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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 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.
Arcutis Biotherapeutics has completed enrollment in its Phase 1/2b study of ARQ-252, a selective JAK1 inhibitor aimed at treating chronic hand eczema, a condition affecting over 8 million Americans. The trial's topline data is expected by mid-2021. ARQ-252's high selectivity for JAK1 may provide efficacy while minimizing side effects associated with other JAK inhibitors. The study involved 223 subjects assessing the safety and efficacy of different concentrations of the ARQ-252 cream. This research highlights the company's commitment to addressing the unmet needs in dermatological therapies.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the completion of a public offering of 4,000,000 shares at $25.00 per share, raising gross proceeds of $100 million. Additionally, a private placement of 1,400,000 shares was made to OrbiMed Advisors, generating another $35 million. The offering's registration statement became effective on October 1, 2020. Goldman Sachs, Cowen, and Guggenheim are managing the public offering. Arcutis focuses on developing treatments for immune-mediated dermatological diseases, with its lead candidate targeting plaque psoriasis and other skin conditions.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced a public offering of 4,000,000 shares at $25.00 each, aiming for gross proceeds of $100 million. The offering includes a 30-day option for underwriters to purchase an additional 600,000 shares. Concurrently, Arcutis plans a private placement of 1,400,000 shares at the same price for gross proceeds of $35 million, contingent on the public offering's success. The public offering is expected to close on October 6, 2020. The company focuses on immuno-dermatology treatments and has a developing pipeline of therapies.
Arcutis Biotherapeutics (Nasdaq: ARQT) has completed enrollment in two pivotal Phase 3 trials (DERMIS-1 and DERMIS-2) for its topical roflumilast cream, a potential treatment for plaque psoriasis affecting about 8.6 million patients in the U.S. Topline results are expected in Q1 2021, with a New Drug Application (NDA) submission planned by year-end. Previous Phase 2 studies indicated significant improvements and a favorable safety profile for roflumilast. The cream's unique formulation aims to provide effective treatment without the trade-offs seen in existing therapies.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced its participation in the Cantor Fitzgerald Global Healthcare Conference 2020. The fireside chat presentation is scheduled for September 17, 2020, at 7:40 a.m. PT / 10:40 a.m. ET. This event focuses on the company’s developments in immune-mediated dermatological diseases. Interested parties can access the webcast through the company’s website, which will be available for replay for 30 days following the conference. Arcutis is committed to addressing unmet needs with its innovative therapies for dermatological conditions.
Arcutis Biotherapeutics has announced the advancement of its topical roflumilast cream to Phase 3 clinical trials for atopic dermatitis without conducting a Phase 2b trial following FDA discussions. Roflumilast cream, a selective PDE4 inhibitor, aims to offer a once-daily treatment option for approximately 20 million U.S. patients. Previous trials indicated its efficacy and tolerability are comparable to existing treatments. Topline data for plaque psoriasis trials is expected in early 2021, marking a significant step in developing innovative therapies for dermatological conditions.
Arcutis Biotherapeutics (Nasdaq: ARQT) reported its Q2 2020 financial results, revealing a strong cash position of $224 million. The company anticipates six key clinical data readouts, including pivotal Phase 3 trials for topical roflumilast cream for plaque psoriasis by 2021. R&D expenses surged to $30 million, compared to $7.2 million last year, reflecting ongoing clinical trials. The net loss for Q2 was $35.4 million, or $0.94 per share. Despite rising losses, the firm remains focused on addressing dermatological diseases affecting over 20 million U.S. patients.
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