Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics (Nasdaq: ARQT) announced that its product ZORYVE® (roflumilast) cream 0.15% has received a strong recommendation in the American Academy of Dermatology's (AAD) updated guidelines for adult atopic dermatitis management. ZORYVE is the first FDA-approved branded topical PDE4 inhibitor for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis.

Among newly evaluated branded topical therapies, ZORYVE stands out as the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis. The recommendation highlights the drug's efficacy in improving pruritus and disease severity, favorable tolerability, and low discontinuation rates. The treatment targets a condition affecting over 16 million adults in the United States.

Arcutis Biotherapeutics (ARQT) has initiated a Phase 2 clinical trial for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis. The INTEGUMENT-INFANT study will evaluate the safety and tolerability of the PDE4 inhibitor cream in children aged 3 months to less than 2 years over a four-week period. The trial addresses a significant unmet need, as atopic dermatitis affects 9.6 million children in the US, with up to 60% developing symptoms in their first year. ZORYVE, designed for once-daily topical application, represents a potential new treatment option in a market with limited approved therapies for infants.

Arcutis Biotherapeutics (NASDAQ: ARQT) has granted 72,000 restricted stock units (RSUs) to nine newly hired employees as part of their employment inducement package. The grants were approved by the company's Compensation Committee under the 2022 Inducement Plan, with a grant date of June 2, 2025. The RSUs will vest over a four-year period, with 25% vesting occurring on each annual anniversary of the vesting commencement date, contingent on continuous employment with Arcutis. This announcement is made in compliance with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics (ARQT) presented new long-term data for ZORYVE cream at the 2025 RAD Conference, showing significant efficacy in treating atopic dermatitis. The Phase 3 INTEGUMENT-OLE study demonstrated that children ages 2-5 who achieved disease clearance and switched to twice-weekly ZORYVE cream 0.05% maintained disease control for a median of 238 days. By week 52, 63.1% of participants aged 2-5 years and 55.7% of those 6 years and over achieved disease clearance or almost clear status. Notable improvements in itch reduction were observed, with about half of participants achieving no or minimal itch. The treatment showed strong safety profile with low treatment-related adverse events: 2.5% in ages 2-5 and 4.7% in ages 6 and over.

Arcutis Biotherapeutics (NASDAQ: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, June 10, 2025, at 4:00 pm EDT. The event will be accessible via webcast in the "Events" section of Arcutis' website, with the replay remaining available for 180 days after the conference.

The FDA has approved ZORYVE® (roflumilast) topical foam 0.3% for treating plaque psoriasis in patients 12 years and older. This marks Arcutis Biotherapeutics' (NASDAQ: ARQT) fifth FDA approval for ZORYVE in under three years. The once-daily, steroid-free treatment demonstrated significant efficacy in clinical trials, with 66.4% of patients achieving Scalp-IGA Success and 45.5% achieving Body-IGA Success at Week 8. The foam formulation specifically addresses the needs of over half of the 9 million U.S. psoriasis patients who experience scalp involvement. Clinical trials showed rapid itch relief within 24 hours and strong safety profile, with only mild to moderate adverse events. The treatment is now widely available through dermatology pharmacy channels, with patient support programs including copay assistance for eligible commercially insured patients.

Arcutis Biotherapeutics (NASDAQ: ARQT) has announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium in the JEADV Clinical Practice journal. The statements focus on improving diagnosis, treatment, and patient care for genital psoriasis, a condition affecting approximately 6 million Americans. The consensus, developed through a modified Delphi process and literature review of 78 publications, addresses three key areas: physical diagnosis and patient conversations, quality of life impact, and treatment decisions. The initiative aims to bridge gaps in clinician-patient communication and establish standardized care practices for genital psoriasis, which is often underreported and undertreated despite affecting about two-thirds of the nine million individuals with plaque psoriasis. The statements emphasize early diagnosis, comprehensive examination protocols, and shared decision-making in treatment selection.

Arcutis Biotherapeutics (NASDAQ: ARQT) announced the publication of positive Phase 3 trial results for ZORYVE® (roflumilast) foam 0.3% in JAMA Dermatology. The ARRECTOR trial evaluated the treatment in 432 patients with scalp and body psoriasis across 49 sites in the US and Canada.

Key results at Week 8 showed: 66.4% of patients achieved Scalp-IGA success vs 27.8% for vehicle, 45.5% achieved Body-IGA success vs 20.1% for vehicle, and 65.3% experienced significant scalp itch reduction vs 30.3% for vehicle. Notably, improvement in itch was observed within 24 hours of first application.

The treatment was well-tolerated with low incidence of adverse events. An sNDA is under FDA review with a PDUFA date of May 22, 2025.

Arcutis Biotherapeutics (NASDAQ: ARQT) reported strong Q1 2025 financial results with net product revenue of $63.8 million, marking a 196% increase year-over-year for ZORYVE®. The quarter showed a 10% demand growth, establishing ZORYVE as the most prescribed branded non-steroidal topical treatment across three inflammatory skin conditions. Key highlights include: coverage by all three largest national Pharmacy Benefit Managers, expanded Medicaid coverage, and a stay in patent litigation against Padagis. The company reported revenues breakdown: $23.4M for ZORYVE cream 0.3%, $30.2M for ZORYVE foam 0.3%, and $10.2M for ZORYVE cream 0.15%. Despite growth, Arcutis posted a net loss of $25.1 million ($0.20 per share). The company maintains a strong cash position of $198.7 million and anticipates a PDUFA action date of May 22, 2025, for ZORYVE foam 0.3% for psoriasis treatment.