TORONTO, ON, October 27, 2026 — Arcutis Canada, Inc., a commercial-stage company focused on delivering meaningful innovations in immuno-dermatology, today announced that Health Canada has accepted for review the Supplement to a New Drug Submission (SNDS) for roflumilast cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis (AD) to include infants aged 3 to 24 months.

Atopic dermatitis is a chronic inflammatory skin disease that often begins early in life. While AD can affect people of all ages, it often starts before age five and commonly first appears in infancy, a time when the skin barrier and immune system are still developing. Characterized by persistent itch, AD can disrupt sleep and daily life, with impacts extending beyond the child to parents and caregivers.

If approved by Health Canada, roflumilast cream 0.05% would be the first once-daily, steroid-free, advanced targeted topical treatment in Canada for mild to moderate AD in infants as young as 3 months. Roflumilast selectively inhibits phosphodiesterase-4 (PDE4), an established therapeutic target in dermatology involved in inflammatory processes.

The SNDS is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study which evaluated the safety, tolerability and exploratory efficacy of once-daily roflumilast cream 0.05%, and a Phase 1 open-label pharmacokinetic study that evaluated pharmacokinetics and safety in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The INTEGUMENT-INFANT study enrolled 101 infants and assessed safety, tolerability, and exploratory efficacy over 4 weeks, while the Phase 1 study enrolled 19 infants. Results from the studies were consistent with those from prior atopic dermatitis studies in children 2 to 5 years of age treated with roflumilast cream 0.05%. Roflumilast cream 0.05% was generally well tolerated with no new safety signals identified.

About Topical Roflumilast
Arcutis is developing and commercializing topical cream and foam formulations of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.

Roflumilast cream 0.3% (^PrZORYVE) is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast foam 0.3% (ZORYVE) is approved by Health Canada for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, and for the topical treatment of seborrheic dermatitis in patients 9 years of age and older. Roflumilast cream 0.15% (ZORYVE) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. Roflumilast cream 0.05% (ZORYVE) is approved by Health Canada for the topical treatment of mild to moderate atopic dermatitis in patients 2 to 5 years of age.

Both roflumilast cream and foam formulations are non-greasy, moisturizing, are designed to absorb quickly and spread evenly, have a physiological skin pH, and exclude common sensitizing excipients and irritants, including propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, and fragrances.

For more information about roflumilast cream 0.3%, roflumilast cream 0.15%, roflumilast cream 0.05%, and roflumilast foam 0.3%, including prescribing and safety information, please consult the ZORYVE Canadian product monograph here.

About Arcutis

Arcutis Canada, Inc. is a subsidiary of Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise enables us to efficiently develop, scale and deliver our differentiated therapies while advancing a growing pipeline across a range of inflammatory dermatological conditions. For more information, visit www.arcutis.ca.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on The Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for approval and availability of roflumilast cream 0.05% in Canada for the treatment of mild to moderate atopic dermatitis in infants aged 3 months to 24 months, and the potential for roflumilast cream to advance the standard of care in atopic dermatitis and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:

Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations

ir@arcutis.com