The U.S. Food and Drug Administration accepted a supplemental New Drug Application for ZORYVE® cream 0.3% on November 17 2025, extending the drug’s indication to children aged two to five for the treatment of plaque psoriasis. The agency set a PDUFA target action date of June 29 2026, marking the next milestone in the approval process. If approved, ZORYVE would become the first topical phosphodiesterase‑4 inhibitor licensed for this age group, filling a significant unmet need for steroid‑free therapy in very young patients.
Arcutis Biotherapeutics has been accelerating its commercial momentum in recent quarters. Net product revenue reached $99.2 million in Q3 2025, a 122% year‑over‑year increase, and the company posted a net income of $7.4 million—its first profitable quarter after a $41.5 million loss in Q3 2024. The company’s guidance for 2026 projects net product revenue between $455 million and $470 million, a range that reflects the expected contribution from the expanded pediatric indication and other ZORYVE indications.
Frank Watanabe, President and CEO of Arcutis, said the FDA acceptance “brings us closer to helping families and clinicians caring for young children with plaque psoriasis. 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 statement underscores the strategic importance of the pediatric expansion to the company’s broader goal of becoming a leader in steroid‑free dermatology.
The pediatric psoriasis market is currently limited, with few non‑steroidal options available for children under six. By adding the 2‑5 age group, Arcutis positions ZORYVE as a differentiated product that can capture a share of a niche but growing segment. The move also strengthens the company’s competitive stance against topical steroids and vitamin‑D analogs, which are associated with long‑term safety concerns in young patients.
The expanded indication is expected to drive incremental revenue for Arcutis, contributing to the upper end of its 2026 guidance. The company’s strong cash position and recent profitability give it the financial flexibility to support the additional clinical and regulatory activities required for the pediatric approval. Management’s focus on cost control and operational leverage has helped maintain margins even as revenue grows, positioning the company to capitalize on the new market opportunity.
Investors have responded positively to Arcutis’ recent earnings, with the company’s financial performance and strategic trajectory reinforcing confidence in its growth prospects. The FDA acceptance of the supplemental NDA adds further momentum to the company’s expansion strategy and is likely to be viewed favorably by market participants.
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