Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

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.