Core Insights - Arcutis Biotherapeutics has received FDA approval for ZORYVE (roflumilast) topical foam 0.3% for treating plaque psoriasis in patients aged 12 and older, marking a significant advancement in immuno-dermatology [1][5] - ZORYVE foam is a once-daily, steroid-free treatment that is now widely available, addressing the needs of nearly 9 million people in the U.S. living with plaque psoriasis, particularly those with scalp involvement [2][5] Product Details - ZORYVE foam demonstrated significant improvements in clinical trials, achieving Scalp-Investigator Global Assessment (S-IGA) Success in 66.4% of patients compared to 27.8% for the vehicle foam at Week 8 [8] - The foam also provided rapid itch relief, with 65.3% of patients experiencing a clinically significant reduction in scalp itch compared to 30.3% for the vehicle [10] - ZORYVE is indicated for both plaque psoriasis and seborrheic dermatitis, with a focus on hard-to-treat areas such as the scalp and body [14][15] Clinical Trial Results - The approval was supported by positive results from Phase 2 and pivotal Phase 3 trials, enrolling 736 adults and adolescents with mild to severe plaque psoriasis [7] - In the ARRECTOR study, 45.5% of individuals treated with ZORYVE foam achieved Body-IGA Success compared to 20.1% for the vehicle foam at Week 8 [8] - The treatment was well tolerated, with low incidence of adverse events, primarily mild to moderate in severity [12] Market Context - The approval of ZORYVE foam is the fifth for the product in less than three years, highlighting Arcutis' commitment to addressing urgent needs in dermatology [3][5] - The company aims to provide predictable access to ZORYVE through programs that assist patients with adherence and reduce out-of-pocket costs [4][21] Future Engagement - Arcutis will host a virtual Key Opinion Leader Event on June 2, 2025, to discuss the treatment landscape for plaque psoriasis, featuring insights from a leading expert [4][5]

Core Insights - Arcutis Biotherapeutics announced positive results from a pivotal Phase 3 study of ZORYVE (roflumilast) foam 0.3% for treating psoriasis of the scalp and body, published in JAMA Dermatology [1][9] Efficacy Results - ZORYVE foam demonstrated significant improvements in co-primary efficacy endpoints, with 66.4% achieving Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% achieving Body-Investigator Global Assessment (B-IGA) Success at Week 8, compared to 27.8% and 20.1% for the vehicle, respectively (P<0.0001) [4][5] - Clinically meaningful improvements in scalp itch were observed, with 65.3% of ZORYVE-treated individuals achieving a significant reduction in itch compared to 30.3% for the vehicle at Week 8 (P<0.0001) [6][8] - At Week 8, 70.9% of ZORYVE-treated individuals achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) compared to 31.3% for the vehicle (P<0.001) [13] Study Design - The ARRECTOR study was a Phase 3, randomized, double-blinded, vehicle-controlled trial involving 432 participants aged 12 years and older across 49 sites in the U.S. and Canada [3][5] Safety and Tolerability - ZORYVE foam was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar to the vehicle group; common adverse events included headache, diarrhea, and nausea [8][9] - Investigator-rated application-site tolerability showed no evidence of irritation for at least 99.2% of patients at all time points [8] Regulatory Status - A Supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025 [5][11] Market Context - Psoriasis affects approximately nine million people in the U.S., with more than half experiencing scalp involvement, highlighting the need for effective treatment options [10][11]

Core Insights - Arcutis Biotherapeutics reported strong financial performance in Q1 2025, driven by significant demand growth for its ZORYVE portfolio, which offers a safe alternative to steroids [2][6][10] - The company is expanding its market presence with additional indications and coverage for ZORYVE, alongside a promising pipeline of products [2][6][8] Financial Performance - Q1 2025 net product revenue for ZORYVE reached $63.8 million, marking a 196% increase compared to Q1 2024, but a 2% decrease from Q4 2024 [6][10] - Total revenues for Q1 2025 were $65.8 million, compared to $49.6 million in Q1 2024 [10][24] - The net loss for Q1 2025 was $25.1 million, or $0.20 per share, an improvement from a net loss of $35.4 million, or $0.32 per share, in Q1 2024 [14][24] Product Updates - ZORYVE cream and foam are approved for treating various skin conditions, with ZORYVE cream 0.3% being the most prescribed non-steroidal topical treatment for plaque psoriasis and atopic dermatitis [3][4][7] - The company has submitted supplemental New Drug Applications (sNDAs) for ZORYVE cream 0.05% for children and ZORYVE foam for scalp and body psoriasis, with action dates set for October 13, 2025, and May 22, 2025, respectively [7][10] Market Expansion - Over 425,000 prescriptions for ZORYVE cream 0.3% have been filled since its launch, indicating strong physician and patient satisfaction [7] - The company is expanding Medicaid coverage, with over 50% of recipients now covered, and all three largest national Pharmacy Benefit Managers (PBMs) covering the entire ZORYVE portfolio [2][6] Research and Development - Arcutis is advancing its pipeline, including ARQ-255 for alopecia areata, with data expected in mid-2025 [8] - The company is also developing ARQ-234, a potential biologic treatment for atopic dermatitis, with plans to submit an Investigational New Drug application in 2025 [8] Corporate Developments - Latha Vairavan was appointed as Chief Financial Officer effective May 6, 2025 [15] - The company obtained two new U.S. patents related to topical roflumilast compositions in Q1 2025 [15]