Business
Arcutis Announces Second Quarter 2021 Financial Results and Provides Business Update
Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Anticipates submission of a New Drug Application (NDA) for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic dermatitis, a disease that affects more than 10 million people in the U.S.Anticipates initiation of single pivotal Phase 3 trial of topical roflumilast foam in scalp psoriasis in Q3 2021Enrolling pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitisStrong financial position with over $400 million in cash, cash equivalents, and marketable securities providing cash runway well into 2023 WESTLAKE VILLAGE, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, or immuno-dermatology, today reported financial results for the quarter ended June 30, 2021, and provided a business update. “We are on track to submit our plaque psoriasis NDA to the FDA soon, based on the strongly positive pivotal Phase 3 results reported in February. We have also initiated, or are on the cusp of initiating, three more Phase 3 programs of topical roflumilast, with multiple top-line readouts in 2022,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We continue to add top talent to our team, as our strong financial position allows us to build out key capabilities to ensure we are ready to launch topical roflumilast, pending FDA approval, and to maximize the potential of our medicines for patients, dermatologists, and shareholders. The significant progress made at Arcutis in the first half of 2021 positions us well for an exciting next 18 months.” Pipeline Updates 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. Arcutis anticipates submitting an NDA for plaque psoriasis to the U.S. Food and Drug Administration (FDA) late in the third quarter or early in the fourth quarter of 2021, based on the positive results from two pivotal Phase 3 clinical ...