WESTLAKE VILLAGE, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET. A live webcast of the call and th ...

Core Insights - Arcutis Biotherapeutics has received FDA approval for its product ZORYVE, a PDE4 inhibitor, which expands the drug's existing label [1] - The company focuses on small and microcap biopharmaceuticals, where mispricing is most intense and institutional attention is limited [1] - The analyst team consists mainly of high-ranking Life Sciences students from top UK universities, aiming to improve the accuracy of clinical stage equity research [1] Company Overview - ZORYVE is positioned favorably among physicians due to its mechanism of action as a PDE4 inhibitor [1] - The company targets young, often clinical stage biopharmaceutical firms that typically lack institutional coverage [1] Market Dynamics - Retail investors make up the majority of public ownership in these small biopharmaceutical companies, leading to price movements that may not reflect material information [1] - Analyst coverage from investment banks often results in significant market movements, despite potential conflicts of interest [1]

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with mild to moderate atopic dermatitis (AD)Recommendation reflects ZORYVE’s proven efficacy, safety, and tolerability as a next-generation, steroid-free, topical phosphodiesterase-4 (PDE4) inhibitorAmong newly evaluated branded topical therapies, ZORYVE is the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis in AAD’s focuse ...

Group 1 - The article expresses a beneficial long position in the shares of ARQT, indicating a positive outlook on the company's stock performance [1] - The author emphasizes that the opinions presented are personal and not influenced by any business relationships with the mentioned companies [1] - The article does not provide individualized investment advice, urging readers to conduct their own due diligence before making investment decisions [2] Group 2 - The commentary highlights that past performance is not indicative of future results, cautioning readers about the inherent risks in investing [3] - It clarifies that the views expressed may not reflect those of Seeking Alpha as a whole, indicating a diversity of opinions among analysts [3] - The article notes that analysts may not be licensed or certified, which could affect the reliability of the information presented [3]

Group 1 - The article discusses the challenges of finding biotech stocks with strong factor grades, highlighting the high stakes involved in the biotechnology sector [1] - Arcutis Biotherapeutics is identified as a promising biotech stock that meets the criteria for decent factor grades [1] - The author expresses a commitment to building a hedge fund focused on clear purpose and disciplined investment strategies [1]

Summary of Arcutis Biotherapeutics (ARQT) FY Conference Call Company Overview - **Company**: Arcutis Biotherapeutics (ARQT) - **Industry**: Biopharmaceuticals, specifically dermatology - **Key Products**: XEREVE (topical PDE4 inhibitor) for various dermatological conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis [3][4] Core Points and Arguments 1. **Company Growth and Product Approvals**: - Arcutis has been operational for over nine years and has five FDA-approved indications [3] - Recent approval for a foam product targeting scalp and body psoriasis [4] - First quarter revenue reached approximately $65 million, reflecting a 10% volume growth [5] 2. **Drivers of Growth**: - **Label Expansion**: Recent approvals and ongoing trials for atopic dermatitis in younger patients [6][26] - **Coverage Expansion**: Over half of Medicaid lives have access to XEREVE, with expectations for continued growth in Medicare coverage [7][8] - **Market Shift**: Transition from topical steroids to advanced nonsteroidal treatments, with dermatologists increasingly recognizing the need for alternatives [9][12] 3. **Market Dynamics**: - The overall topical market is stagnant, but the branded nonsteroidal market grew by about 50% year-over-year [22] - The company anticipates continued growth driven by label expansions and increased coverage [23] 4. **Product Launch Performance**: - Initial launch of XEREVE for psoriasis was slow but has since gained momentum; foam product launch exceeded expectations due to high unmet need [20][21] 5. **Future Opportunities**: - Potential for new indications based on published data showing efficacy in various diseases [24] - Upcoming PDUFA date in October for expanding use in younger atopic dermatitis patients [26] 6. **Partnerships and Market Strategy**: - Co-commercialization partnership with Kawa to reach primary care physicians, allowing Arcutis to leverage existing sales forces [34][36] - Focus on expanding coverage in government sectors, particularly Medicaid and Medicare [45][46] 7. **Intellectual Property and Litigation**: - Ongoing litigation with Patagus regarding generic competition; current litigation is paused, allowing Arcutis to maintain exclusivity for 17 months [55] 8. **Pipeline Development**: - Two additional assets in development: ARQ-255 (topical JAK inhibitor) and ARQ-234 (immune checkpoint agonist) [56][60] - Plans to open IND for ARQ-234 later this year [62] 9. **Financial Position**: - Cash balance of approximately $200 million with a debt facility of $100 million; expected to reach cash flow breakeven by 2026 [64][66] 10. **Investor Sentiment**: - The stock is considered undervalued, trading at five times current year revenues, presenting a buying opportunity [80][81] Other Important Content - **Market Research Insights**: Parents show reluctance to use steroids on children, highlighting the demand for safe nonsteroidal options [30] - **Treatment Guidelines**: Current AAD treatment guidelines are outdated, but dermatologists are adapting to new therapies independently [39][41] - **Long-term Efficacy**: Long-term studies indicate no decrease in efficacy for XEREVE, with improved patient outcomes over time [78][79] This summary encapsulates the key points discussed during the Arcutis Biotherapeutics FY Conference Call, providing insights into the company's current status, growth strategies, and market dynamics.

Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]

Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]

Group 1 - The article emphasizes the importance of proof of concepts or product market fits in biotech investments to mitigate regulatory and approval risks while gauging market responses [1] - The author has over 20 years of experience in quantitative research, financial modeling, and risk management, focusing on equity valuation, market trends, and portfolio optimization [1] - The investment research is co-authored with a partner, combining strengths to deliver high-quality, data-driven insights, with a focus on macroeconomic trends, corporate earnings, and financial statement analysis [1]

WESTLAKE VILLAGE, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in the Goldman Sachs 46th Annual Global Healthcare Conference, taking place June 9-11, 2025. Details for the company’s participation are as follows: Fireside Chat Date: Tuesday, June 10, 2025 Fireside Chat Time: 4:00 pm EDT The webcast f ...