ARQT

FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027 Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study 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 atopic dermatitis WESTLAKE VILLAGE, Calif., July 08, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today 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.

WESTLAKE VILLAGE, Calif., July 02, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the grant of an aggregate of 61,000 restricted stock units (RSUs) of Arcutis common stock to 9 newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of July 1, 2026, as a material inducement to the new employees in connection with their commencement of employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

Virtual health platform offers an additional pathway to care for the more than 45 million people in the U.S. living with eczema, seborrheic dermatitis, and plaque psoriasis Connects eligible individuals with independent, board-certified dermatologists through a streamlined digital experience for evaluation and to discuss potential treatment options WESTLAKE VILLAGE, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of a new virtual health platform designed to expand access pathways to its ZORYVE® (roflumilast) portfolio for chronic inflammatory skin diseases.

ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for children with plaque psoriasis as young as 2 years of age ZORYVE cream 0.3% is safe, effective, and well-tolerated for use anywhere on the body with no restrictions on duration of use Seventh FDA approval for ZORYVE in four years WESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2.

Arcutis Biotherapeutics NASDAQ: ARQT executives said ZORYVE continues to post strong growth and outlined several regulatory and clinical catalysts expected over the next year, while emphasizing that the company has reached a self-sustaining financial position.

Arcutis Biotherapeutics, Inc. (ARQT) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

WESTLAKE VILLAGE, Calif., June 05, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 44,000 restricted stock units of Arcutis' common stock to six newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of June 1, 2026, as a material inducement to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

Expert recommendations focused on the diagnosis and management of genital psoriasis across age groups including pediatric, adult, and older populations This is the second published manuscript from the Genital Psoriasis Wellness Consortium, a multidisciplinary group of expert clinicians Genital involvement occurs in approximately two-thirds of the nine million individuals with plaque psoriasis in the United States WESTLAKE VILLAGE, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the publication of a new manuscript in the American Journal of Clinical Dermatology by the Genital Psoriasis Wellness Consortium.

Arcutis today announced that management will present at the Goldman Sachs 47th Annual Global Healthcare Conference, taking place June 8-10, 2026, in Miami.

Arcutis Biotherapeutics (ARQT) is evolving into a specialized dermatology platform, leveraging ZORYVE's expanding indications, formulations, and prescriber base for compounding revenue growth. ARQT reported Q1 2026 net revenues of $105.4M (up 65% YoY), reaffirmed 2026 revenue guidance of $480–495M, and demonstrated a significant reduction in net loss with strong gross margins. ZORYVE's pediatric and primary care expansion, new product launches, and pipeline progress support ARQT's strategy to capture a larger share of the chronic dermatology market.