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Stock impact report

Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.05% Show Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Children Aged 2 to 5 with ...

Arcutis Biotherapeutics, Inc. - Common stock (ARQT) 
Company Research Source: GlobeNewswire
Long-term safety and tolerability profile consistent with pivotal data in atopic dermatitis (AD), with no new safety signals observed during 56 weeks of treatmentResults from open-label extension study highlight that 71.9% of patients who rolled over from the roflumilast cream treatment arm in INTEGUMENT-PED achieved EASI-75 at Week 56Arcutis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025 for roflumilast cream 0.05% WESTLAKE VILLAGE, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced results from the INTEGUMENT-OLE long-term open-label study of once-daily roflumilast cream 0.05% demonstrating the durable efficacy and favorable safety profile of roflumilast cream 0.05% in the treatment of mild to moderate AD in children 2 to 5 year Show less Read more
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