FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over
Arcutis Biotherapeutics, Inc. - Common stock (ARQT)
Company Research
Source: GlobeNewswire
U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpSupplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA has accepted its sNDA for ZORYVE (roflumilast) foam 0.3%, a once-daily, next generation phosphodiesterase-4 (PDE4) inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis. The FDA assigned the application a PDUFA target action date of May 22, 2025. “In clinical studies, investigat
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News
- New Data Shows ZORYVE® (Roflumilast) Cream 0.15% Provided Consistent Improvement of Atopic Dermatitis in Individuals With Diverse Skin TypesGlobeNewswire
- Arcutis Announces Publication of ZORYVE® (roflumilast) Cream 0.15% Pivotal Results from Phase 3 INTEGUMENT-1 and -2 Trials in Mild to Moderate Atopic Dermatitis in Journal of American Medical Association DermatologyGlobeNewswire
- Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Arcutis Completes Enrollment of Phase 1b Alopecia Areata Study Evaluating ARQ-255GlobeNewswire
- 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 Mild to Moderate Atopic DermatitisGlobeNewswire
ARQT
Earnings
- 8/14/24 - Beat
ARQT
Sec Filings
- 9/25/24 - Form 4
- 9/24/24 - Form 144
- 9/5/24 - Form 4
- ARQT's page on the SEC website