Arcutis draws focus to Zoryve data, FDA filings and Q4 expectations

Arcutis Biotherapeutics is back in focus after new Phase 3 extension data for ZORYVE cream 0.05% in young children with mild-to-moderate atopic dermatitis was published in Pediatric Dermatology. The company is scheduled to report fourth-quarter and full-year 2025 results on Feb. 25, after market close, with the consensus estimate for fourth-quarter revenues pegged at $115.7 million and the same for earnings pinned at 3 cents.

Arcutis Biotherapeutics primarily derives product revenues from the sale of its flagship product, Zoryve (topical roflumilast), a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor marketed in the United States in both cream and foam formulations. ARQT has been witnessing consistent growth in product sales from Zoryve, driven by sustained increases in prescription volumes across all approved indications, including plaque psoriasis, atopic dermatitis and seborrheic dermatitis, along with improved gross-to-net pricing. The launch of Zoryve foam 0.3% for plaque psoriasis of the scalp and body boosted sales in the third quarter.

In October, the FDA approved Zoryve cream 0.05% for mild to moderate atopic dermatitis in children aged two to five years. The FDA accepted Arcutis’s supplemental new drug application seeking approval for Zoryve cream 0.3% for treating plaque psoriasis in children aged two to five years in November, and the authority has set a target action date of June 29, 2026.

Arcutis Biotherapeutics completed enrollment in an ongoing mid-stage study evaluating Zoryve cream 0.05% in infants aged three months to under 24 months with mild to moderate atopic dermatitis in November, with top-line data expected in the first quarter of 2026. Beyond its currently approved indications, Arcutis is advancing clinical programs to broaden Zoryve’s label into additional indications. The company has initiated patient enrollment in mid-stage studies with Zoryve foam 0.3% for vitiligo, as well as hidradenitis suppurativa.

Fourth-quarter 2025 selling, general, and administrative expenses are expected to have increased, reflecting continued investments to support the ongoing commercial rollout of Zoryve. Over the past year, shares of Arcutis Biotherapeutics have rallied 106.6% compared with the industry’s growth of 18.8%.

Arcutis has maintained an earnings surprise track record so far. The bottom line surpassed estimates in each of the trailing four quarters, delivering an average surprise of 64.80%, and in the last reported quarter, the company delivered an earnings surprise of 160%.