Business
Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Received U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis in
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Received U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adults and adolescentsCompleted enrollment of the sole pivotal Phase 3 trial of roflumilast foam in seborrheic dermatitisEnrolling pivotal Phase 3 trials of roflumilast cream in atopic dermatitis and roflumilast foam in scalp and body psoriasisSecured $225 million in non-dilutive debt financing from SLR Capital Partners, further strengthening the balance sheet at an attractive cost of capital and extending cash runway into 2024Strong financial position with more than $385 million in cash, cash equivalents, and marketable securities WESTLAKE VILLAGE, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2021, and provided a business update. “We executed exceptionally well in 2021, delivering strong Phase 3 plaque psoriasis data, initiating three additional Phase 3 programs, and commencing our commercialization efforts. We then capped off the year by receiving FDA acceptance of our NDA filing for roflumilast cream in plaque psoriasis and securing a $225 million non-dilutive loan facility to extend our cash runway into 2024,” said Frank Watanabe, Arcutis’ President and Chief Executive Officer. “We have strong momentum and expect that 2022 will be a transformational year for Arcutis, as we prepare for our first potential product launch in plaque psoriasis and progress our three additional Phase 3 topical roflumilast programs, as well as our early pipeline. With the strong team we have built and our financial flexibility enhanced, we can continue to appropriately invest in our mission to advance the treatment of chronic inflammatory skin diseases for patients and healthcare professionals.” Pipeline Updates Roflumilast cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, being developed as a potential treatment for plaque psoriasis and atopic dermatitis In December 2021, the FDA accepted Arcutis' NDA for plaque psoriasis in adults and adolescents and assigned a target action date of July 29, 2022.In December 20...