Financial Performance - Q3 2025 net product revenue for ZORYVE was $99.2 million, a 122% increase compared to Q3 2024, and a 22% increase compared to Q2 2025[4] - ZORYVE net product sales for Q3 2025 were $99.2 million, driven by increasing demand and improved gross-to-net pricing[8] - Product revenue for Q3 2025 reached $99.219 million, a significant increase from $44.755 million in Q3 2024, representing a growth of 121%[27] - Total revenues for the nine months ended September 2025 were $246.569 million, compared to $125.182 million for the same period in 2024, marking a 97% increase[27] - Net income for Q3 2025 was $7.4 million, compared to a net loss of $41.5 million in Q3 2024[16] - Net income for Q3 2025 was $7.410 million, a recovery from a net loss of $41.537 million in Q3 2024[27] - Basic earnings per share for Q3 2025 were $0.06, compared to a loss of $0.33 per share in Q3 2024[27] Expenses - Research and development expenses for Q3 2025 were $19.6 million, consistent with the previous year[14] - Selling, general, and administrative expenses for Q3 2025 were $62.4 million, an increase from $58.8 million in Q3 2024[15] - Operating expenses for Q3 2025 totaled $90.693 million, up from $83.821 million in Q3 2024, reflecting an increase of 8%[27] - Research and development expenses for the nine months ended September 2025 were $56.600 million, down from $61.940 million in the same period of 2024, a decrease of 9%[27] - Selling, general, and administrative expenses increased to $62.404 million in Q3 2025 from $58.817 million in Q3 2024, an increase of 4%[27] - Interest expense for the nine months ended September 2025 was $9.082 million, down from $21.617 million in the same period of 2024, a reduction of 58%[27] - The company reported other income of $2.035 million in Q3 2025, compared to $4.182 million in Q3 2024, a decrease of 51%[27] Product Development - ZORYVE cream 0.05% received FDA approval for treating atopic dermatitis in children as young as 2 years old in October 2025[4] - The company provided initial 2026 full year net product sales guidance of $455–$470 million[17] - ZORYVE is projected to achieve peak sales of $2.6–$3.5 billion annually across current and potential future indications[7] - The company is preparing to initiate a Phase 1 study of ARQ-234, a potential biologic treatment for atopic dermatitis[9] Cash and Securities - Cash, cash equivalents, and marketable securities totaled $191.4 million as of September 30, 2025, down from $228.6 million at the end of 2024[16] - The weighted-average diluted shares used in computing earnings per share for Q3 2025 were 132,885 thousand, unchanged from Q3 2024[27]

Q3 2025 net product revenue for ZORYVE® (roflumilast) was $99.2 million, a 122% increase compared to Q3 of 2024, and a 22% increase compared to Q2 of 2025 ZORYVE cream 0.05% received U.S. Food and Drug Administration (FDA) approval for the treatment of atopic dermatitis in children down to 2 years of age in October Company provides initial 2026 full year net product sales guidance of $455–$470 million WESTLAKE VILLAGE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) ...

New data from Phase 3 studies show once-daily ZORYVE cream helped reduce sleep disruptions in individuals with atopic dermatitis aged ≥2 yearsNew long-term data demonstrate that ZORYVE cream was well-tolerated and provided continued disease control for individuals who switched to twice-weekly treatment WESTLAKE VILLAGE, Calif. and LAS VEGAS, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovation ...

Core Insights - The FDA has approved Arcutis Biotherapeutics' ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years, providing a steroid-free alternative for long-term use [1][6][23] - Approximately 1.8 million children in the U.S. aged 2 to 5 are treated for atopic dermatitis, highlighting a significant market need for effective treatments [2][6] - ZORYVE cream demonstrated rapid and significant improvements in clinical trials, with 40% of children achieving a 75% improvement in eczema symptoms within four weeks [2][12] Company Overview - Arcutis Biotherapeutics is focused on developing innovative treatments for immune-mediated dermatological diseases, with a growing portfolio of advanced topical therapies [30] - The approval of ZORYVE cream 0.05% marks the sixth FDA approval for the ZORYVE product line in just over three years, indicating strong regulatory momentum [1][6] - The company aims to ensure predictable access to ZORYVE through patient support programs, including the ZORYVE Direct Program and Arcutis Cares™ for financially eligible patients [4][30] Clinical Data - The FDA approval was based on results from the INTEGUMENT-PED Phase 3 trial, which involved 652 children and demonstrated rapid disease clearance and safety [10][11] - In the INTEGUMENT-PED trial, 25.4% of children treated with ZORYVE achieved a 'Clear' or 'Almost Clear' status by Week 4, compared to 10.7% in the vehicle group [12] - The long-term extension study (INTEGUMENT-OLE) showed that 71.9% of participants maintained a 75% improvement in eczema severity after 56 weeks of treatment [16] Market Context - Atopic dermatitis affects approximately 9.6 million children in the U.S., with a significant impact on family life due to sleep disruption and emotional distress [19][20] - ZORYVE is positioned as a leading topical therapy for atopic dermatitis, with recognition from industry awards, including Allure's "2025 Best of Beauty Breakthrough Award" [22][21] - The product's formulation targets underlying inflammation without compromising the skin barrier, making it particularly suitable for young children [3][21]

Core Viewpoint - Arcutis Biotherapeutics, Inc. (ARQT) has experienced significant stock performance, with a 23% increase over the past month and a 35.3% gain since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Biomedical and Genetics industry [1][3]. Financial Performance - The company has a strong record of positive earnings surprises, having beaten earnings consensus estimates in the last four quarters. In the latest earnings report on August 6, 2025, Arcutis reported an EPS of -$0.13, surpassing the consensus estimate of -$0.18, and beat the revenue estimate by 12.32% [2]. - For the current fiscal year, Arcutis is expected to post earnings of -$0.46 per share on revenues of $329.85 million, reflecting a 60.34% change in EPS and a 67.83% change in revenues. For the next fiscal year, the company is projected to earn $0.10 per share on revenues of $430.73 million, indicating a year-over-year change of 121.2% in EPS and 30.58% in revenues [3]. Valuation Metrics - Despite being at a 52-week high, the future valuation metrics are crucial for assessing potential stock performance. The Zacks Style Scores provide insights into various investment styles, with Arcutis having a Value Score of D, a Growth Score of A, and a Momentum Score of C, resulting in a VGM Score of B [4][6]. Zacks Rank - Arcutis Biotherapeutics holds a Zacks Rank of 2 (Buy), supported by a solid earnings estimate revision trend. This rank is considered more significant than the VGM Score, indicating a favorable outlook for the stock [7][8].

WESTLAKE VILLAGE, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, today announced that it will report third quarter 2025 financial results on Tuesday, October 28, 2025, before the U.S. financial markets open. The Company will also host a virtual Investor Day the same day at 10:30 a.m. ET. In addition to discussing third quarter 2025 financial results, the Investor Day will feature: An in-dept ...

Group 1 - Arcutis Biotherapeutics (ARQT) is currently breaking out past two buy points, making it a top stock to watch in the S&P 500 for 2025 [1] - The company specializes in developing dermatology treatments for immune-related skin diseases and conditions, with its main product Zoryve foam approved by the U.S. FDA [1] - The Dow Jones index was flat as President Trump prepared for shutdown talks, while stocks like EA, Nvidia, and Tesla experienced rallies [2] Group 2 - Palantir is facing competition from Lockheed Martin as it aims for significant growth in the S&P 500, being noted as the index's biggest winner in 2025 [4] - The market is currently influenced by AI and gold, which are yielding substantial winners, with several stocks joining the IBD 50 list [4] - Despite a recent decline in indexes, stocks like Nvidia and Palantir are nearing buy points, with upcoming Fed inflation data expected to impact market movements [4]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Arcutis Biotherapeutics, Inc. (ARQT) - ARQT currently holds a Momentum Style Score of B, indicating potential as a solid momentum pick [3][12] - The company has a Zacks Rank of 2 (Buy), which is associated with a strong track record of outperformance [4][12] Performance Metrics - Over the past week, ARQT shares increased by 0.52%, while the Zacks Medical - Biomedical and Genetics industry remained flat [6] - In a longer timeframe, ARQT's monthly price change is 10.54%, significantly outperforming the industry's 0.92% [6] - Over the last quarter, ARQT shares rose by 25.73%, and over the past year, they increased by 90.11%, compared to the S&P 500's gains of 9.31% and 17.01%, respectively [7] Trading Volume - ARQT's average 20-day trading volume is 1,603,419 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, two earnings estimates for ARQT have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$0.55 to -$0.46 [10] - For the next fiscal year, two estimates have also moved upwards with no downward revisions [10]

Core Insights - Arcutis Biotherapeutics is presenting new data on ZORYVE (roflumilast) efficacy for seborrheic dermatitis, atopic dermatitis, and psoriasis at the EADV Congress in Paris from September 17-20, 2025 [1] Efficacy of ZORYVE - ZORYVE foam 0.3% shows significant improvement in seborrheic dermatitis, with an Investigator Global Assessment (IGA) Success rate of 79.5% compared to 58.0% for the vehicle at Week 8 [5] - The treatment is effective across diverse populations, with similar efficacy observed among different races and ethnicities [5] - ZORYVE cream 0.05% demonstrates improved quality of life and reduced family impact in children aged 2-5 years with atopic dermatitis [4][6] - Both ZORYVE cream 0.3% and foam 0.3% improve signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement [7] Safety and Tolerability - ZORYVE foam 0.3% is well tolerated, with improvements in hypopigmentation and hyperpigmentation observed across all subgroups [5] - The treatment has shown minimal irritation at the application site in children, indicating good tolerability [6] Product Information - ZORYVE is the leading prescribed topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis [10] - The product is a selective phosphodiesterase-4 (PDE4) inhibitor, targeting inflammatory mediators [10] - ZORYVE cream 0.3% and foam 0.3% are FDA-approved for various age groups, with specific indications for plaque psoriasis and seborrheic dermatitis [11][12][13] Company Commitment - Arcutis Biotherapeutics emphasizes its commitment to advancing innovative therapies for inflammatory skin diseases, aiming to improve patient lives [9][17]

Core Insights - Arcutis Biotherapeutics' product ZORYVE has received the 2025 Best of Beauty Breakthrough Award from Allure magazine, marking it as the first prescription topical medication for eczema, plaque psoriasis, and seborrheic dermatitis to achieve this recognition [1][6][9] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent patient needs in dermatological conditions [17] Product Highlights - ZORYVE is recognized for its unique profile in dermatology, being the number one prescribed branded topical therapy for eczema, plaque psoriasis, and seborrheic dermatitis [3][7][9] - The product is a highly selective and potent phosphodiesterase-4 (PDE4) inhibitor, designed to be safe and effective for various inflammatory skin diseases [4][10] - ZORYVE is available in a once-daily, steroid-free topical foam or cream formulation that can be applied anywhere on the body, suitable for all skin and hair types [4][11] Award Significance - The Allure Best of Beauty Breakthrough Award is a prestigious honor, with fewer than 10 products typically winning in this category, highlighting ZORYVE's revolutionary impact on skincare [6][9] Clinical and Safety Information - ZORYVE has been shown to be safe and well-tolerated, providing rapid symptom relief and has been prescribed over 1 million times by healthcare providers [9][11] - The product is indicated for use in patients aged 6 years and older for various conditions, including mild to moderate atopic dermatitis and plaque psoriasis [12][13]