10:41 AM EST, 11/17/2025 (MT Newswires) -- Arcutis Biotherapeutics ( ARQT ) said Monday the US Food and Drug Administration has accepted its supplemental new drug application to expand the use of Zoryve (roflumilast) cream 0.3% to treat plaque psoriasis to include children ages two to five.

The cream is currently approved for adults and children as young as six, the company said, adding that the FDA has set a target action date of June 29, 2026.

The application is supported by a four-week study in children aged 2 to 5 years with plaque psoriasis and a long-term study, which demonstrated favorable safety and tolerability as well as efficacy across all age ranges, the company said.

Shares of Arcutis Biotherapeutics ( ARQT ) were 3.9% higher in recent trading.

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