Regulatory2026-06-29

ZORYVE (roflumilast) Cream 0.3%

Arcutis Biotherapeutics Inc.ARQT
Indication
Plaque Psoriasis in Children Ages 2 to 5
Stage
phase5
Event
Regulatory Decision
Details

Feb. 25, 2026: Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) reported Q4 and full-year 2025 results and provided regulatory/pipeline updates for ZORYVE (roflumilast) and early programs. ZORYVE Q4 2025 net product revenue was $127.5M (+84% YoY; +29% QoQ) and FY2025 net product revenue was $372.1M (+123% vs 2024). The company raised FY2026 net product revenue guidance to $480M–$495M.

Regulatory/clinical catalysts:

  • ZORYVE cream 0.3% (plaque psoriasis, ages down to 2 years): sNDA accepted; PDUFA target action date June 29, 2026.
  • ZORYVE cream 0.05% (atopic dermatitis, infants 3–24 months): positive topline data from the INTEGUMENT-INFANT Phase 2 trial; sNDA submission expected in Q2 2026.
  • ZORYVE foam 0.3%: ongoing Phase 2 proof-of-concept studies in vitiligo and hidradenitis suppurativa; program advancement decisions expected in Q4 2026 (vitiligo) and Q1 2027 (hidradenitis suppurativa).
  • ARQ-234 (CD200 receptor checkpoint agonist fusion protein; atopic dermatitis): plans to enroll first patient in a Phase 1 study in Q1 2026.

Commercial updates included Medicare access starting Jan. 2026, sales force expansion, and termination of the Kowa promotion agreement (Jan. 2026).