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ARQT - FDA accepts Arcutis Bio's new drug application for roflumilast cream for psoriasis
Arcutis Biotherapeutics Inc.
Arcutis Biotherapeutics (NASDAQ:ARQT) announces the FDA's acceptance for review of its new drug application (NDA) for roflumilast cream for psoriasis in adults and adolescents. The FDA assigned a PDUFA target action date of July 29, 2022. Arcutis’ NDA submission is supported by positive data from Phase 3 program (DERMIS 1 and DERMIS 2 study) and a long-term Phase 2b study.