Business
Arcutis Announces Third Quarter 2020 Financial Results and Provides Business Update
Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Pivotal Phase 3 data in plaque psoriasis anticipated in first quarter of 2021Pivotal Phase 3 trials in atopic dermatitis anticipated to begin in late 2020 or early 2021Recent positive Phase 2 data in seborrheic dermatitis supports pipeline advancement in indication that impacts 10 million patients in the U.S.Strong financial position with over $300 million in cash, cash equivalents and marketable securities including the proceeds from our recent equity offering, providing cash runway into 2022 WESTLAKE VILLAGE, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today reported financial results for the quarter ended September 30, 2020, and provided a business update.\n “Arcutis is rapidly advancing an innovative and differentiated late-stage pipeline of potential best-in-class topical dermatology therapies, with five important clinical data readouts anticipated by mid-2021,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We expect to report topline data from our pivotal Phase 3 trials evaluating roflumilast cream as a potential once daily topical treatment for plaque psoriasis in the first quarter of next year and, if positive, anticipate submission of our New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of 2021. If approved, we believe roflumilast cream has the potential to eliminate the need for dermatologists and patients to compromise between efficacy and safety. Our focus on addressing the gap in dermatology drug development currently includes four product candidates in development for seven indications, with an addressable U.S. market of over 20 million patients.” Pipeline Update ARQ-151 (topical roflumilast cream) - a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a cream formulation, being developed as a potential treatment for plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. Completed enrollment in the two on-going pivotal Phase 3 clinical trials (DERMIS-1 and-2) in patients with plaque psoriasis, with topline data anticipated in the first quarter of 2021.On-going Phase 2 long-term safety stud...