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.
Arcutis Biotherapeutics reports company developments as a commercial-stage biopharmaceutical company focused on immuno-dermatology and medical dermatology. Its recurring updates center on ZORYVE (roflumilast) cream and foam, a topical PDE4 inhibitor portfolio used across inflammatory skin diseases including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis.
Company news commonly covers ZORYVE net product revenue, demand trends for branded non-steroidal topical treatments, clinical data from dermatology studies, FDA submissions tied to potential label expansion, medical-meeting presentations, guideline references, sales-force and commercial updates, conference participation, and equity grants made under Nasdaq inducement-grant rules.
Arcutis Biotherapeutics (Nasdaq: ARQT) will report its fourth quarter and full year 2025 financial results and provide a business update on Wednesday, February 25, 2026 after U.S. market close. The company will host a conference call and webcast the same day at 4:30 p.m. ET, with presentation materials available in the company Events section and an archived replay posted afterward.
Arcutis management will also present at the Guggenheim Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026 with a fireside chat at 11:30 a.m. ET; that webcast and a replay will be accessible via the company Events page for 180 days.
Arcutis Biotherapeutics (Nasdaq: ARQT) on Jan 21, 2026 published nationwide survey results showing high patient concern about topical steroid use and a preference gap toward proactive long‑term management for chronic inflammatory skin diseases. Key findings: 88% of adults and 91% of parents reported concern about steroid side effects; 72% of adults and 80% of children experienced uncontrolled disease at least monthly; and only 20% of adults are completely confident in current treatments. The survey highlights emotional, social, and daily‑life impacts and indicates demand for safe, effective non‑steroidal long‑term options.
Arcutis (Nasdaq: ARQT) outlined 2026 strategic priorities focused on expanding the commercial footprint of ZORYVE and advancing its pipeline. Management reiterated full-year ZORYVE net product sales guidance of $455–$470 million and plans a targeted ~20% dermatology sales force expansion. Key development milestones include topline INTEGUMENT-INFANT Phase 2 results in Q1 2026 and an expected sNDA submission in Q3 2026 for ZORYVE cream 0.05% in infants; an FDA PDUFA target action date of June 29, 2026 for the sNDA for ZORYVE cream 0.3% in ages 2–5; Phase 2 proof‑of‑concept trials in vitiligo and hidradenitis suppurativa with program decisions in Q4 2026 and Q1 2027; and initiation of Phase 1 enrollment for ARQ-234 in Q1 2026. The company cited a transition to positive cash flows to fund growth and pipeline investment.
Arcutis (Nasdaq: ARQT) appointed Amit Munshi to its Board of Directors effective December 4, 2025 and honored the retirement of founder and long‑serving board member Bhaskar Chaudhuri, PhD. Dr. Chaudhuri will remain as a consultant.
Management highlights cited: ZORYVE described as the number one prescribed branded topical across three indications, and Munshi’s track record includes raising $900M in equity, securing $800M in partnerships, and participating in a $6.7B acquisition during prior leadership roles.
Arcutis (Nasdaq: ARQT) announced FDA acceptance of a supplemental NDA for ZORYVE cream 0.3% to expand the plaque psoriasis indication to children ages 2 to 5. The FDA set a PDUFA target action date of June 29, 2026. If approved, ZORYVE 0.3% would be the first topical PDE4 inhibitor indicated for children as young as two and would extend the current approval that covers ages six and up.
The submission is supported by a 4-week MUSE systemic exposure study and by long-term open-label safety and tolerability data showing persistence of efficacy across studied ages.
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.