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. (Nasdaq: ARQT) is a commercial-stage medical dermatology company based in Westlake Village, California, specializing in developing and commercializing treatments for dermatological diseases. Founded in 2016, Arcutis leverages recent advances in immunology and inflammation to create differentiated therapies targeting immune-mediated dermatological conditions.
Arcutis' lead product, ZORYVE (roflumilast) cream, is a topical treatment for plaque psoriasis and atopic dermatitis. The company has recently launched ZORYVE topical foam for seborrheic dermatitis and scalp psoriasis. Both formulations utilize roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor that has shown significant improvement in clinical trials.
Arcutis is also advancing its pipeline with ARQ-252, a selective topical small molecule inhibitor of janus kinase type 1 for hand eczema, and ARQ-255 for alopecia areata. The company champions meaningful innovation to address the urgent needs of patients living with chronic, immune-mediated skin conditions, aiming to improve treatment options and patient outcomes.
In recent developments, Arcutis has been actively participating in industry conferences, securing strategic collaborations, and expanding its workforce. The company's financial health is robust, with a strong cash position bolstered by a recent public offering and a strategic licensing agreement in Japan. Arcutis continues to focus on long-term growth and innovation, with multiple ongoing clinical programs targeting various inflammatory dermatological conditions.
For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the advancement of its topical roflumilast foam (ARQ-154) into Phase 3 development for treating seborrheic dermatitis, following a successful End-of-Phase 2 meeting with the FDA. This pivotal trial is expected to start in Q2 or Q3 2021. Roflumilast foam has shown statistically significant improvement in clinical trials and possesses a favorable safety profile. Affecting over 10 million patients in the U.S., seborrheic dermatitis presents a significant market opportunity for this treatment, which could become a new standard of care.
Arcutis Biotherapeutics (Nasdaq: ARQT) has initiated pivotal Phase 3 clinical trials for its topical roflumilast cream aimed at treating atopic dermatitis (AD), which affects around 19 million people in the U.S. The trials, dubbed INTEGUMENT-1 and INTEGUMENT-2, will involve approximately 1,300 participants. Roflumilast cream is designed to be a once-daily, nonsteroidal treatment, offering a potential breakthrough in safety and efficacy for AD patients, particularly children. Topline data is anticipated in the second half of 2022, with a third study planned for younger patients.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the appointment of Matthew Moore as Chief Business Officer. With over 20 years in the biopharmaceutical industry, Moore previously led business development at Allergan’s Medical Aesthetics unit, generating over $4 billion. His addition is expected to strengthen Arcutis’ strategy in dermatology, enhancing shareholder value. Arcutis focuses on unmet needs in immuno-dermatology and is advancing four drug candidates to improve treatment for conditions like plaque psoriasis and atopic dermatitis.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has been added to the NASDAQ Biotechnology Index effective December 21, 2020. This inclusion, based on criteria such as market capitalization and trading volume, aligns Arcutis with prominent biotech entities, enhancing its visibility and credibility in the market. As a late-stage biopharmaceutical company, Arcutis specializes in developing treatments for immune-mediated dermatological conditions, with a robust pipeline of four novel drug candidates, including topical roflumilast aimed at addressing multiple skin disorders.
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.
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