{"success":true,"data":{"pressRelease":{"id":"165350","rtpr_id":"nGNX4CfWfD-20261009","ticker":"ARQT","exchange":"NASDAQ","all_tickers":["ARQT"],"title":"Arcutis Presents ZORYVE® (roflumilast) Data and Real-World Topical Corticosteroid Research at EADV and Fall Clinical","author":"Globe Newswire","published_at":"2026-10-09T12:00:00.821Z","article_body":"* Presentation of data from the INTEGUMENT-INFANT trial of investigational\nZORYVE cream 0.05% in infants ages 3 to <24 months, where treatment options\nremain limited\n* New analyses from the ARRECTOR and DERMIS-1/2 trials further demonstrate\nZORYVE's efficacy and symptom improvements across the body in individuals with\npsoriasis\n* Additional data from collaborative research reinforce the inflammatory\npathway and barrier impairment involved in seborrheic dermatitis\n* Real-world research examines the role long-term topical corticosteroid use\nplays in the care of adults and children with chronic inflammatory skin\nconditions\nWESTLAKE VILLAGE, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Arcutis\nBiotherapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=sypr9PSQpuj2Jr9A5QK43uEz_roOmotDycjVqamEsNlqlSaHGpXpAmM8CWnHcopo8pwpV0dbUsVUxR9yHBBjGxkJ7-LTkhm2D60sDQhmH3I=) (Nasdaq:\nARQT), a commercial-stage biopharmaceutical company focused on developing\nmeaningful innovations in immuno-dermatology, today announced data presented\nacross its ZORYVE(®) (roflumilast) portfolio as well as real-world research\non the long-term use of topical corticosteroids at the 35(th) European Academy\nof Dermatology and Venereology (EADV) Congress, held Sept. 30-Oct. 3 in\nVienna, Austria, and the Fall Clinical Dermatology Conference, held Oct. 8-11\nin Las Vegas, Nevada.\n\n“The data presented at these two meetings add to the growing body of\nevidence supporting ZORYVE across three chronic inflammatory skin conditions\nand a wide range of ages, including infants, the most vulnerable and\nunderserved patient populations. The results include positive data for\nonce-daily ZORYVE cream in infants ages 3 to 24 months with atopic dermatitis,\nand ZORYVE cream and foam in people with psoriasis, including genital\ninvolvement and the impact of disease on sexual function and personal\nrelationships,” said Frank Watanabe, president and chief executive officer\nof Arcutis. “We also shared new collaborative research on the\npathophysiology of seborrheic dermatitis that further characterizes the\ncutaneous molecular signature of the disease.”\n\nZORYVE (roflumilast) data and research advancing disease insights: \nArcutis presented data from the Phase 2 INTEGUMENT-INFANT study of\ninvestigational once-daily ZORYVE cream 0.05% in infants aged 3 to less than\n24 months with atopic dermatitis. ZORYVE cream 0.05% is approved for topical\ntreatment of mild to moderate atopic dermatitis in children aged 2 to 5 years,\nand is under review by the U.S. Food and Drug Administration (FDA) for the\ntreatment of infants 3 to less than 24 months old with a Prescription Drug\nUser Fee Act (PDUFA) target action date of February 23, 2027. The company also\npresented two analyses of ZORYVE foam 0.3% and ZORYVE cream 0.3% in the\ntreatment of plaque psoriasis in special sites, including the scalp and\ngenitals, drawn from the Phase 3 ARRECTOR and DERMIS-1/2 trials. In addition,\ncollaborators at Mount Sinai presented new findings underscoring the\ninflammatory pathway of seborrheic dermatitis, its unique cutaneous molecular\nsignature, and barrier impairment via proteomics measured on both tape strips\nand skin biopsies.\n* INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3 to\n<24 Months With Atopic Dermatitis. \nL. Eichenfield, et al. \nEADV Congress, Poster P2401.\nIn this Phase 2 study, investigational once-daily ZORYVE cream 0.05% was well\ntolerated in 101 infants with atopic dermatitis, with no serious adverse\nevents and no evidence of application-site irritation for at least 97.9% of\ninfants. ZORYVE cream 0.05% demonstrated rapid disease clearance through 4\nweeks of treatment. Among infants who completed 4 weeks of treatment in\nINTEGUMENT-INFANT (n=96), 34.4% achieved Validated Investigator Global\nAssessment for Atopic Dermatitis (vIGA-AD) Success, defined as a score of 0\n(Clear) or 1 (Almost Clear) with a ≥2-grade improvement from baseline.\nAdditionally, IGA-Scalp Success, defined as a score of 0 (Clear) or 1 (Almost\nClear) with a ≥2-grade improvement from baseline, was achieved by 67.5% of\ninfants. Caregivers also reported rapid itch improvement, with 46.6% of\ninfants achieving at least a 25% improvement in pruritus (itch) from baseline\nwithin 10 minutes of application, as assessed by caregivers, based on the\nDynamic Pruritus Scale (DPS-25) (n=88).\n* Pattern of Improvement in Scalp Versus Body Psoriasis With Roflumilast Foam\n0.3%: An Analysis of the Phase 3 ARRECTOR Trial. \nM. Gooderham, et al. \nFall Clinical Dermatology Conference.\nIn a subanalysis of the Phase 3 trial of 432 patients aged 12 and older, more\npatients treated with ZORYVE foam 0.3% than vehicle foam achieved clear or\nalmost clear skin at Week 8 on both the scalp (66.4% vs 27.8%) and the body\n(45.5% vs 20.1%). Within 24 hours of the first application, individuals\ntreated with ZORYVE experienced greater improvement in mean itch scores\ncompared to vehicle (SI-NRS, defined as a patient-reported measure of scalp\nitch severity: Least-squares mean improvement of 0.44 vs 0.09; WI-NRS, defined\nas a patient-reported measure of worst itch severity: Least-squares mean\nimprovement of 0.42 vs 0.01).\n* Improvements in Psoriasis, Including Sexual Function and Personal\nRelationships, With Roflumilast Cream 0.3% and Foam 0.3%: Outcomes From the\nPhase 3 DERMIS-1/2 and ARRECTOR Trials. \nM. Payette, et al. \nFall Clinical Dermatology Conference.\nThis analysis of patients from the DERMIS-1/2 and ARRECTOR studies found that\nZORYVE cream 0.3% and foam 0.3% improved psoriasis signs and symptoms and\nquality of life, along with patient-reported sexual function and personal\nrelationships, through Week 8, in individuals with psoriasis both with and\nwithout genital involvement at baseline.\n* Tape-strip Proteomic Profiling and Biopsy Validation Highlight Inflammatory\nPathogenesis in Seborrheic Dermatitis.\nE. Guttman, et al.\nEADV Congress, Poster P2290.\nUsing proteomic analysis of tape strips and skin biopsies from adults with\nseborrheic dermatitis, this collaborative research identified the inflammatory\npathways driving the disease and the skin barrier impairment that\ndistinguishes it from atopic dermatitis, while also highlighting seborrheic\ndermatitis as a primarily Th17-mediated disease.\nReal-world topical corticosteroid research:\nArcutis will present for the first time real-world survey research developed\nin collaboration with the National Eczema Association and the National\nPsoriasis Foundation, alongside a new targeted review of published literature\non adverse events associated with topical corticosteroid use.\n* Real-World Topical Corticosteroid Treatment Patterns and Perceptions of\nDisease Control Among Adults and Caregivers of Children With Atopic\nDermatitis, Psoriasis, or Seborrheic Dermatitis. \nE. Simpson, et al. \nFall Clinical Dermatology Conference.\nIn a survey of 1,000 adults and 500 caregivers of children prescribed topical\ncorticosteroids for plaque psoriasis, atopic dermatitis, and seborrheic\ndermatitis, most agreed their treatment focused on reacting to flares rather\nthan long-term control (78.8% of adults, 77.6% of caregivers). About a third\nexperienced uncontrolled symptoms at least weekly (36.1% adults; 32.8%\nchildren). Furthermore, even when symptoms were controlled, more than half of\nadults (56.7%) and caregivers (54.8%) reported anxiety over symptoms becoming\nuncontrolled, which was greater for patients prescribed more than one\ncorticosteroid.\n* Real-World Long-Term Topical Corticosteroid Use and Adverse Event Concerns\nAmong Adults and Caregivers of Children With Atopic Dermatitis, Psoriasis, or\nSeborrheic Dermatitis. \nT. Bhutani, et al. \nFall Clinical Dermatology Conference.\nA companion analysis of the same survey described above found that many\nrespondents did not use topical corticosteroids as prescribed, often citing\nconcerns about skin thinning and long-term side effects. Nearly half hesitated\nto raise concerns about long-term steroid use with their provider (47.8% of\nadults, 45.0% of caregivers). Furthermore, corticosteroid hesitancy was\nsignificantly associated with prior treatment experience: Hesitancy was higher\namong individuals who had ever experienced a negative reaction to a\ncorticosteroid vs. those who had not (adults: 61.6% vs 34.7%; children: 57.0%\nvs 34.6%) and among those prescribed more than one corticosteroid vs. one\ncorticosteroid (adults: 56.1% vs 43.8%; children: 53.9% vs 38.2%).\n* Cutaneous and Systemic Adverse Events Associated With Topical Corticosteroid\nUse: A Targeted Literature Review. \nA. Golant, et al. \nEADV Congress, Poster P2706.\nThis review of literature published between August 2015 and September 2025\nidentified 42 case reports and series describing cutaneous and systemic\nadverse events in 83 patients treated with topical corticosteroids. Skin\neffects such as atrophy and striae appeared in 69.0% of publications, and the\nmost common systemic side effects were Cushing’s syndrome or features\n(47.6%) and HPA axis suppression/adrenal insufficiency (40.5%). The authors\npoint to a need for improved prescribing practices, ongoing monitoring of\nadverse events and documentation of cumulative steroid exposure, highlighting\na role for alternative therapies that control chronic disease without the\nlimitations of steroids.\n“This growing body of research deepens our understanding of what long-term\ntopical corticosteroid use means for people living with chronic inflammatory\nskin conditions,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer\nof Arcutis. “This includes findings from a real-world survey, presented at\na medical congress for the first time, alongside a targeted review of the\nliterature examining adverse events associated with topical corticosteroid\nuse. Together, these data provide important context on treatment patterns,\nperceptions of disease control, and patient and caregiver concerns around\nlong-term use, helping to inform continued discussions around responsible and\nappropriate topical corticosteroid use and steroid stewardship in the\nmanagement of chronic inflammatory skin diseases.”\n\nAbout ZORYVE(®) (roflumilast) \nZORYVE is the number one prescribed branded topical therapy across three major\ninflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis,\nand plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an\nadvanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor.\nInhibiting PDE4, an intracellular enzyme that is an established target in\ndermatology, decreases the production of pro-inflammatory mediators. This\ndecreases inflammation in the skin and balances the skin’s immune system.\n\nDemonstrating both clinical impact and broad industry recognition, ZORYVE has\nbeen honored with multiple prestigious awards, including three from major\nbeauty magazines:\n* Allure’s “2025 Best of Beauty Breakthrough Award,” making it the first\nFDA-approved medication for atopic dermatitis, plaque psoriasis, and\nseborrheic dermatitis to win this prominent award;\n* Glamour’s 2024 Beauty and Wellness Award for “Best Eczema Product,”\nrecognizing ZORYVE cream 0.15%;\n* And most recently, Marie Claire’s “2026 Best Prescription Skin\nSolution” Award, recognizing ZORYVE cream 0.15% for eczema.\nIn addition, ZORYVE has been honored with the following recommendations:\n* National Psoriasis Foundation’s Seal of Recognition for ZORYVE cream 0.3%\nand ZORYVE foam 0.3% — the first FDA-approved prescription brand to receive\nthe honor. \n* American Academy of Dermatology (AAD) issued a strong recommendation for the\nuse of ZORYVE cream 0.15% in adults with mild to moderate atopic dermatitis,\nin updated guidelines released June 2025, as well as a strong recommendation\nfor the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream\n0.15% for children aged 6 years and older with mild to moderate atopic\ndermatitis from the AAD’s first-ever pediatric atopic dermatitis guidelines\npublished in April 2026.\nINDICATIONS\nZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate\natopic dermatitis in pediatric patients 2 to 5 years of age.\n\nZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate\natopic dermatitis in adult and pediatric patients 6 years of age and older.\n\nZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis,\nincluding intertriginous areas, in adult and pediatric patients 2 years of age\nand older.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis\nof the scalp and body in adult and pediatric patients 12 years of age and\nolder.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic\ndermatitis in adult and pediatric patients 9 years of age and older.\n\nIMPORTANT SAFETY INFORMATION \nZORYVE is contraindicated in patients with moderate to severe liver impairment\n(Child-Pugh B or C).\n\nFlammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame,\nand smoking during and immediately following application.\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for\npediatric patients with atopic dermatitis 2 to 5 years of age were upper\nrespiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis\n(1.6%), conjunctivitis (1.4%), and headache (1.1%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for\npatients with atopic dermatitis 6 years of age or older were headache (2.9%),\nnausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting\n(1.5%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for\nplaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%),\nnausea (1.2%), application site pain (1.0%), upper respiratory tract infection\n(1.0%), and urinary tract infection (1.0%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nplaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and\nnasopharyngitis (1.3%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nseborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache\n(1.1%).\n\nPlease see full Prescribing Information for ZORYVE foam\n(https://www.globenewswire.com/Tracker?data=mm4vzl6TgH9rCEG8vt_dju9GD26VK02fDsTb4bJa-Yijjs9BAJXIyKVDSY03KDG4aGtc3n-PRxlKoDXYn1SoA20OOScnYaoScm1hP6KUEKvnW7SyAl_wZq3Vcb6mA0QtOuMGE_LuCcjP4pyLRdk0wg==)\nand full Prescribing Information for ZORYVE cream\n(https://www.globenewswire.com/Tracker?data=mm4vzl6TgH9rCEG8vt_dju9GD26VK02fDsTb4bJa-Yijjs9BAJXIyKVDSY03KDG4tkjYdcJjo38DI0gdYX3TvR4t2pdOc3qoQeZYp-PCZXv3BKeMks_Alu17isiBBdTp9LMT5enhe8iHv67aOkG4Qg==).\n\nAbout Arcutis\nArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical\ndermatology company delivering meaningful innovation to address the needs of\nindividuals living with chronic inflammatory skin diseases. Over the\npast decade, Arcutis has successfully developed a robust portfolio of\nadvanced targeted topicals approved to treat three major inflammatory skin\ndiseases, driven by a commitment to solving the most persistent patient\nchallenges in dermatology. Arcutis’ unique dermatology development\nplatform, built on established scientific pathways and coupled with deep\nclinical dermatology and commercial expertise, enables us to efficiently\ndevelop, scale, and deliver our differentiated therapies while advancing a\ngrowing pipeline across a range of inflammatory dermatological conditions.\nFor more information, visit www.arcutis.com or follow Arcutis on LinkedIn\n(https://www.globenewswire.com/Tracker?data=5ngQYef9hy4raOFwyCZPrfZONVFOvssj5kptP6XXiln3EvsivZ6wuGGe-r3G-W_PZ5JD-VuwxmTP7sCuvvWQVa1TkF7gY83RgMbYPQ423X07Tu2zCIjmeYlzVIVYdpRX), Facebook\n(https://www.globenewswire.com/Tracker?data=JVr3Yjkat8491qLjARnlONDTJaUosHqOvPds4rJ82bH8FtpN5nba0_5GX26jHiPNrS71HznIsFo8Mc5dA9XFBph-3q6p09f7kyYBsXxDnpQ=), Instagram\n(https://www.globenewswire.com/Tracker?data=zdmJvptIPgfvpvqCYQPzqxr8aBPu9clHhun607mpXKhyyqHRdFQjlyEIRSZ86gb4oiKr2J0sABhwIJIVArJrMNnAu8XKnXt72zov3duvjzM=),\nand X\n(https://www.globenewswire.com/Tracker?data=KhMf1gtFIaEdGoeDi0dC45n6uShL60LPfobLESfAQeIUCYKk40ozncXBRUmCwOY0EcPzUBqAf4AqWHwggPP15Q==). \n\nForward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended. For example, statements contained\nin this press release regarding matters that are not historical facts are\nforward-looking statements. These statements are based on the Company’s\ncurrent beliefs and expectations. Such forward-looking statements include, but\nare not limited to, statements regarding the potential FDA approval of ZORYVE\ncream 0.05% in infants 3 to 24 months, clinical trial and research results\ntranslating into real world results, and the potential for ZORYVE cream and\nZORYVE foam to advance the standard of care in atopic dermatitis, plaque\npsoriasis, and seborrheic dermatitis. These statements are subject to\nsubstantial known and unknown risks, uncertainties, and other factors that may\ncause our actual results, levels of activity, performance, or achievements to\nbe materially different from the information expressed or implied by these\nforward-looking statements. Risks and uncertainties that may cause our actual\nresults to differ include risks inherent in our business, reimbursement and\naccess to our products, the impact of competition and other important factors\ndiscussed in the “Risk Factors” section of our Form 10-K filed with the\nU.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as\nany subsequent filings with the SEC. Any forward-looking statements that the\nCompany makes in this press release are made pursuant to the Private\nSecurities Litigation Reform Act of 1995, as amended, and speak only as of the\ndate of this press release. Except as required by law, we undertake no\nobligation to revise or update information herein to reflect events or\ncircumstances in the future, even if new information becomes available.\n\nContacts:\nMedia\nAmanda Sheldon, Head of Corporate Communications\nmedia@arcutis.com\n\nInvestors\nBrian Schoelkopf, Head of Investor Relations\nir@arcutis.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1b166f47-afb1-44f1-91be-2d73e97c0ec3)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4CfWfD-20261009","title":"Arcutis Presents ZORYVE® (roflumilast) Data and Real-World Topical Corticosteroid Research at EADV and Fall Clinical","author":"Globe Newswire","ticker":"ARQT","created":"2026-10-09T12:00:00.821Z","tickers":["ARQT"],"exchange":"NASDAQ","article_body":"* Presentation of data from the INTEGUMENT-INFANT trial of investigational\nZORYVE cream 0.05% in infants ages 3 to <24 months, where treatment options\nremain limited\n* New analyses from the ARRECTOR and DERMIS-1/2 trials further demonstrate\nZORYVE's efficacy and symptom improvements across the body in individuals with\npsoriasis\n* Additional data from collaborative research reinforce the inflammatory\npathway and barrier impairment involved in seborrheic dermatitis\n* Real-world research examines the role long-term topical corticosteroid use\nplays in the care of adults and children with chronic inflammatory skin\nconditions\nWESTLAKE VILLAGE, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Arcutis\nBiotherapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=sypr9PSQpuj2Jr9A5QK43uEz_roOmotDycjVqamEsNlqlSaHGpXpAmM8CWnHcopo8pwpV0dbUsVUxR9yHBBjGxkJ7-LTkhm2D60sDQhmH3I=) (Nasdaq:\nARQT), a commercial-stage biopharmaceutical company focused on developing\nmeaningful innovations in immuno-dermatology, today announced data presented\nacross its ZORYVE(®) (roflumilast) portfolio as well as real-world research\non the long-term use of topical corticosteroids at the 35(th) European Academy\nof Dermatology and Venereology (EADV) Congress, held Sept. 30-Oct. 3 in\nVienna, Austria, and the Fall Clinical Dermatology Conference, held Oct. 8-11\nin Las Vegas, Nevada.\n\n“The data presented at these two meetings add to the growing body of\nevidence supporting ZORYVE across three chronic inflammatory skin conditions\nand a wide range of ages, including infants, the most vulnerable and\nunderserved patient populations. The results include positive data for\nonce-daily ZORYVE cream in infants ages 3 to 24 months with atopic dermatitis,\nand ZORYVE cream and foam in people with psoriasis, including genital\ninvolvement and the impact of disease on sexual function and personal\nrelationships,” said Frank Watanabe, president and chief executive officer\nof Arcutis. “We also shared new collaborative research on the\npathophysiology of seborrheic dermatitis that further characterizes the\ncutaneous molecular signature of the disease.”\n\nZORYVE (roflumilast) data and research advancing disease insights: \nArcutis presented data from the Phase 2 INTEGUMENT-INFANT study of\ninvestigational once-daily ZORYVE cream 0.05% in infants aged 3 to less than\n24 months with atopic dermatitis. ZORYVE cream 0.05% is approved for topical\ntreatment of mild to moderate atopic dermatitis in children aged 2 to 5 years,\nand is under review by the U.S. Food and Drug Administration (FDA) for the\ntreatment of infants 3 to less than 24 months old with a Prescription Drug\nUser Fee Act (PDUFA) target action date of February 23, 2027. The company also\npresented two analyses of ZORYVE foam 0.3% and ZORYVE cream 0.3% in the\ntreatment of plaque psoriasis in special sites, including the scalp and\ngenitals, drawn from the Phase 3 ARRECTOR and DERMIS-1/2 trials. In addition,\ncollaborators at Mount Sinai presented new findings underscoring the\ninflammatory pathway of seborrheic dermatitis, its unique cutaneous molecular\nsignature, and barrier impairment via proteomics measured on both tape strips\nand skin biopsies.\n* INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3 to\n<24 Months With Atopic Dermatitis. \nL. Eichenfield, et al. \nEADV Congress, Poster P2401.\nIn this Phase 2 study, investigational once-daily ZORYVE cream 0.05% was well\ntolerated in 101 infants with atopic dermatitis, with no serious adverse\nevents and no evidence of application-site irritation for at least 97.9% of\ninfants. ZORYVE cream 0.05% demonstrated rapid disease clearance through 4\nweeks of treatment. Among infants who completed 4 weeks of treatment in\nINTEGUMENT-INFANT (n=96), 34.4% achieved Validated Investigator Global\nAssessment for Atopic Dermatitis (vIGA-AD) Success, defined as a score of 0\n(Clear) or 1 (Almost Clear) with a ≥2-grade improvement from baseline.\nAdditionally, IGA-Scalp Success, defined as a score of 0 (Clear) or 1 (Almost\nClear) with a ≥2-grade improvement from baseline, was achieved by 67.5% of\ninfants. Caregivers also reported rapid itch improvement, with 46.6% of\ninfants achieving at least a 25% improvement in pruritus (itch) from baseline\nwithin 10 minutes of application, as assessed by caregivers, based on the\nDynamic Pruritus Scale (DPS-25) (n=88).\n* Pattern of Improvement in Scalp Versus Body Psoriasis With Roflumilast Foam\n0.3%: An Analysis of the Phase 3 ARRECTOR Trial. \nM. Gooderham, et al. \nFall Clinical Dermatology Conference.\nIn a subanalysis of the Phase 3 trial of 432 patients aged 12 and older, more\npatients treated with ZORYVE foam 0.3% than vehicle foam achieved clear or\nalmost clear skin at Week 8 on both the scalp (66.4% vs 27.8%) and the body\n(45.5% vs 20.1%). Within 24 hours of the first application, individuals\ntreated with ZORYVE experienced greater improvement in mean itch scores\ncompared to vehicle (SI-NRS, defined as a patient-reported measure of scalp\nitch severity: Least-squares mean improvement of 0.44 vs 0.09; WI-NRS, defined\nas a patient-reported measure of worst itch severity: Least-squares mean\nimprovement of 0.42 vs 0.01).\n* Improvements in Psoriasis, Including Sexual Function and Personal\nRelationships, With Roflumilast Cream 0.3% and Foam 0.3%: Outcomes From the\nPhase 3 DERMIS-1/2 and ARRECTOR Trials. \nM. Payette, et al. \nFall Clinical Dermatology Conference.\nThis analysis of patients from the DERMIS-1/2 and ARRECTOR studies found that\nZORYVE cream 0.3% and foam 0.3% improved psoriasis signs and symptoms and\nquality of life, along with patient-reported sexual function and personal\nrelationships, through Week 8, in individuals with psoriasis both with and\nwithout genital involvement at baseline.\n* Tape-strip Proteomic Profiling and Biopsy Validation Highlight Inflammatory\nPathogenesis in Seborrheic Dermatitis.\nE. Guttman, et al.\nEADV Congress, Poster P2290.\nUsing proteomic analysis of tape strips and skin biopsies from adults with\nseborrheic dermatitis, this collaborative research identified the inflammatory\npathways driving the disease and the skin barrier impairment that\ndistinguishes it from atopic dermatitis, while also highlighting seborrheic\ndermatitis as a primarily Th17-mediated disease.\nReal-world topical corticosteroid research:\nArcutis will present for the first time real-world survey research developed\nin collaboration with the National Eczema Association and the National\nPsoriasis Foundation, alongside a new targeted review of published literature\non adverse events associated with topical corticosteroid use.\n* Real-World Topical Corticosteroid Treatment Patterns and Perceptions of\nDisease Control Among Adults and Caregivers of Children With Atopic\nDermatitis, Psoriasis, or Seborrheic Dermatitis. \nE. Simpson, et al. \nFall Clinical Dermatology Conference.\nIn a survey of 1,000 adults and 500 caregivers of children prescribed topical\ncorticosteroids for plaque psoriasis, atopic dermatitis, and seborrheic\ndermatitis, most agreed their treatment focused on reacting to flares rather\nthan long-term control (78.8% of adults, 77.6% of caregivers). About a third\nexperienced uncontrolled symptoms at least weekly (36.1% adults; 32.8%\nchildren). Furthermore, even when symptoms were controlled, more than half of\nadults (56.7%) and caregivers (54.8%) reported anxiety over symptoms becoming\nuncontrolled, which was greater for patients prescribed more than one\ncorticosteroid.\n* Real-World Long-Term Topical Corticosteroid Use and Adverse Event Concerns\nAmong Adults and Caregivers of Children With Atopic Dermatitis, Psoriasis, or\nSeborrheic Dermatitis. \nT. Bhutani, et al. \nFall Clinical Dermatology Conference.\nA companion analysis of the same survey described above found that many\nrespondents did not use topical corticosteroids as prescribed, often citing\nconcerns about skin thinning and long-term side effects. Nearly half hesitated\nto raise concerns about long-term steroid use with their provider (47.8% of\nadults, 45.0% of caregivers). Furthermore, corticosteroid hesitancy was\nsignificantly associated with prior treatment experience: Hesitancy was higher\namong individuals who had ever experienced a negative reaction to a\ncorticosteroid vs. those who had not (adults: 61.6% vs 34.7%; children: 57.0%\nvs 34.6%) and among those prescribed more than one corticosteroid vs. one\ncorticosteroid (adults: 56.1% vs 43.8%; children: 53.9% vs 38.2%).\n* Cutaneous and Systemic Adverse Events Associated With Topical Corticosteroid\nUse: A Targeted Literature Review. \nA. Golant, et al. \nEADV Congress, Poster P2706.\nThis review of literature published between August 2015 and September 2025\nidentified 42 case reports and series describing cutaneous and systemic\nadverse events in 83 patients treated with topical corticosteroids. Skin\neffects such as atrophy and striae appeared in 69.0% of publications, and the\nmost common systemic side effects were Cushing’s syndrome or features\n(47.6%) and HPA axis suppression/adrenal insufficiency (40.5%). The authors\npoint to a need for improved prescribing practices, ongoing monitoring of\nadverse events and documentation of cumulative steroid exposure, highlighting\na role for alternative therapies that control chronic disease without the\nlimitations of steroids.\n“This growing body of research deepens our understanding of what long-term\ntopical corticosteroid use means for people living with chronic inflammatory\nskin conditions,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer\nof Arcutis. “This includes findings from a real-world survey, presented at\na medical congress for the first time, alongside a targeted review of the\nliterature examining adverse events associated with topical corticosteroid\nuse. Together, these data provide important context on treatment patterns,\nperceptions of disease control, and patient and caregiver concerns around\nlong-term use, helping to inform continued discussions around responsible and\nappropriate topical corticosteroid use and steroid stewardship in the\nmanagement of chronic inflammatory skin diseases.”\n\nAbout ZORYVE(®) (roflumilast) \nZORYVE is the number one prescribed branded topical therapy across three major\ninflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis,\nand plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an\nadvanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor.\nInhibiting PDE4, an intracellular enzyme that is an established target in\ndermatology, decreases the production of pro-inflammatory mediators. This\ndecreases inflammation in the skin and balances the skin’s immune system.\n\nDemonstrating both clinical impact and broad industry recognition, ZORYVE has\nbeen honored with multiple prestigious awards, including three from major\nbeauty magazines:\n* Allure’s “2025 Best of Beauty Breakthrough Award,” making it the first\nFDA-approved medication for atopic dermatitis, plaque psoriasis, and\nseborrheic dermatitis to win this prominent award;\n* Glamour’s 2024 Beauty and Wellness Award for “Best Eczema Product,”\nrecognizing ZORYVE cream 0.15%;\n* And most recently, Marie Claire’s “2026 Best Prescription Skin\nSolution” Award, recognizing ZORYVE cream 0.15% for eczema.\nIn addition, ZORYVE has been honored with the following recommendations:\n* National Psoriasis Foundation’s Seal of Recognition for ZORYVE cream 0.3%\nand ZORYVE foam 0.3% — the first FDA-approved prescription brand to receive\nthe honor. \n* American Academy of Dermatology (AAD) issued a strong recommendation for the\nuse of ZORYVE cream 0.15% in adults with mild to moderate atopic dermatitis,\nin updated guidelines released June 2025, as well as a strong recommendation\nfor the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream\n0.15% for children aged 6 years and older with mild to moderate atopic\ndermatitis from the AAD’s first-ever pediatric atopic dermatitis guidelines\npublished in April 2026.\nINDICATIONS\nZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate\natopic dermatitis in pediatric patients 2 to 5 years of age.\n\nZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate\natopic dermatitis in adult and pediatric patients 6 years of age and older.\n\nZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis,\nincluding intertriginous areas, in adult and pediatric patients 2 years of age\nand older.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis\nof the scalp and body in adult and pediatric patients 12 years of age and\nolder.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic\ndermatitis in adult and pediatric patients 9 years of age and older.\n\nIMPORTANT SAFETY INFORMATION \nZORYVE is contraindicated in patients with moderate to severe liver impairment\n(Child-Pugh B or C).\n\nFlammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame,\nand smoking during and immediately following application.\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for\npediatric patients with atopic dermatitis 2 to 5 years of age were upper\nrespiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis\n(1.6%), conjunctivitis (1.4%), and headache (1.1%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for\npatients with atopic dermatitis 6 years of age or older were headache (2.9%),\nnausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting\n(1.5%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for\nplaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%),\nnausea (1.2%), application site pain (1.0%), upper respiratory tract infection\n(1.0%), and urinary tract infection (1.0%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nplaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and\nnasopharyngitis (1.3%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nseborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache\n(1.1%).\n\nPlease see full Prescribing Information for ZORYVE foam\n(https://www.globenewswire.com/Tracker?data=mm4vzl6TgH9rCEG8vt_dju9GD26VK02fDsTb4bJa-Yijjs9BAJXIyKVDSY03KDG4aGtc3n-PRxlKoDXYn1SoA20OOScnYaoScm1hP6KUEKvnW7SyAl_wZq3Vcb6mA0QtOuMGE_LuCcjP4pyLRdk0wg==)\nand full Prescribing Information for ZORYVE cream\n(https://www.globenewswire.com/Tracker?data=mm4vzl6TgH9rCEG8vt_dju9GD26VK02fDsTb4bJa-Yijjs9BAJXIyKVDSY03KDG4tkjYdcJjo38DI0gdYX3TvR4t2pdOc3qoQeZYp-PCZXv3BKeMks_Alu17isiBBdTp9LMT5enhe8iHv67aOkG4Qg==).\n\nAbout Arcutis\nArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical\ndermatology company delivering meaningful innovation to address the needs of\nindividuals living with chronic inflammatory skin diseases. Over the\npast decade, Arcutis has successfully developed a robust portfolio of\nadvanced targeted topicals approved to treat three major inflammatory skin\ndiseases, driven by a commitment to solving the most persistent patient\nchallenges in dermatology. Arcutis’ unique dermatology development\nplatform, built on established scientific pathways and coupled with deep\nclinical dermatology and commercial expertise, enables us to efficiently\ndevelop, scale, and deliver our differentiated therapies while advancing a\ngrowing pipeline across a range of inflammatory dermatological conditions.\nFor more information, visit www.arcutis.com or follow Arcutis on LinkedIn\n(https://www.globenewswire.com/Tracker?data=5ngQYef9hy4raOFwyCZPrfZONVFOvssj5kptP6XXiln3EvsivZ6wuGGe-r3G-W_PZ5JD-VuwxmTP7sCuvvWQVa1TkF7gY83RgMbYPQ423X07Tu2zCIjmeYlzVIVYdpRX), Facebook\n(https://www.globenewswire.com/Tracker?data=JVr3Yjkat8491qLjARnlONDTJaUosHqOvPds4rJ82bH8FtpN5nba0_5GX26jHiPNrS71HznIsFo8Mc5dA9XFBph-3q6p09f7kyYBsXxDnpQ=), Instagram\n(https://www.globenewswire.com/Tracker?data=zdmJvptIPgfvpvqCYQPzqxr8aBPu9clHhun607mpXKhyyqHRdFQjlyEIRSZ86gb4oiKr2J0sABhwIJIVArJrMNnAu8XKnXt72zov3duvjzM=),\nand X\n(https://www.globenewswire.com/Tracker?data=KhMf1gtFIaEdGoeDi0dC45n6uShL60LPfobLESfAQeIUCYKk40ozncXBRUmCwOY0EcPzUBqAf4AqWHwggPP15Q==). \n\nForward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended. For example, statements contained\nin this press release regarding matters that are not historical facts are\nforward-looking statements. These statements are based on the Company’s\ncurrent beliefs and expectations. Such forward-looking statements include, but\nare not limited to, statements regarding the potential FDA approval of ZORYVE\ncream 0.05% in infants 3 to 24 months, clinical trial and research results\ntranslating into real world results, and the potential for ZORYVE cream and\nZORYVE foam to advance the standard of care in atopic dermatitis, plaque\npsoriasis, and seborrheic dermatitis. These statements are subject to\nsubstantial known and unknown risks, uncertainties, and other factors that may\ncause our actual results, levels of activity, performance, or achievements to\nbe materially different from the information expressed or implied by these\nforward-looking statements. Risks and uncertainties that may cause our actual\nresults to differ include risks inherent in our business, reimbursement and\naccess to our products, the impact of competition and other important factors\ndiscussed in the “Risk Factors” section of our Form 10-K filed with the\nU.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as\nany subsequent filings with the SEC. Any forward-looking statements that the\nCompany makes in this press release are made pursuant to the Private\nSecurities Litigation Reform Act of 1995, as amended, and speak only as of the\ndate of this press release. Except as required by law, we undertake no\nobligation to revise or update information herein to reflect events or\ncircumstances in the future, even if new information becomes available.\n\nContacts:\nMedia\nAmanda Sheldon, Head of Corporate Communications\nmedia@arcutis.com\n\nInvestors\nBrian Schoelkopf, Head of Investor Relations\nir@arcutis.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1b166f47-afb1-44f1-91be-2d73e97c0ec3)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-09T12:00:01.014517617Z","server_sent_at_ms":1791547201014},"received_at":"2026-10-09T12:00:01.065Z","source_url":null},"analysis":{"id":"153748","press_release_id":"165350","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"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.\n\nPhase 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.\n\nZORYVE cream 0.05% remains under FDA review for infants 3 to <24 months with a PDUFA target action date of February 23, 2027.\n\nReal-world research with patient groups highlighted topical corticosteroid hesitancy and adverse-event concerns, positioning steroid-free alternatives like ZORYVE favorably.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Positive infant atopic dermatitis data de-risk the February 2027 PDUFA decision and extend the ZORYVE label-expansion runway."},"keyFigures":{"drugName":"ZORYVE (roflumilast)","phaseOfTrial":"Phase 2 (INTEGUMENT-INFANT); Phase 3 subanalyses (ARRECTOR, DERMIS-1/2)","customDimensions":{"pdufa_date":"February 23, 2027","infants_enrolled":101,"foam_body_clear_week8":"45.5% vs 20.1% vehicle","foam_scalp_clear_week8":"66.4% vs 27.8% vehicle","infant_iga_scalp_success":"67.5%","infant_viga_ad_success_4wk":"34.4%"}},"quotedText":"The data presented at these two meetings add to the growing body of evidence supporting ZORYVE across three chronic inflammatory skin conditions and a wide range of ages, including infants, the most vulnerable and underserved patient populations.","namedEntities":{"people":[{"name":"Frank Watanabe","role":"President and CEO of Arcutis"},{"name":"Patrick Burnett","role":"Chief Medical Officer of Arcutis"},{"name":"L. Eichenfield","role":"lead investigator, INTEGUMENT-INFANT"},{"name":"M. Gooderham","role":"investigator, ARRECTOR subanalysis"},{"name":"M. Payette","role":"investigator, DERMIS-1/2 and ARRECTOR analysis"},{"name":"E. Guttman","role":"investigator, seborrheic dermatitis proteomics"},{"name":"E. Simpson","role":"investigator, real-world corticosteroid survey"},{"name":"T. Bhutani","role":"investigator, corticosteroid hesitancy analysis"},{"name":"A. Golant","role":"investigator, topical corticosteroid literature review"}],"products":["ZORYVE cream 0.05%","ZORYVE cream 0.15%","ZORYVE cream 0.3%","ZORYVE foam 0.3%"],"companies":[{"name":"Arcutis Biotherapeutics, Inc.","ticker":"ARQT","relationship":"filer"},{"name":"Mount Sinai","relationship":"research collaborator"},{"name":"National Eczema Association","relationship":"research collaborator"},{"name":"National Psoriasis Foundation","relationship":"research collaborator"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Positive Phase 2 INTEGUMENT-INFANT data and supportive Phase 3 analyses presented at medical congresses, reinforcing the ZORYVE franchise ahead of a February 2027 PDUFA date. No new regulatory or pivotal decision; supportive but routine scientific-communication news."},"tickerRelevance":{"others":[],"primary":"ARQT"},"globalImportance":28,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-cap biotech","eventGravity":"congress data presentations, no new regulatory decision","sectorWeight":"dermatology commercial-stage","pdufaCatalystProximity":"Feb 2027"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"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.\n\nPhase 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.\n\nZORYVE cream 0.05% remains under FDA review for infants 3 to <24 months with a PDUFA target action date of February 23, 2027.\n\nReal-world research with patient groups highlighted topical corticosteroid hesitancy and adverse-event concerns, positioning steroid-free alternatives like ZORYVE favorably.","key_figures":{"drugName":"ZORYVE (roflumilast)","phaseOfTrial":"Phase 2 (INTEGUMENT-INFANT); Phase 3 subanalyses (ARRECTOR, DERMIS-1/2)","customDimensions":{"pdufa_date":"February 23, 2027","infants_enrolled":101,"foam_body_clear_week8":"45.5% vs 20.1% vehicle","foam_scalp_clear_week8":"66.4% vs 27.8% vehicle","infant_iga_scalp_success":"67.5%","infant_viga_ad_success_4wk":"34.4%"}},"named_entities":{"people":[{"name":"Frank Watanabe","role":"President and CEO of Arcutis"},{"name":"Patrick Burnett","role":"Chief Medical Officer of Arcutis"},{"name":"L. Eichenfield","role":"lead investigator, INTEGUMENT-INFANT"},{"name":"M. Gooderham","role":"investigator, ARRECTOR subanalysis"},{"name":"M. Payette","role":"investigator, DERMIS-1/2 and ARRECTOR analysis"},{"name":"E. Guttman","role":"investigator, seborrheic dermatitis proteomics"},{"name":"E. Simpson","role":"investigator, real-world corticosteroid survey"},{"name":"T. Bhutani","role":"investigator, corticosteroid hesitancy analysis"},{"name":"A. Golant","role":"investigator, topical corticosteroid literature review"}],"products":["ZORYVE cream 0.05%","ZORYVE cream 0.15%","ZORYVE cream 0.3%","ZORYVE foam 0.3%"],"companies":[{"name":"Arcutis Biotherapeutics, Inc.","ticker":"ARQT","relationship":"filer"},{"name":"Mount Sinai","relationship":"research collaborator"},{"name":"National Eczema Association","relationship":"research collaborator"},{"name":"National Psoriasis Foundation","relationship":"research collaborator"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-09T12:00:15.445Z","global_importance":28,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap biotech","eventGravity":"congress data presentations, no new regulatory decision","sectorWeight":"dermatology commercial-stage","pdufaCatalystProximity":"Feb 2027"}},"durationMs":7225,"modelName":"glm-5.3-flashx"}}