Welcome to our dedicated page for Arcutis Biotherapeutics news (Ticker: ARQT), a resource for investors and traders seeking the latest updates and insights on Arcutis Biotherapeutics stock.
Arcutis Biotherapeutics, Inc. (ARQT) is a leader in developing innovative topical therapies for immune-mediated skin conditions. This page provides investors and medical professionals with essential updates on FDA approvals, clinical trial progress, and strategic initiatives shaping the future of dermatological care.
Access authoritative information about ARQT's non-steroidal treatments for conditions including atopic dermatitis and plaque psoriasis. Our curated news collection features regulatory milestones, research developments, and market analyses to help stakeholders track the company's progress in addressing unmet medical needs.
Key updates include new product launches, clinical trial results, partnership announcements, and scientific presentations. All content is verified through primary sources to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to Arcutis' latest advancements in immuno-dermatology. Check regularly for updates on pipeline developments and peer-reviewed research findings that demonstrate the company's commitment to transforming skin disease treatment.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced significant progress in its immuno-dermatology platform during its Virtual Investor Day on December 9, 2020. The company showcases a robust pipeline with 4 development programs targeting 7 dermatological diseases, including Phase 2 and Phase 3 initiatives. Potential U.S. market sales could reach $3 billion to $8 billion by 2030. Key products include topical roflumilast for conditions like psoriasis and atopic dermatitis, demonstrating strong safety and efficacy. The company aims to leverage its innovative strategies and continued clinical advancements.
Arcutis Biotherapeutics has completed the 8-week treatment period for its pivotal Phase 3 clinical trials, DERMIS-1 and DERMIS-2, evaluating ARQ-151 (topical roflumilast cream) for plaque psoriasis. Approximately 8.6 million U.S. patients suffer from this condition. Topline data is expected in Q1 2021, with a potential NDA submission to the FDA by year-end. The cream is positioned as a ‘Best in Class’ topical PDE4 inhibitor, promising enhanced outcomes without compromising safety. Previous Phase 2 studies support its chronic use.
Arcutis Biotherapeutics (Nasdaq: ARQT) will host a virtual Investor Day on December 9, 2020, from 11:00 AM to 1:00 PM EST. The event will highlight the company's innovative immune-dermatology product development platform and its promising pipeline of drug candidates aimed at treating various skin conditions. Presentations will include insights from Arcutis' Senior Leadership Team and dermatologist Zoe Diana Draelos, M.D. Registration for the event is available online, and a live audio webcast will be accessible on the Investor Relations section of the Arcutis website.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) reported positive outcomes from a long-term safety study of its ARQ-151 topical cream for treating plaque psoriasis. The study demonstrated favorable safety and tolerability, with only 3.6% of patients experiencing treatment-related adverse events over a span of 52 to 64 weeks. Notably, 44.8% of subjects achieved an Investigator Global Assessment (IGA) of clear or almost clear at week 52. The company anticipates pivotal Phase 3 data in Q1 2021, bolstering its commitment to develop effective therapies for unmet dermatological needs.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive results from its Phase 2b trial of roflumilast foam for scalp psoriasis, demonstrating significant improvement on primary and secondary endpoints. The foam showed a 59.1% success rate on the primary endpoint versus 11.4% for the vehicle (p<0.0001). Additionally, 71% of participants experienced meaningful itch reduction. The safety profile was favorable, with low discontinuation rates. With approximately 40% of psoriasis patients affected by scalp involvement, roflumilast foam is positioned as a potential 'Best in Class' treatment option.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced that CEO Frank Watanabe will present a corporate overview at the Stifel 2020 Virtual Healthcare Conference on November 18, 2020 at 12:20 p.m. PST. The presentation will focus on Arcutis’ developments in immuno-dermatology, highlighting its innovative therapies targeting unmet needs in skin diseases. The event will be webcast, accessible via Arcutis’ website, with a replay available for 30 days post-conference. Arcutis is advancing treatments for conditions such as plaque psoriasis and atopic dermatitis.
Arcutis Biotherapeutics (Nasdaq: ARQT) reported third-quarter results on November 5, 2020, revealing a net loss of $38.2 million, equating to $1.01 per share. The company holds over $300 million in cash and equivalents, ensuring operational funding into 2022. Upcoming pivotal Phase 3 data for roflumilast cream in plaque psoriasis is expected in Q1 2021. Positive Phase 2 data for seborrheic dermatitis strengthens its pipeline, targeting a market of over 20 million patients in the U.S. R&D expenses surged to $32.7 million, largely due to new clinical trials.
Arcutis Biotherapeutics (Nasdaq: ARQT) has appointed Terrie Curran to its Board of Directors, effective Nov. 2, 2020, following the resignation of Alexander Asam. Curran brings over 20 years of experience in biopharmaceuticals and will aid in commercialization as Arcutis prepares for pivotal Phase 3 trial data and potential NDA submission for its lead product, topical roflumilast. This treatment aims to set a new standard for several inflammatory dermatological conditions. The company anticipates growth and innovation under Curran's leadership.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced positive results from its Phase 2 studies of roflumilast cream for plaque psoriasis and atopic dermatitis. The Phase 2b study demonstrated significant reduction in itch severity and related sleep loss, with 63% of patients achieving clinically meaningful itch reduction by week 12. In atopic dermatitis, although the primary endpoint did not reach statistical significance, notable improvements were recorded. Both studies reported roflumilast cream as safe and well-tolerated, supporting its potential as a leading topical treatment option.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive outcomes from Phase 2 studies of roflumilast cream for treating atopic dermatitis and plaque psoriasis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress and other conferences. Two oral presentations and one poster highlighted the cream’s effectiveness in improving itch severity and symptom burden. These findings were presented on October 29 and 31, 2020. The cream is positioned as a promising 'Best in Class' topical PDE4 inhibitor, addressing significant dermatological treatment gaps.
