TORONTO, ON, February 9, 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 0.3% for the topical treatment of plaque psoriasis to include patients as young as 2 years old.

Roflumilast cream 0.3% (ZORYVE^®) is currently approved in Canada for the topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older. If approved, this expanded indication would provide Canadian children as young as 2 years old with a steroid-free, once-daily topical option designed for long-term disease control and formulated for use across all body areas, including sensitive areas such as the face and intertriginous skin.

Psoriasis is a chronic, immune-mediated inflammatory disease of the skin that affects approximately 3% of the Canadian population—about one million Canadians—and roughly 1% of Canadian children.^1,2 Approximately one third of individuals with psoriasis experience disease onset before age 20, and an estimated 10% develop psoriasis before age 10, underscoring the need for effective and well-tolerated treatment options suitable for young patients.³ In children, plaque psoriasis most commonly appears on the face, scalp, and intertriginous regions⁴, which can be particularly challenging to manage. The disease can cause persistent itching, pain, and psychosocial distress, impacting both quality of life and family wellbeing.⁵ Effective and well-tolerated treatment options are critical to support long-term disease control and improve quality of life for children and their families.

The SNDS to Health Canada is supported by data from three studies evaluating the efficacy, pharmacokinetics, and long-term safety of once-daily roflumilast cream 0.3% in pediatric patients with plaque psoriasis:

If approved, ZORYVE cream 0.3% would become the first and only topical phosphodiesterase-4 (PDE4) inhibitor in Canada indicated for plaque psoriasis in patients as young as 2 years old, offering younger children and their caregivers a new therapeutic alternative.

About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.

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.

Both roflumilast cream and foam formulations feature HydroARQ Technology™. The formulations are non-greasy, moisturizing, are designed to absorb quickly and spread evenly and 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%, 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 medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for 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 approval of roflumilast cream 0.3% in Canada for the treatment of plaque psoriasis to include patients 2 years of age and older, the potential for roflumilast cream to enhance available options for plaque psoriasis, and the potential to use roflumilast cream over a long period of time, or chronically. 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, 2025, 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

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