Welcome to our dedicated page for Arcutis Biotherapeutics news (Ticker: ARQT), a resource for investors and traders seeking the latest updates and insights on Arcutis Biotherapeutics stock.
News for Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) centers on its role as a commercial-stage medical dermatology and biopharmaceutical company focused on immune-mediated skin diseases. Company announcements frequently highlight developments in its ZORYVE (roflumilast) topical franchise for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis, along with updates on its broader immuno-dermatology pipeline.
Investors and clinicians following ARQT news can expect detailed coverage of regulatory milestones, such as U.S. Food and Drug Administration (FDA) approvals and supplemental new drug application (sNDA) acceptances for new age groups and indications. Releases describe label expansions for ZORYVE cream and foam, including approvals for pediatric atopic dermatitis and seborrheic dermatitis, and FDA review timelines for potential new pediatric plaque psoriasis indications.
Arcutis also reports on clinical trial progress and data presentations. Recent news includes completion of enrollment in pediatric studies like INTEGUMENT-INFANT, publication of long-term safety and efficacy data for ZORYVE foam 0.3% in seborrheic dermatitis, and new Phase 3 analyses showing improvements in itch, sleep disruption, and long-term disease control with ZORYVE cream 0.15% and 0.05% in atopic dermatitis.
Financial and corporate updates form another key news category. The company issues quarterly earnings releases detailing net product revenue for ZORYVE, outlines strategies for sustainable growth, and provides guidance on future net product sales. Additional items include inducement equity grants, participation in investor conferences, and board-level changes disclosed via press releases and Form 8-K filings.
News flow also covers pipeline and strategic priorities, such as Phase 2 proof-of-concept trials of ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa, and early clinical development plans for ARQ-234, a CD200 receptor checkpoint agonist being developed as a potential biologic for atopic dermatitis. Together, these updates give readers insight into Arcutis’ commercial performance, regulatory trajectory, and ongoing research in immuno-dermatology.
Arcutis (Nasdaq: ARQT) completed enrollment in the INTEGUMENT-INFANT Phase 2 open-label study evaluating investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis.
Topline results are anticipated in Q1 2026. The U.S. FDA approved ZORYVE cream 0.05% for children ages 2 to 5 years in October 2025. The company described the cream as a selective topical PDE4 inhibitor formulated for delicate infant skin and noted strong enrollment interest from parents.
Arcutis Biotherapeutics (Nasdaq: ARQT) reported inducement equity grants to six newly hired employees totaling 51,000 restricted stock units (RSUs) under the company's 2022 Inducement Plan.
The awards were approved by the Compensation Committee with a grant date of November 3, 2025 and were disclosed on November 7, 2025 in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs vest over four years with 25% vesting on each annual anniversary, subject to continued employment on each vesting date.
Arcutis (Nasdaq: ARQT) reported publication of Phase 2 long-term safety and efficacy data for ZORYVE foam 0.3% in seborrheic dermatitis, showing safety, tolerability, and improving efficacy through 52 weeks.
In the open-label extension (n=400), TEAEs occurred in 32.5%, SAEs in 1.8% (none treatment-related), and discontinuations for AEs were 1.3%. Investigator Global Assessment (IGA) outcomes: 56.4% IGA 0/1 at Week 4, 76% at Week 24, and 80.4% at Week 52 (n=46 completers); 52.2% achieved IGA Clear (0) at Week 52. Itch improvement (WI-NRS ≥4 baseline) reached 71.3% at Week 24 and 58.1% at Week 52.
Arcutis Biotherapeutics (Nasdaq: ARQT) launched the Free to Be Me campaign on Oct 30, 2025 featuring Tori Spelling and her daughter Stella to raise awareness of inflammatory skin diseases and encourage patients to discuss long‑term treatment with their healthcare providers.
The campaign highlights ZORYVE (roflumilast), described as the #1 prescribed branded topical for eczema, plaque psoriasis, and seborrheic dermatitis, and summarizes clinical evidence: 31% clear/almost clear at 4 weeks (ZORYVE cream vs 14% inactive) and 77% clear/almost clear at 8 weeks (ZORYVE foam vs 53% inactive). The company cites ~4,200 trial participants across eight pivotal studies and notes common side effects including headache and nausea.
Arcutis (Nasdaq: ARQT) announced the commercial launch of ZORYVE cream 0.05% for treatment of mild to moderate atopic dermatitis in children ages 2 to 5 in the U.S. The product received FDA approval on October 6, 2025 and is becoming available in pharmacies the week of October 30, 2025. Clinical trials reported significant clearance of signs and symptoms and meaningful itch improvement. ZORYVE is a once-daily, steroid-free topical that can be used anywhere on the body for any duration, and Arcutis is offering patient support via the ZORYVE Direct Program, a copay savings card, and the Arcutis Cares patient assistance program.
Arcutis (NASDAQ: ARQT) reported Q3 2025 net product revenue of $99.2 million, up 122% year-over-year and 22% sequentially. Revenue breakdown: $30.5M ZORYVE cream 0.3%, $18.9M cream 0.15%, and $49.8M topical foam 0.3%. The company achieved net income of $7.4M ($0.06 per share) versus a net loss of $41.5M in Q3 2024. Cash and marketable securities were $191.4M as of Sept 30, 2025. Clinical and regulatory highlights include FDA approval of ZORYVE cream 0.05% for atopic dermatitis in children ages 2–5 and initiation of Phase 2 trials of ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa. Initial 2026 net product sales guidance: $455–$470M.
Arcutis (Nasdaq: ARQT) said company management will participate in two investor conferences in November 2025. The company will appear at Guggenheim’s 2nd Annual Healthcare Innovation Conference with a fireside chat on Tuesday, November 11, 2025 at 8:30 am ET, and at the TD Cowen Immunology & Inflammation Summit with a fireside chat on Wednesday, November 12, 2025 at 9:00 am ET.
Webcasts for both events can be accessed in the Events section of the company website, and replays will be available for 180 days after each conference.
Arcutis (NASDAQ: ARQT) will present Phase 3 and 52-week extension data showing ZORYVE® (roflumilast) cream 0.15% and 0.05% improved quality of life by reducing sleep disruption and itch in patients with atopic dermatitis aged ≥2 years.
Key findings: WI-NRS improvements at Week 4 were 2.6 vs 1.6 (ZORYVE vs vehicle; P<0.001/ <0.01), sleep impact reduced across age groups, treatment-related AEs ≤6% and serious AEs <1%, application-site pain ~1.5% in pivotal trials. In the 52-week OLE, mean BSA fell (INTEGUMENT-1/2: 14.8% to 3.7%; PED: 22.3% to 4.9%), vIGA-AD 0/1 at 56 weeks 55.7% and 63.1%, and durable control with twice-weekly maintenance (median 238–281 days).
Arcutis (Nasdaq: ARQT) announced FDA approval of ZORYVE cream 0.05% for topical treatment of mild-to-moderate atopic dermatitis in children ages 2–5, with commercial availability expected by end of October 2025. The approval is the sixth FDA approval for the ZORYVE portfolio in just over three years. Clinical data from INTEGUMENT-PED (n=652) showed rapid improvement: vIGA-AD success 25.4% vs 10.7% (vehicle) at Week 4 and EASI-75 39.4% vs 20% at Week 4. Long-term data showed 71.9% EASI-75 after 56 weeks and median disease-control of 238 days on proactive twice-weekly dosing.
Arcutis Biotherapeutics (Nasdaq: ARQT) reported the grant of 94,500 restricted stock units to 12 newly hired employees as inducement awards under the 2022 Inducement Plan.
The awards were approved by the Compensation Committee, granted with a grant date of October 1, 2025, and disclosed on October 3, 2025 in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs vest over four years, with 25% vesting on each annual anniversary, contingent on continuous employment through each vesting date.