ARQT News & Events

Arcutis Biotherapeutics announced new data from the Integument-Infant Phase 2 trial demonstrating that Zoryve cream 0.05% reduced signs and symptoms of atopic dermatitis, the most common form of eczema, in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. These results build upon the topline results announced last month and further support the potential of investigational Zoryve cream as a treatment option for this youngest and very vulnerable population. The results were presented today during a late-breaking podium presentation at the 2026 American Academy of Dermatology, AAD, Annual Meeting in Denver, CO.

Arcutis Biotherapeutics will present new data from its clinical development program and marketed ZORYVE portfolio during the 2026 American Academy of Dermatology Annual Meeting taking place March 27-31 in Denver. In an AAD late-breaking podium presentation, the Company will share new efficacy, safety, and tolerability results from its INTEGUMENT-INFANT Phase 2 trial evaluating investigational once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis, building on recently announced topline data. In addition, a five-minute poster presentation will highlight long-term caregiver-reported outcomes from its INTEGUMENT-OLE Phase 3 trial of ZORYVE cream 0.05% in children aged 2 to 5 years with mild to moderate atopic dermatitis. Additional results will be presented in two e-posters from a STRATUM Phase 3 trial subgroup analysis in individuals with seborrheic dermatitis with face and scalp involvement, and Psoriasis Area and Severity Index outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR trials in individuals with plaque psoriasis. "This year's AAD presentations reflect the continued momentum of our clinical development program and the expanding body of evidence supporting the value of ZORYVE across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis," said Patrick Burnett, CMO. "We are particularly excited to share new results from the INTEGUMENT-INFANT trial evaluating investigational ZORYVE cream 0.05% in infants with mild to moderate atopic dermatitis, with its inclusion as a late-breaking session underscoring the need for additional therapeutic options for this underserved pediatric age group."

Arcutis Biotherapeutics announced that Pediatric Dermatology published data from the Phase 3 open-label extension study evaluating once-daily Zoryve cream 0.05% in children aged 2 to 5 years with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of Zoryve cream 0.05% in October 2025, demonstrated that Zoryve cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment. The primary endpoint of the OLE study was safety. Treatment-Emergent Adverse Events were reported for 280 participants, and most events were mild or moderate. The most common TEAEs included upper respiratory tract infection in 8.7% of participants, nasopharyngitis in 5.0%, and pyrexia in 5.0%. Gastrointestinal adverse events were reported for 4.4% of participants, most commonly vomiting and diarrhea. Serious Adverse Events occurred in 18 participants, none of which were considered treatment-related. Overall, 14 of 562 participants experienced treatment-related AEs, and 4 participants experienced application site pain.

Arcutis Biotherapeutics announced the promotion of Mas Matsuda, JD, currently senior vice president and general counsel, to executive vice president, chief legal officer, and corporate secretary. Matsuda will continue to lead the Company's legal, compliance, and governance strategy in support of the continued growth of the Company, commercialization of the ZORYVE portfolio, and protection of the Company's intellectual property, as well as any corporate transactions.