News Release Details

• Simone Biles opens up about her experience managing the symptoms of these conditions and encourages long-term control of skin health
• Biles’ treatment, ZORYVE^® (roflumilast), is the #1 prescribed branded topical therapy for three major inflammatory skin conditions combined — seborrheic dermatitis, eczema, and plaque psoriasis
  
  

WESTLAKE VILLAGE, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that World Champion gymnast Simone Biles has partnered with the company to launch its Skin to Believe In awareness campaign. The campaign encourages the approximately 36 million Americans living with inflammatory skin conditions, such as seborrheic dermatitis and atopic dermatitis (the most common form of eczema), to talk with their doctor about long-term, steroid-free, topical treatment options for their chronic skin diseases.

Through the Skin to Believe In awareness campaign, Simone shares her personal journey of working with a healthcare provider to better understand and manage her seborrheic dermatitis and eczema, including using ZORYVE^® (roflumilast) foam and cream. Like many others, she spent years trying a range of over-the-counter products in search of relief from her symptoms before finding a steroid-free option that worked for her and fit into her routine. Her story highlights the persistent and profound impact of these conditions for sufferers — including itching and flaking — and the importance of finding solutions for clearer skin.

“A couple of years ago I started noticing flakes and itching on my scalp — especially on the crown of my head. At first, I thought it was a lot of dandruff, then I worried it might be something contagious. I also had patches of dry, itchy skin that kept appearing on my arms, and I wondered if the two were related. I tried over-the-counter products like shampoos and creams, but those didn’t work for me,” said Simone Biles. “Dealing with flakes in my hair was frustrating and made me feel uncomfortable, so I spoke with my dermatologist who diagnosed me with seborrheic dermatitis on my face and scalp and eczema on my arms. She recommended ZORYVE foam for my seborrheic dermatitis and ZORYVE cream for my eczema. I like ZORYVE because it is not a steroid, pill, injection, or shampoo and it's easy to use, not greasy, and fits into my routine. Using ZORYVE reduced the flakes and itching on my scalp, which bothered me the most, and the eczema spots on my arms are also clearer, too.”

A Media Snippet accompanying this announcement is available by clicking on this link.

“For years, conditions like seborrheic dermatitis and eczema could require multiple treatments, complex application schedules, and cycles of on and off use due to the limitations of the treatments. Now, we have access to innovative prescription treatments like ZORYVE that target the underlying inflammation driving these conditions, allowing us to improve symptoms," said Dr. Angela J. Lamb, board-certified dermatologist. “ZORYVE is a once-daily, steroid-free PDE4 inhibitor available in both foam and cream formulations that are non-greasy and don’t contain harmful ingredients that can disrupt the skin barrier. Finding solutions that can be used anywhere on the skin and continuously for any duration are important for long-term management of these chronic skin conditions."

ZORYVE foam 0.3% is indicated for the treatment of seborrheic dermatitis in adults and children 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with 77% of the 458 individuals using ZORYVE foam achieving clear or almost clear skin after 8 weeks of treatment compared to 53% of the 225 people using inactive foam in combined clinical trials.

ZORYVE cream 0.15% is indicated for the treatment of atopic dermatitis (eczema) in adults and children 6 years of age and older. In combined clinical trials of over 1,300 people, ZORYVE rapidly improved eczema symptoms such as redness, itching, and rash with once-daily treatment — with nearly a third (31% of the 884 people) achieving clear or almost clear skin at 4 weeks with ZORYVE cream compared to 14% of the 453 people using inactive cream, and many patients experiencing reduction in itch within 24 hours of the first application.

"As one of the most recognized athletes in the world, Simone Biles understands the significant challenges of living with a visible skin condition," said Frank Watanabe, president and CEO of Arcutis. "By sharing her story, she is helping to empower others to take control of their skin health by speaking with their healthcare provider about advanced, targeted treatment options like ZORYVE. This awareness campaign reinforces Arcutis’ commitment to delivering innovative therapies for inflammatory skin conditions, including seborrheic dermatitis and eczema, with flexible solutions designed to meet patients’ needs from head to toe."

“I’ve learned that we can’t fix every problem on our own and it’s OK to seek help,” continued Biles. “I believe how you care for yourself reflects how you carry yourself, and by partnering with Arcutis on this awareness campaign I believe we can break the stigma associated with chronic skin conditions by helping people feel empowered to speak with a healthcare provider about their symptoms so that they can find a treatment that works for them.”

ZORYVE is backed by robust clinical evidence, including eight pivotal trials involving approximately 4,200 participants. These studies consistently demonstrate that ZORYVE cream and foam are well tolerated. The most common side effects with ZORYVE cream 0.15% for eczema (atopic dermatitis) are headache, nausea, application site pain, and diarrhea. The most common side effects with ZORYVE foam 0.3% for seborrheic dermatitis are common cold, nausea, and headache. The adverse event profiles of ZORYVE cream and ZORYVE foam in the long-term studies with up to a year of treatment were consistent with those seen in the clinical studies.

For more information on ZORYVE cream and foam, including full prescribing information, please visit ZORYVE.com.

About ZORYVE^® (roflumilast)
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined — atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a topical formulation 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.

Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards and recommendations. ZORYVE was awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and ZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal of Recognition — the first FDA-approved prescription brand to receive the honor. Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released in June 2025. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.”

About the Skin to Believe In Awareness Campaign
The Skin to Believe In awareness campaign encourages people living with inflammatory skin conditions, including seborrheic dermatitis and eczema, to believe that relief is possible. The campaign empowers people to take the meaningful step of having a conversation with a healthcare provider about treatment options that fit seamlessly into their daily routine.

INDICATIONS
ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older.

ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients ages 2 to 5 years of age.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is 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.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

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 of ZORYVE cream and foam to simplify disease management for care of atopic dermatitis and seborrheic dermatitis, or the potential of real-world use results of ZORYVE on individual patients. 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