Arcutis’ ZORYVE® (roflumilast) Cream Receives Strong Recommendation in American Academy of Dermatology First-Ever Pediatric Atopic Dermatitis Guidelines

Rhea-AI Summary

Arcutis (Nasdaq: ARQT) announced that ZORYVE® (roflumilast) cream received a strong recommendation with high certainty in the American Academy of Dermatology pediatric atopic dermatitis guidelines (Apr 22, 2026).

The guidelines recommend ZORYVE 0.05% for ages 2–5 and ZORYVE 0.15% for ages 6 and older, citing clinically meaningful improvements in disease severity and itch and low treatment discontinuation rates.

Positive

• AAD issues strong recommendation for ZORYVE in pediatric atopic dermatitis
• Specific pediatric dosing: 0.05% for ages 2–5 and 0.15% for ages ≥6
• Guideline cites high certainty of evidence from multiple randomized trials

Negative

• Common adverse reactions ≥1% include headache, diarrhea, vomiting and upper respiratory events

News Market Reaction – ARQT

+1.50%

+1.50% Session close to close

In the Apr 22 session, ARQT gained 1.50%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights a strong, high-certainty endorsement of ZORYVE in the American Academy ...

Analysis

This announcement highlights a strong, high-certainty endorsement of ZORYVE in the American Academy of Dermatology’s first pediatric atopic dermatitis guidelines, specifying 0.05% dosing for ages 2–5 and 0.15% for ages 6+. It reinforces ZORYVE’s efficacy, safety, and tolerability for long-term use. In context with recent positive pediatric data and ongoing ZORYVE presentations, investors may watch how guideline inclusion influences prescribing patterns, while also monitoring future regulatory filings and capital-raising flexibility under the existing S-3ASR shelf.

Key Figures

U.S. pediatric AD prevalence: 9.6 million children ZORYVE dose (younger children): 0.05% ZORYVE dose (older children): 0.15% +5 more

8 metrics

U.S. pediatric AD prevalence 9.6 million children Children affected by atopic dermatitis in the United States

ZORYVE dose (younger children) 0.05% Recommended ZORYVE cream strength for ages 2–5 years

ZORYVE dose (older children) 0.15% Recommended ZORYVE cream strength for ages 6 years and older

Pediatric age range (younger) 2–5 years Guideline recommendation age range for ZORYVE 0.05% in atopic dermatitis

Pediatric age cutoff 6 years and older Guideline recommendation age group for ZORYVE 0.15% in atopic dermatitis

Adverse event threshold ≥1% Incidence threshold used to describe common adverse reactions in trials

Guideline recommendations 27 recommendations Total evidence-based recommendations in pediatric atopic dermatitis guidelines

Pediatric upper age limit Under 18 years Age scope for the pediatric atopic dermatitis guidelines

Historical Context

5 past events · Latest: Apr 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 15	Earnings date notice	Neutral	-1.6%	Scheduled Q1 2026 earnings release and conference call announcement.
Mar 31	Conference participation	Neutral	+2.3%	Management presenting and hosting a fireside chat at healthcare conference.
Mar 18	Clinical data previews	Positive	-2.1%	New ZORYVE clinical and long-term caregiver-reported data at AAD meeting.
Mar 10	Pediatric efficacy data	Positive	-0.9%	Positive long-term Phase 3 safety and efficacy data for ZORYVE 0.05% in children.
Mar 05	Management promotion	Neutral	-0.6%	Promotion of chief legal officer to support commercialization and growth.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent ARQT news, including positive clinical and publication updates on ZORYVE, has often seen muted or negative next-day price reactions, even when content was favorable.

Recent Company History

Over the past two months, Arcutis has focused on advancing and publicizing its ZORYVE franchise. On Mar 10, long-term Phase 3 data in children 2–5 showed durable efficacy and favorable safety, yet the stock moved -0.93%. New clinical data presentations at the AAD meeting on Mar 18 saw a -2.11% reaction. A management promotion on Mar 5 and conference participation on Mar 31 had modest mixed impacts. Today’s strong AAD pediatric guideline recommendation fits this ongoing ZORYVE-focused narrative.

Key Terms

phosphodiesterase type 4 (pde4) inhibitor, atopic dermatitis, pruritus, randomized controlled trials, +3 more

7 terms

phosphodiesterase type 4 (pde4) inhibitor medical

"steroid-free topical phosphodiesterase type 4 (PDE4) inhibitor"

A phosphodiesterase type 4 (PDE4) inhibitor is a type of medication that blocks an enzyme responsible for turning off certain cell-to-cell signals, so those signals last longer and reduce inflammation or abnormal immune activity. Investors care because these drugs can target conditions such as respiratory, inflammatory, or neurological disorders; progress in trials, safety profile, and regulatory approval can significantly affect a company’s drug pipeline value and market potential.

atopic dermatitis medical

"Atopic dermatitis affects approximately 9.6 million children in the United States"

A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.

pruritus medical

"demonstrating significant improvements in clinical signs, pruritus (itch), and patient-reported outcomes"

Pruritus is the medical term for an unpleasant itch sensation that makes a person want to scratch, ranging from mild irritation to severe, persistent discomfort like an itch you can’t stop rubbing. For investors, it matters because it can be a key symptom or side effect in clinical trials, affect drug labeling and regulatory decisions, drive market demand for treatments, and signal safety or tolerability issues that influence a healthcare product’s commercial prospects.

randomized controlled trials medical

"based on multiple randomized controlled trials demonstrating significant improvements"

Randomized controlled trials are studies where participants are randomly assigned to receive either a new treatment or a comparison (such as a standard treatment or placebo), so outcomes can be fairly compared like flipping a coin to decide teams. For investors, they matter because they provide the most reliable evidence about whether a drug, device or intervention actually works and is safe, which influences regulatory approval, market demand and the financial outlook of companies developing them.

systemic therapies medical

"lower risk than systemic therapies"

Systemic therapies are treatments designed to travel through the bloodstream and affect the whole body rather than a single spot, like taking a pill or an IV drug that reaches many organs. Investors care because these therapies can address widespread or hard-to-reach disease, often involve larger patient populations, recurring use, and greater regulatory and safety scrutiny, all of which influence potential market size, pricing power, and long‑term revenue.

topical therapies medical

"topical therapies, including both prescription topical treatments and nonprescription moisturizers"

Topical therapies are medicines or treatments applied directly to the skin or other body surfaces—think creams, gels, lotions or patches—designed to work where they are put on rather than being swallowed or injected. For investors, they matter because their development, manufacturing and regulatory hurdles tend to differ from systemic drugs, affecting speed to market, cost, patent strength and how easily products can reach consumers—similar to comparing a surface repair job to rebuilding an entire structure.

topical phosphodiesterase-4 inhibitors medical

"Among topical phosphodiesterase-4 inhibitors, ZORYVE cream received a strong recommendation"

A class of medicines applied directly to the skin that block an enzyme called phosphodiesterase-4 to reduce inflammation and itching; think of them as turning down an internal “alarm” that triggers redness and irritation. They matter to investors because regulatory approvals, safety, and market uptake in common skin conditions such as eczema can drive sales, affect clinical-development risk, and influence a company’s growth prospects in dermatology.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• Strong recommendation with high certainty of clinical evidence underscores proven efficacy, safety, and tolerability of ZORYVE cream as a steroid-free topical phosphodiesterase type 4 (PDE4) inhibitor
• Atopic dermatitis affects approximately 9.6 million children in the United States

WESTLAKE VILLAGE, Calif., April 22, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream has received a strong recommendation, with high certainty of clinical evidence, in the American Academy of Dermatology (AAD) clinical practice guidelines for the management of pediatric atopic dermatitis.

The AAD’s evidence-based guidelines recommend the use of ZORYVE cream 0.05% for children aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis, recognizing its efficacy, safety, and tolerability. The recommendation reinforces ZORYVE’s ability to deliver clinically meaningful improvements in disease severity and itch with very low rates of treatment discontinuation, offering an effective topical suitable for long-term use anywhere on the body in both children and adolescents. In clinical trials, the most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients 2 to 5 years of age with atopic dermatitis were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache. The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients 6 years of age or older with atopic dermatitis were headache, nausea, application site pain, diarrhea, and vomiting.

“The AAD’s strong recommendation for ZORYVE cream, building on its previous strong recommendation in adults, reflects the high certainty of evidence supporting its efficacy, low rates of treatment discontinuation, and favorable tolerability in pediatric patients. These evidence-based recommendations help clinicians make informed treatment decisions for children, adolescents, and their caregivers managing this chronic condition and reinforce the value of ZORYVE as a topical PDE4 inhibitor,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Since atopic dermatitis is a lifelong condition that often begins in childhood, when the immune system and skin barrier are still developing, it is critical to have therapies that balance efficacy with long-term safety and tolerability. ZORYVE does not include ingredients or irritants known to compromise the skin barrier, which is especially important in these age groups.”

The pediatric guidelines were developed by a multidisciplinary workgroup using a systematic evidence review and the GRADE framework to assess certainty of evidence and strength of recommendations. The update includes 27 evidence-based recommendations spanning topical therapies, phototherapy, and systemic treatments for children and adolescents under 18 years of age. Among topical phosphodiesterase-4 inhibitors, ZORYVE cream received a strong recommendation supported by high-certainty of evidence, based on multiple randomized controlled trials demonstrating significant improvements in clinical signs, pruritus (itch), and patient-reported outcomes with a favorable tolerability profile. Overall, the guidelines emphasize that topical therapies, including both prescription topical treatments and nonprescription moisturizers, are the “cornerstone of atopic dermatitis management as these therapies are generally effective and lower risk than systemic therapies.”

For more information on ZORYVE, including full prescribing information, please visit www.zoryve.com.

About Atopic Dermatitis
Atopic dermatitis is the most common type of eczema and occurs with the highest prevalence in children, affecting approximately 9.6 million children and 16.5 million adults in the United States. Atopic dermatitis is a chronic, relapsing, and genetically predisposed inflammatory skin disease that can significantly impact quality of life for both patients and caregivers. The disease presents with intensely itchy, inflamed skin and may appear differently across the pediatric age spectrum, from infancy through adolescence.

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.”

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

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.

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

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 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%).

Please see full Prescribing Information for ZORYVE cream.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage 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.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 to advance the standard of care in atopic dermatitis, including pediatric 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

FAQ

What did the AAD recommend for ZORYVE (ARQT) in the April 22, 2026 pediatric guidelines?

The AAD gave a strong recommendation with high-certainty evidence for ZORYVE in pediatric atopic dermatitis. According to the company, the guidance endorses 0.05% for ages 2–5 and 0.15% for ages 6 and older with favorable tolerability.

What doses of ZORYVE does the AAD guideline recommend for children and adolescents (ARQT)?

The guideline recommends ZORYVE 0.05% for ages 2–5 and 0.15% for ages 6+. According to the company, recommendations target mild to moderate atopic dermatitis based on randomized trial evidence.

How does the guideline describe ZORYVE’s clinical benefits for pediatric patients (ARQT)?

ZORYVE is described as delivering clinically meaningful improvements in disease severity and itch with low discontinuation rates. According to the company, multiple randomized trials support these patient‑reported and clinical outcomes.

What safety or adverse reactions were reported for pediatric ZORYVE use (ARQT)?

The most common adverse reactions ≥1% include headache, nausea, diarrhea, vomiting, and upper respiratory infections. According to the company, these events were observed in pediatric clinical trials for the respective concentrations.

Who developed the pediatric atopic dermatitis guidelines that recommended ZORYVE (ARQT)?

A multidisciplinary workgroup developed the pediatric guidelines using a systematic evidence review and the GRADE framework. According to the company, the update includes 27 evidence‑based recommendations for patients under 18.

Does the guideline recommend ZORYVE for long‑term use in pediatric patients (ARQT)?

Yes. The guideline recognizes ZORYVE as an effective topical suitable for long‑term use anywhere on the body in children and adolescents. According to the company, tolerability and low discontinuation support this role.