Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

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.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced it will host a virtual Investor Day and report Q3 2025 financial results on October 28, 2025. The event will begin at 10:30 a.m. ET, following the pre-market financial results release.

The Investor Day will feature presentations on ZORYVE's growth strategy, clinical development updates for new indications and ARQ-234, and the company's capital allocation strategy. The event includes a fireside chat with Douglas DiRuggiero, founding president of the Georgia Dermatology Physician Assistant Society, followed by a Q&A session.

Arcutis Biotherapeutics (Nasdaq: ARQT) will present new data analyses for ZORYVE® (roflumilast) at the 34th Annual EADV Congress. The presentations highlight three key findings:

1. ZORYVE foam 0.3% showed significant efficacy in treating seborrheic dermatitis across diverse skin types, with 79.5% success rate vs 58.0% for vehicle in the STRATUM trial.

2. ZORYVE cream 0.05% demonstrated improved quality of life and reduced family impact in children aged 2-5 years with atopic dermatitis in the INTEGUMENT-PED trial.

3. Both ZORYVE cream 0.3% and foam 0.3% showed effectiveness in treating plaque psoriasis with facial/genital involvement in the DERMIS-1/2 and ARRECTOR trials.

Arcutis Biotherapeutics (NASDAQ:ARQT) announced that its flagship product ZORYVE has received the prestigious 2025 Best of Beauty Breakthrough Award from Allure magazine. ZORYVE is the first FDA-approved medication for three major inflammatory skin conditions: atopic dermatitis (eczema), plaque psoriasis, and seborrheic dermatitis to win this award.

The product has emerged as the number one prescribed branded topical therapy across these three conditions combined. ZORYVE is a steroid-free, once-daily treatment available in both cream and foam formulations, featuring a unique water-based, moisturizing formula that can be used anywhere on the body and is suitable for all skin and hair types.