FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5
Arcutis Biotherapeutics, Inc. - Common stock (ARQT)
Company Research
Source: GlobeNewswire
Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old. The FDA has set a PDUFA target action date of June 29, 2026, for this application. “Plaque psoriasis in young children can be particularly challenging to manage, as it often affects sensitive areas such as the face and intertriginous skin,” said Amy P
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- Arcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis [Yahoo! Finance]Yahoo! Finance
- Arcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic DermatitisGlobeNewswire
ARQT
Earnings
- 10/28/25 - Beat
ARQT
Sec Filings
- 12/3/25 - Form 4
- 12/3/25 - Form 4
- 12/1/25 - Form 144
- ARQT's page on the SEC website