Arcutis projects ZORYVE sales of $455-470 million for 2026

Arcutis Biotherapeutics Inc. (NASDAQ: ARQT) announced its strategic priorities for 2026, projecting net product sales of $455-470 million for its ZORYVE (roflumilast) franchise.

The company plans to expand its dermatology sales force by approximately 20% to increase prescriber targeting and adoption of ZORYVE, which is approved for treating plaque psoriasis, seborrheic dermatitis, and atopic dermatitis in various age groups.

Arcutis expects to announce results from its INTEGUMENT-INFANT Phase 2 study of ZORYVE cream 0.05% in infants aged 3 months to less than 24 months in the first quarter of 2026, with a supplemental New Drug Application submission planned for the third quarter. The FDA is currently reviewing a supplemental application for ZORYVE cream 0.3% for plaque psoriasis treatment in children ages 2-5, with a target action date of June 29, 2026.

The company is conducting Phase 2 proof-of-concept trials for ZORYVE in vitiligo and hidradenitis suppurativa. Results for the vitiligo program are expected in the fourth quarter of 2026, while hidradenitis suppurativa program advancement decisions are anticipated in the first quarter of 2027.

Arcutis plans to begin enrolling patients in a Phase 1 study of ARQ-234, a fusion protein checkpoint agonist being developed as a biologic treatment for atopic dermatitis, in the first quarter of 2026.

"With strong operating leverage, we are well positioned to pursue new opportunities and reinforce our leadership in medical dermatology drug development and commercialization," said Frank Watanabe, president and chief executive officer, according to the company's announcement.

The company stated it has transitioned to positive cash flows, enabling investment in both ZORYVE franchise growth and pipeline advancement.

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