Business
Arcutis Announces Third Quarter 2021 Financial Results and Provides Business Update
Submitted New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of diseaseInitiated single pivotal
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Submitted New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis across the full spectrum of diseaseInitiated single pivotal Phase 3 trial of roflumilast foam in scalp and body psoriasisEnrolling pivotal Phase 3 trials of roflumilast cream in atopic dermatitis and roflumilast foam in seborrheic dermatitisExpanded patent portfolio with issuance of first pharmacokinetics patent covering both the cream and foam formulations of topical roflumilastStrong financial position with approximately $370 million in cash, cash equivalents, and marketable securities, providing cash runway well into 2023 WESTLAKE VILLAGE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today reported financial results for the quarter ended September 30, 2021, and provided a business update. “The submission of our first NDA for roflumilast cream represents a pivotal milestone for the Arcutis team and for the millions of individuals struggling with plaque psoriasis. It also demonstrates Arcutis' progress to simplify complex disease management and solve the most persistent challenges of treating chronic inflammatory diseases of the skin,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “With our proven, experienced team, our strong financial position, and our expanded intellectual property estate, we continue to invest in our ability to maximize the potential of our medicines for patients, dermatologists, and shareholders. We look forward to a transformative 2022 for Arcutis, with a potential launch in plaque psoriasis and three additional Phase 3 clinical data readouts anticipated.” Pipeline Updates Roflumilast cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a cream formulation, being developed as a potential treatment for plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis In late September, Arcutis submitted an NDA for plaque psoriasis to the U.S. Food and Drug Administration (FDA), supported by the positive results from two pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2).Patient enrollment continue...