Arcutis Biotherapeutics, Inc.（ARQT）资讯与事件ARQTArcutis Biotherapeutics, Inc.

Arcutis Presents Zoryve Data at EADV Congress

Arcutis Biotherapeutics announced data presented across its Zoryve portfolio as well as real-world research on the long-term use of topical corticosteroids at the 35th European Academy of Dermatology and Venereology, or EADV, Congress, held Sept. 30-Oct. 3 in Vienna, Austria, and the Fall Clinical Dermatology Conference, held Oct. 8-11 in Las Vegas, Nevada. Arcutis presented data from the Phase 2 INTEGUMENT-INFANT study of investigational once-daily Zoryve cream 0.05% in infants aged 3 to less than 24 months with atopic dermatitis. Zoryve cream 0.05% is approved for topical treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, and is under review by the FDA for the treatment of infants 3 to less than 24 months old with a Prescription Drug User Fee Act, or PDUFA, target action date of February 23, 2027. The company also presented two analyses of Zoryve foam 0.3% and Zoryve cream 0.3% in the treatment of plaque psoriasis in special sites, including the scalp and genitals, drawn from the Phase 3 ARRECTOR and DERMIS-1/2 trials. In addition, collaborators at Mount Sinai presented new findings underscoring the inflammatory pathway of seborrheic dermatitis, its unique cutaneous molecular signature, and barrier impairment via proteomics measured on both tape strips and skin biopsies. In this Phase 2 study, investigational once-daily Zoryve cream 0.05% was well tolerated in 101 infants with atopic dermatitis, with no serious adverse events and no evidence of application-site irritation for at least 97.9% of infants. Zoryve cream 0.05% demonstrated rapid disease clearance through 4 weeks of treatment. Among infants who completed 4 weeks of treatment in INTEGUMENT-INFANT, 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis Success, defined as a score of 0 or 1 with a greater than or equal to 2-grade improvement from baseline. Additionally, IGA-Scalp Success, defined as a score of 0 or 1 with a greater than or equal to 2-grade improvement from baseline, was achieved by 67.5% of infants. Caregivers also reported rapid itch improvement, with 46.6% of infants achieving at least a 25% improvement in pruritus from baseline within 10 minutes of application, as assessed by caregivers, based on the Dynamic Pruritus Scale. In a subanalysis of the Phase 3 trial of 432 patients aged 12 and older, more patients treated with Zoryve foam 0.3% than vehicle foam achieved clear or almost clear skin at Week 8 on both the scalp and the body. Within 24 hours of the first application, individuals treated with Zoryve experienced greater improvement in mean itch scores compared to vehicle. This analysis of patients from the DERMIS-1/2 and ARRECTOR studies found that Zoryve cream 0.3% and foam 0.3% improved psoriasis signs and symptoms and quality of life, along with patient-reported sexual function and personal relationships, through Week 8, in individuals with psoriasis both with and without genital involvement at baseline. Using proteomic analysis of tape strips and skin biopsies from adults with seborrheic dermatitis, this collaborative research identified the inflammatory pathways driving the disease and the skin barrier impairment that distinguishes it from atopic dermatitis, while also highlighting seborrheic dermatitis as a primarily Th17-mediated disease.

Arcutis Partners with Simone Biles for Skin Health Campaign

Arcutis Biotherapeutics announced that World Champion gymnast Simone Biles has partnered with the company to launch its Skin to Believe In awareness campaign. The campaign encourages the approximately 36M Americans living with inflammatory skin conditions to talk with their doctor about long-term, steroid-free, topical treatment options for their chronic skin diseases.

Arcutis Biotherapeutics Shares Down 5.1%

Arcutis Biotherapeutics is down -5.1%, or -$1.33 to $24.81.