Arcutis Biotherapeutics, Inc. (ARQT), a commercial-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2.
Notably, with this seventh FDA approval for ZORYVE, ZORYVE cream 0.3% becomes the first once-daily, non-steroidal topical therapy approved for children with plaque psoriasis as young as 2 years of age, according to the company.
Psoriasis is a common, chronic, inflammatory skin disease that affects an estimated 9 million people in the United States.
ZORYVE cream 0.3% is a once-daily, steroid-free topical that can be used anywhere on the body, including intertriginous areas, with no duration limit.
ZORYVE cream 0.3% was previously approved for the treatment of plaque psoriasis in adults and children as young as 6 years old.
The approval of the expanded indication is based on data from a 4-week Maximal Usage Systemic Exposure (MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to 5 years with plaque psoriasis.
In clinical studies, ZORYVE cream 0.3% demonstrated consistent safety and efficacy in improving the signs and symptoms of plaque psoriasis as seen in adults and adolescents, and was safe and well tolerated in children as young as age 2.
Supportive long-term safety data were also derived from an open-label extension study (ARQ-151-306), which evaluated the long-term safety, tolerability, and efficacy for up to 24 weeks of treatment.
In the first quarter of 2026, ZORYVE (roflumilast) sales were $105.39 million, a 65% increase from $63.85 million in the prior year.
In specific, revenues for the first quarter were $32.7 million for ZORYVE (roflumilast) cream 0.3%, $49.6 million for ZORYVE (roflumilast) topical foam 0.3%, $21.7 million for ZORYVE (roflumilast) cream 0.15%, and $1.4 million for ZORYVE (roflumilast) cream 0.05%.
ARQT has traded between $13.06 and $31.77 over the last year. The stock closed Monday's trade at $26.76, down 0.89%.
In the overnight market, ARQT is up 2.35% at $27.39.
For More Such Biotech Stock News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Economic News
What parts of the world are seeing the best (and worst) economic performances lately? Click here to check out our Econ Scorecard and find out! See up-to-the-moment rankings for the best and worst performers in GDP, unemployment rate, inflation and much more.
September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.