE4 inhibitor approval for this indication.
Arcutis Biotherapeutics is scheduled to report fourth-quarter and full-year 2025 results on Feb. 25, after market close. Investors will focus on sales performance of Zoryve and pipeline updates.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05763082 |
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis |
COMPLETED | PHASE3 |
