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 ...

罗氟司特是一种磷酸二酯酶-4（PDE4）抑制剂，抑制PDE4可减轻炎症反应。0.3%罗氟司特泡沫已分别 于2023年12月和2024年10月在美国和加拿大获批，用于9岁及以上脂溢性皮炎患者局部治疗，这是美国 食品药品监督管理局（FDA）二十多年来首个批准的具有新作用机制的脂溢性皮炎外用药物，在缓解关 键症状和体征方面疗效显著，安全性和耐受性良好。此外，该产品于2025年5月获美国FDA批准用于12 岁及以上头皮和身体银屑病患者的局部治疗。 在国内，0.15%罗氟司特乳膏和0.3%罗氟司特乳膏的相关Ⅲ期临床研究均已于2024年11月完成首例受试 者入组及给药。 本报讯 （记者邬霁霞见习记者王楠）6月11日，华东医药股份有限公司（以下简称"华东医药"）发布公 告称，其全资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收到国家药品监督管理局 （NMPA）核准签发的一项《药物临床试验批准通知书》，批准其申报的0.3%罗氟司特泡沫 （ZORYVE®）开展针对脂溢性皮炎的Ⅲ期临床试验，用于评估该药物的有效性与安全性。 罗氟司特泡沫是中美华东于2023年8月与美国ArcutisBiotherapeutics，Inc ...

本报讯 （记者张敏）6月10日晚，华东医药股份有限公司（以下简称"华东医药"）发布的公告显示，公司全资子公司杭州 中美华东制药有限公司（以下简称"中美华东"）收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知 书》，由中美华东申报的一项评价0.3%罗氟司特泡沫（ZORYVE®）在脂溢性皮炎患者中有效性和安全性的多中心、随机、双 盲、赋形剂平行对照的III期临床试验申请获得批准。 0.3%罗氟司特泡沫（ZORYVE®）已于2023年12月份和2024年10月份分别在美国和加拿大获得药品监管部门批准，用于治 疗9岁及以上脂溢性皮炎患者的局部治疗。该产品是FDA二十多年来首个批准的具有新作用机制的脂溢性皮炎外用药物，有望 为脂溢性皮炎患者带来新的治疗选择。此外，该产品于2025年5月份获得美国食品药品监督管理局（FDA）批准用于12岁及以 上头皮和身体银屑病患者的局部治疗。 公告显示，除罗氟司特泡沫外，其乳膏剂型的研发进展亦持续取得突破。在美国，0.3%罗氟司特乳膏（ZORYVE®）于 2022年7月份获得美国FDA批准，用于治疗12岁及以上患者的斑块状银屑病（包括间擦区域），于2023年10月份获 ...

Core Viewpoint - Huadong Medicine's subsidiary, Zhejiang Zhongmei Huadong Pharmaceutical, received approval for a Phase III clinical trial of 0.3% roflumilast foam (ZORYVE) for seborrheic dermatitis patients, indicating a significant advancement in treatment options for this condition [1][2]. Group 1: Product Development and Clinical Trials - The approved clinical trial targets local treatment for patients aged 9 and above with seborrheic dermatitis, utilizing roflumilast, a PDE4 inhibitor that reduces inflammation [2]. - Roflumilast foam has shown significant efficacy, with nearly 80% of patients achieving complete or near-complete clearance of symptoms by week 8, while maintaining good safety and tolerability [2]. - The product is designed for ease of use, with a once-daily application and no long-term usage restrictions compared to traditional topical corticosteroids [2]. Group 2: Market Potential and Demand - There is a substantial unmet clinical need for effective treatments for seborrheic dermatitis, as existing therapies often have limited efficacy and significant side effects [2]. - The Chinese psoriasis drug market is projected to reach $3.255 billion by 2025, while the global atopic dermatitis treatment market is expected to reach $24.5 billion by 2032, highlighting the market potential for roflumilast [4]. Group 3: Company Strategy and Innovation - Huadong Medicine is focusing on autoimmune diseases, with a comprehensive pipeline that includes over 20 innovative products targeting various conditions, including psoriasis and atopic dermatitis [5]. - The company has established an R&D platform for topical formulations and has built three production lines for external preparations, indicating a strong commitment to innovation in this area [8]. - Huadong Medicine aims to enhance the accessibility of innovative drugs and provide differentiated treatment options, positioning itself for long-term competitive advantage in the autoimmune sector [9].

WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open- label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily o ...

New data from the Phase 3 INTEGUMENT-OLE long-term open label study show durable improvement in the signs and symptoms of atopic dermatitis (AD), including almost half of participants achieving no or minimal itch with ZORYVE cream 0.15% or ZORYVE cream 0.05%New data demonstrate that for children ages 2 to 5 who achieved disease clearance and switched to proactive twice-weekly application of investigational ZORYVE cream 0.05%, the median duration of disease control was 238 daysConsistent efficacy, safety, an ...

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 Viewpoint - Arcutis Biotherapeutics has announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium, aimed at improving the understanding and management of genital psoriasis, which significantly impacts patients' quality of life and interpersonal relationships [1][2][3]. Group 1: Consensus Statements and Guidelines - The consensus statements focus on three key areas: physical diagnosis and patient conversations, impact on quality of life and interpersonal relationships, and treatment decisions [1][2]. - Genital psoriasis affects approximately six million Americans and is often underreported and undertreated due to its sensitive nature [2][4]. - The Consortium's guidelines aim to normalize conversations about genital psoriasis and improve shared decision-making between clinicians and patients [3][5]. Group 2: Research and Methodology - A comprehensive literature review was conducted, analyzing 78 unique publications to formulate the consensus statements [2]. - The consensus was developed using a modified Delphi process, which included virtual meetings and anonymous surveys to gather feedback [2][3]. Group 3: Clinical Implications - Genital psoriasis should be recognized as a distinct diagnosis with a unique ICD-10-CM code to facilitate better diagnosis and treatment [5]. - Early diagnosis is critical, as the psychological burden and symptoms may worsen over time if not addressed promptly [5][10]. - The implementation of standardized assessment tools and comprehensive skin examinations is recommended to improve patient care [5][10]. Group 4: Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a portfolio aimed at addressing immune-mediated dermatological diseases [6]. - The company is committed to developing differentiated therapies and has a robust pipeline for various inflammatory dermatological conditions [6].

May 11, 2025 10:00 PM GMT New Slide Refreshed Slide Key MORGAN STANLEY & CO LLC. Vikram Purohit Equity Analyst vikram.purohit@ms.com +1 212 761-3804 Judah Frommer Equity Analyst judah.frommer@ms.com +1 212 761-1270 Michael Ulz Equity Analyst michael.ulz@ms.com +1 212 761-4650 Maxwell Skor Equity Analyst maxwell.skor@ms.com +1 212 761-4804 Sean Laaman Equity Analyst sean.laaman@ms.com +1 212 761-4947 Terence Flynn Equity Analyst terence.flynn@ms.com +1 212 761-2230 Finger On The Pulse US SMID Cap Biotech Bea ...