Arcutis Biotherapeutics (ARQT) announced the submission of a supplemental New Drug Application to the FDA seeking to expand the indication for ZORYVE cream 0.05% to include the topical treatment of mild to moderate atopic dermatitis in infants down to 3 months. The sNDA is supported by positive results from a Phase 1 open-label pharmacokinetic trial and a Phase 2 open-label trial.
Frank Watanabe, CEO ofArcutis, said: "This potential age expansion supports our strategy to broaden ZORYVEs reach and reinforces its role as a foundational therapy across age groups."
In pre-market trading on NasdaqGS, Arcutis shares are up 1.03 percent to $23.50.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.