Arcutis Biotherapeutics stock rises on FDA acceptance of pediatric psoriasis drug

Investing.com -- Arcutis Biotherapeutics Inc (NASDAQ:ARQT) stock rose 4.5% on Monday after the FDA accepted the company’s application to expand the use of its psoriasis treatment to younger children.

The regulatory agency set a target action date of June 29, 2026, for the supplemental New Drug Application (sNDA) for ZORYVE cream 0.3%. If approved, the once-daily topical phosphodiesterase-4 (PDE4) inhibitor would become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 years old.

ZORYVE is currently approved for plaque psoriasis in adults and children down to age 6. The company’s application to expand the drug’s use to younger children is supported by data from a 4-week Maximal Usage Systemic Exposure study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study.

"This milestone brings us closer to helping families and clinicians caring for young children with plaque psoriasis," said Frank Watanabe, president and CEO of Arcutis. "If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for children as young as two, offering a steroid-free option that delivers both efficacy and tolerability for this particularly vulnerable group."

The Westlake Village, California-based company focuses on developing treatments for immune-mediated skin diseases. Results from the long-term study demonstrated consistent favorable safety and tolerability as well as persistence of efficacy across all age ranges studied.

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