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Arcutis lifts 2026 Zoryve sales guidance after Q3 revenue reaches $143.9M

🇺🇸 Arcutis Biotherapeutics, Inc. (ARQT) · Wed 04 Nov 2026

Arcutis raised its full-year sales outlook to $535–545 million, and the FDA has set a February 2027 action date for Zoryve cream in infants with atopic dermatitis.

Arcutis Biotherapeutics reported third-quarter 2026 results on 4 November, with net product sales of $143.9 million for Zoryve (roflumilast) and net income of $8.8 million. The company's headline for the period put sales growth at 45%.

On the back of the quarter, Arcutis raised its 2026 sales guidance to a range of $535 million to $545 million.

On the regulatory side, the US Food and Drug Administration has set a target action date of 23 February 2027 for a supplemental application. The filing seeks to extend Zoryve cream 0.05% to infants aged 3 to 24 months with mild to moderate atopic dermatitis.

Arcutis also expects a readout from a Phase 2 study of Zoryve in vitiligo by the end of the year. The summary available does not give further detail on the trial design or endpoints.

As general context, a target action date under the Prescription Drug User Fee Act is the date by which the FDA aims to complete its review of an application. It is not a guarantee of approval.

What it means for your team

  • Regulatory teams tracking paediatric dermatology should note the 23 February 2027 FDA target date for the infant atopic dermatitis extension.
  • A label extension to 3–24 months would, if approved, widen the youngest eligible age group for Zoryve cream 0.05%; the outcome remains subject to FDA review.
  • Market-access teams may watch the raised $535–545 million guidance as a marker of Zoryve's commercial trajectory.
  • The vitiligo Phase 2 readout expected by year-end could inform future indication planning, but no data have been released yet.

Company's press release (SEC filing): Arcutis Biotherapeutics, Inc. ↗

Article written by VigiEye from the official source (Arcutis Biotherapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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