Arcutis Biotherapeutics, Inc. will release its second quarter 2026 financial results after the U.S. financial markets close on Wednesday, August 5, 2026. The commercial-stage biopharmaceutical company, focused on immuno-dermatology, will also provide a business update during the announcement. A conference call and webcast are scheduled for 4:30 p.m. ET on the same day to discuss the results and corporate developments.

Investors and interested parties can access the live webcast and related presentation materials through the "Events" section of the Arcutis website. A replay of the webcast will be available on the company's investor relations website following the conclusion of the conference call.

Conference Call Details

Arcutis Biotherapeutics, Inc. is a commercial-stage medical dermatology company developing targeted topical treatments for chronic inflammatory skin diseases. The company's portfolio includes therapies approved for three major inflammatory skin conditions.

Arcutis Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. If approved, ZORYVE cream 0.05% would be the first once-daily advanced targeted topical treatment for this vulnerable patient population.

The sNDA is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study and a Phase 1 open-label pharmacokinetic (PK) study. Both studies evaluated once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and exploratory efficacy over 4 weeks, while the Phase 1 study enrolled 19 infants. The studies demonstrated PK, safety, and efficacy profiles consistent with prior studies in children 2 to 5 years of age.

Key Trial Results

The clinical trials demonstrated a well-tolerated safety profile with no new safety signals identified through 4 weeks of treatment. The most frequently reported adverse events included diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Caregivers reported rapid improvements in itch, with 46.6% of infants achieving at least a 25% improvement from baseline in pruritus within 10 minutes after application.

About Atopic Dermatitis and ZORYVE

Atopic dermatitis is the most common form of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Approximately 1 million children under the age of 2 are treated topically for atopic dermatitis in the United States, representing 10% of all adults and children treated topically for the condition. ZORYVE cream 0.05% is a once-daily, steroid-free, non-greasy topical treatment that does not contain sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. It is currently approved for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years.