Arcutis Biotherapeutics, Inc. (ARQT) Eyes Pediatric Expansion for ZORYVE Cream

In this article, we will be taking a look at the 11 Best Performing Biotech Stocks So Far in 2025. Arcutis Biotherapeutics, Inc. stands ninth among them.

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is strengthening its position in dermatology with ZORYVE, a novel, steroid-free PDE4 inhibitor available in cream and foam formulations for immune-mediated skin conditions such as plaque psoriasis, seborrheic dermatitis, and atopic dermatitis.

In 2025, the company achieved key milestones. In May, the FDA approved ZORYVE foam 0.3% for treating plaque psoriasis in adults and adolescents, including scalp and other hair-bearing areas that are often difficult to manage. This approval addressed significant treatment gaps and highlighted the drug’s strong efficacy profile. In September, Arcutis filed a supplemental New Drug Application seeking to expand ZORYVE cream’s label to include children as young as two years old with plaque psoriasis. If approved, it would become the only topical PDE4 inhibitor available for this pediatric population, offering a safe alternative to steroids and addressing a critical unmet need.

This progress has contributed to ARQT emerging among the best performing stocks in the healthcare sector, reflecting strong clinical execution and market potential. Another major decision looms in October, when the FDA is set to rule on ZORYVE cream 0.05% for atopic dermatitis in children aged two to five. Positive results could make it the first PDE4 topical option for young atopic dermatitis patients, further broadening Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT)’s footprint in pediatric dermatology.

Clinical studies have shown ZORYVE provides rapid itch relief and significant skin clearance across age groups while maintaining a favorable safety profile. Beyond ZORYVE, Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is advancing a late-stage pipeline that includes a topical JAK inhibitor for alopecia areata and a novel CD200R agonist (ARQ-234) for atopic dermatitis, signaling long-term growth potential.

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