Arcutis Biotherapeutics (ARQT) Presents Positive Phase 2 Data for ZORYVE Cream in Infants

Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) is one of the 10 Overlooked Growth Stocks to Buy Now.

Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) is one of the overlooked growth stocks to buy now. On March 28, Arcutis Biotherapeutics presented new Phase 2 data from its INTEGUMENT-INFANT trial at the 2026 American Academy of Dermatology Annual Meeting. The study evaluated ZORYVE (roflumilast) cream 0.05% in infants aged 3 to 24 months with mild to moderate atopic dermatitis. Results showed the once-daily, non-steroidal treatment was well tolerated and improved skin clearance, with ~half of the participants achieving Clear or Almost Clear status after 4 weeks of treatment.

A standout finding from the study was the rapid relief of itch, a primary distress factor for infants and their families. Caregivers reported visible improvements in scratching and itching in as little as 10 minutes for ~47% of the infants. Furthermore, the cream showed high efficacy in treating sensitive areas like the scalp, with 67.5% of affected infants reaching Clear or Almost Clear scalp ratings by the end of the month-long study.

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The safety profile remained consistent with previous pediatric trials, showing minimal application site irritation and no serious adverse events. Based on these outcomes, Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) plans to submit a supplemental NDA to the FDA in Q2 2026. If approved, this would expand the ZORYVE portfolio (which already includes formulations for plaque psoriasis and seborrheic dermatitis) to provide a targeted, long-term topical option for the most vulnerable pediatric populations.

Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) develops and commercializes treatments for dermatological diseases. Its lead product is a topical roflumilast cream for plaque psoriasis & atopic dermatitis, called ZORYVE.

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