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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 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.
Arcutis Biotherapeutics (Nasdaq: ARQT) will participate in the Wedbush PacGrow Healthcare Conference on August 12, 2020, at 10:10 a.m. PT / 1:10 p.m. ET. The presentation will be available via webcast on Arcutis' website, with an archived replay accessible for 30 days post-conference. Arcutis focuses on developing treatments for immune-mediated dermatological diseases, using advancements in immunology to tackle significant challenges. Their lead candidate, topical roflumilast, aims to improve care for conditions like plaque psoriasis and atopic dermatitis.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive results from a Phase 1/2a trial of its topical roflumilast cream for chronic plaque psoriasis. The cream demonstrated safety and efficacy at 0.5% and 0.15% doses, indicating a potential new treatment option. According to the study, 66%-67% improvement was observed at week 4 versus 38% for the vehicle. Roflumilast cream showed favorable tolerability, with no patient discontinuations due to adverse events. Arcutis plans to release Phase 3 topline data in H1 2021, further solidifying its position in the dermatological treatment market.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced positive results from a Phase 2b trial of its topical roflumilast cream for chronic plaque psoriasis, published in The New England Journal of Medicine. The study demonstrated a significant improvement in psoriasis symptoms, with 28% of patients achieving clear or almost clear skin at week six. Roflumilast cream was well-tolerated, with adverse events primarily mild. The company is conducting Phase 3 trials, with topline data expected in early 2021, marking a potential breakthrough for patients needing new treatment options.
Arcutis Biotherapeutics (Nasdaq: ARQT) has commenced enrollment in the Phase 2b study of ARQ-252, a selective topical JAK1 inhibitor, targeting chronic hand eczema. This condition affects over 8 million people in the U.S., often leading to significant discomfort and disruption in daily life. The trial aims to evaluate the safety and efficacy of ARQ-252 in adult patients. Topline data is anticipated in the second half of 2021, highlighting the potential of ARQ-252 to provide effective treatment without the adverse effects associated with less selective JAK inhibitors.
Arcutis Biotherapeutics (Nasdaq: ARQT) has enrolled its first patient in a long-term safety study of roflumilast foam, a potential best in class topical treatment for seborrheic dermatitis. Affecting over 6 million Americans, this chronic skin condition necessitates innovative non-steroidal therapies. The company anticipates topline data from its Phase 2 trial by early Q4 2020, focusing on the foam's safety and efficacy. Roflumilast foam could provide a novel solution where traditional treatments fail.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced that President and CEO Frank Watanabe will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference from June 9-11, 2020. Watanabe's presentation is scheduled for June 11, 2020, at 11:10 a.m. PT / 2:10 p.m. ET. The event will be webcast, accessible on the company's website, and an archived replay will be available for 30 days post-conference. Arcutis focuses on developing treatments for immune-mediated dermatological diseases, with ongoing projects that aim to address significant unmet medical needs in this area.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced the appointment of Ayisha Jeter as the new Vice President of Market Access. Jeter brings 18 years of experience in the biopharmaceutical industry, focusing on market access strategies. Her past roles include Vice President at Assertio and Associate Director at Purdue Pharma. This strategic hire is part of Arcutis' preparation for the potential commercialization of its product candidates aimed at treating immune-mediated dermatological conditions. Arcutis aims to evolve into a fully-integrated commercial-stage dermatology company.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has appointed Jay Ramsinghani as Vice President of Commercial Strategy and Operations, as announced on May 27, 2020. With over 18 years of experience in the biopharmaceutical sector, particularly in dermatology, Ramsinghani will lead Arcutis' commercial operations as the company moves towards potential product commercialization. Previously, he held senior roles at Alastin and Kythera Biopharmaceuticals. Arcutis is focused on developing innovative treatments for immune-mediated dermatological diseases, with several novel compounds in the pipeline.