Arcutis Biotherapeutics, Inc.

Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company that develops and sells treatments for dermatological diseases with significant unmet medical needs. The company's portfolio includes topical and systemic treatments designed for immune-mediated dermatological diseases and conditions. Arcutis focuses on validated biological targets and uses its drug development platform and dermatology expertise to create differentiated products that aim to improve upon existing therapies. The company launched its primary product, ZORYVE cream 0.3%, in August 2022. This launch followed initial FDA approval for treating plaque psoriasis, including psoriasis in intertriginous areas, in individuals 12 years of age or older. ZORYVE cream 0.3% is a once-daily topical formulation of roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor. It is approved for once-daily topical treatment of mild, moderate, and severe plaque psoriasis without limitations on location or duration of use. In October 2023, the FDA approved an expanded indication for ZORYVE cream 0.3% for plaque psoriasis in individuals down to 6 years of age. In November 2025, the FDA accepted a supplemental New Drug Application (sNDA) to potentially expand ZORYVE cream 0.3%'s indication for plaque psoriasis in children down to 2 years of age, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. Arcutis expanded commercially outside the United States in June 2023, following Health Canada's approval of ZORYVE cream 0.3% for treating plaque psoriasis in individuals 12 years of age or older. In February 2026, Health Canada accepted a Supplement to a New Drug Submission (SNDS) for ZORYVE cream 0.3% for individuals down to 2 years old.