Arcutis Biotherapeutics, Inc.

Arcutis Appoints Rob Scott, MD to Board of Directors

Arcutis Biotherapeutics appointed Rob Scott, MD, to its Board of Directors effective October 23, 2026. Scott is a former AbbVie Chief Medical Officer with over 40 years in drug development, tied to approvals including Skyrizi, Rinvoq, Venclexta, Repatha, and Lipitor, and served on the FDA Cardiac and Renal Drug Advisory Committee. The appointment adds deep regulatory and dermatology/immunology development expertise as Arcutis scales ZORYVE adoption and advances its pipeline, including new ZORYVE indications and a novel biologic.

•4d ago

Arcutis Presents ZORYVE® (roflumilast) Data and Real-World Topical Corticosteroid Research at EADV and Fall Clinical

Arcutis presented new ZORYVE data at the EADV Congress and Fall Clinical Dermatology Conference, including Phase 2 INTEGUMENT-INFANT results showing once-daily ZORYVE cream 0.05% was well tolerated in 101 infants with atopic dermatitis, with 34.4% achieving vIGA-AD success at 4 weeks. Phase 3 subanalyses showed ZORYVE foam 0.3% outperformed vehicle on scalp (66.4% vs 27.8%) and body (45.5% vs 20.1%) clearance at Week 8 in psoriasis, and ZORYVE cream and foam improved quality-of-life and sexual-function measures. ZORYVE cream 0.05% remains under FDA review for infants 3 to <24 months with a PDUFA target action date of February 23, 2027. Real-world research with patient groups highlighted topical corticosteroid hesitancy and adverse-event concerns, positioning steroid-free alternatives like ZORYVE favorably.

•23d ago

Simone Biles Partners with Arcutis to Launch the Skin to Believe In Campaign, Raising Awareness of Seborrheic Dermatitis and Eczema, and Inspiring People to Explore Treatment Options

Arcutis Biotherapeutics partnered with Olympic gymnast Simone Biles to launch the Skin to Believe In awareness campaign for seborrheic dermatitis and eczema. Biles discloses she uses ZORYVE foam and cream, and the release notes ZORYVE is the #1 prescribed branded topical therapy across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis combined. The campaign targets the roughly 36 million Americans with inflammatory skin conditions; it is a marketing catalyst for prescriptions rather than new clinical or financial news.

•1mo ago

Bloom Energy, Illumina, and Everpure Set to Join S&P 500; Others to Join S&P 100, S&P MidCap 400, and S&P SmallCap 600

AGNC Investment will be added to the S&P MidCap 400 effective prior to the open of trading on Monday, September 21, 2026, as part of S&P Dow Jones Indices' quarterly rebalance. The same reshuffle sends Bloom Energy, Illumina, and Everpure to the S&P 500, while The Trade Desk, Molson Coors Beverage, and Builders FirstSource drop from the S&P 500 to the S&P SmallCap 600. Funds benchmarked to the MidCap 400 will need to buy AGNC shares at the effective date, which can produce a short-lived mechanical bid rather than a fundamental re-rating.

•1mo ago

Arcutis Announces Second Quarter 2026 Financial Results and Provides Business Update

Arcutis reported Q2 net product revenue of $129.9 million, up 59% year-over-year, driven by strong demand for the ZORYVE franchise and improved pricing. The company achieved profitability with net income of $15.0 million, or $0.11 per share, and raised full-year 2026 sales guidance to $525 million–$540 million. Regulatory progress included an FDA approval expanding ZORYVE cream 0.3% to children aged two and up, while the board appointed Mirum Pharmaceuticals CEO Chris Peetz as a new director.

•2mo ago

Arcutis Expands Board of Directors with Appointment of Chris Peetz

Arcutis appointed Christopher Peetz to its Board of Directors effective July 15, 2026, adding a veteran executive with significant experience in biopharmaceutical growth and M&A. Peetz currently serves as CEO of Mirum Pharmaceuticals and previously led Tobira through its acquisition by Allergan, bringing expertise in commercialization and strategic scaling. The company expects his background to support the expansion of the ZORYVE franchise and the evaluation of external innovation opportunities.

•3mo ago

Attovia Therapeutics Appoints John W. Smither to Board of Directors

Attovia Therapeutics appointed John W. Smither to its Board of Directors as an independent director and Chair of the Audit Committee, effective immediately. Smither currently serves as CFO of MBX Biosciences and brings extensive financial leadership experience from roles at Arcutis Biotherapeutics and other biotech firms. Co-founder Yuling Luo, PhD, will step down from the Board, though the company noted he will continue to contribute through its partnership with Alamar Biosciences.

•3mo ago

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

The FDA accepted Arcutis' supplemental New Drug Application for ZORYVE cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3 to 24 months, setting a PDUFA target action date of February 23, 2027. The application is supported by positive Phase 2 data from the INTEGUMENT-INFANT study, where 34.4% of infants achieved vIGA-AD success and 58.3% achieved EASI-75 at week 4, with a safety profile consistent with older cohorts. This expansion targets a significant unmet need, as approximately 1 million children under the age of 2 are currently treated topically for atopic dermatitis in the United States.

•3mo ago

Arcutis Launches New Virtual Health Platform Supporting Access to Care for Individuals Living with Chronic Inflammatory Skin Diseases, Including Approved ZORYVE® (roflumilast) Indications

Arcutis launched a new virtual health platform to expand access to its ZORYVE portfolio for chronic inflammatory skin diseases like eczema and psoriasis. The digital offering connects patients with independent board-certified dermatologists, aiming to reduce barriers such as long wait times and geographic limitations. ZORYVE is currently the number one prescribed branded topical therapy across these three indications, having recently received strong recommendations from the American Academy of Dermatology.

•4mo ago

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

Arcutis received FDA approval for a supplemental indication of ZORYVE cream 0.3%, expanding its use to treat plaque psoriasis in children as young as 2 years of age. The approval is supported by data from a 4-week maximal usage systemic exposure study and an open-label extension study demonstrating safety and efficacy profiles consistent with pivotal trials in older patients. This is the seventh FDA approval for the ZORYVE portfolio in four years, establishing it as the first once-daily steroid-free topical therapy approved for this young patient population.

•4mo ago

Arcutis Announces First Quarter 2026 Financial Results and Provides Business Update

Arcutis reported Q1 2026 net product revenue of $105.4 million, up 65% year-over-year, driven by robust demand for ZORYVE despite typical Q1 seasonality. The company maintained positive operating cash flow of $2.2 million and affirmed full-year revenue guidance of $480 million to $495 million. Pipeline advancements include an sNDA submission for ZORYVE cream in infant atopic dermatitis and the initiation of a Phase 1 trial for ARQ-234.

•5mo ago

Arcutis’ ZORYVE® (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis Guidelines

Arcutis announced that ZORYVE (roflumilast) cream received a strong recommendation with high certainty of clinical evidence in the American Academy of Dermatology's first-ever pediatric atopic dermatitis guidelines. The guidelines recommend ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis. Atopic dermatitis affects approximately 9.6 million children in the United States, representing a significant patient population for this steroid-free topical PDE4 inhibitor.

•6mo ago