Arcutis Announces Positive Topline Results for INTEGUMENT-INFANT Phase 2 Trial of ZORYVE® (roflumilast) Cream 0.05% in Infants with Mild to Moderate Atopic Dermatitis

Rhea-AI Summary

Arcutis (Nasdaq: ARQT) reported positive topline results from the INTEGUMENT-INFANT Phase 2 trial of ZORYVE cream 0.05% (roflumilast) in infants 3 months to 24 months with mild–moderate atopic dermatitis. At Week 4, . The cream was well tolerated with no new safety signals through four weeks. The company plans an sNDA submission in Q2 2026 for this age group.

Positive

• 58% EASI-75 at Week 4 in infants
• Safety profile consistent with prior ZORYVE trials; no new safety signals through 4 weeks
• sNDA planned for Q2 2026 targeting infant indication

Negative

• Most frequent AEs ≥3% included diarrhea, nasopharyngitis, URTI, vomiting
• Data are limited to a 4-week treatment period

Key Figures

EASI-75 response: 58% Treatment duration: 4 weeks US pediatric AD patients: 9.6 million +5 more

8 metrics

EASI-75 response 58% Participants achieving EASI-75 at Week 4 with ZORYVE 0.05% in INTEGUMENT-INFANT

Treatment duration 4 weeks Evaluation period for efficacy and safety in INTEGUMENT-INFANT Phase 2

US pediatric AD patients 9.6 million Children in the United States impacted by atopic dermatitis

Early-onset AD 60% Children with atopic dermatitis developing symptoms within first year

Infant age range 3 to <24 months Age eligibility for INTEGUMENT-INFANT atopic dermatitis study

Common AE threshold ≥3% Frequency cutoff for most common adverse events (n=101) in trial

Trial participants 101 Number of infants in safety analysis for adverse event reporting

Discontinuations 1 participant Number of participants who discontinued due to an adverse event

Market Reality Check

Price: $25.57 Vol: Volume 906,185 is below t...

low vol

$25.57 Last Close

Volume Volume 906,185 is below the 20-day average of 1,496,715 (relative volume 0.61x) ahead of this news. low

Technical Shares at $25.37 were trading above the 200-day MA of $19.58 and about 20% below the 52-week high, after rising well above the $11.13 52-week low.

Peers on Argus

Before this positive trial update, ARQT was down 1.4% while key biotech peers li...

Before this positive trial update, ARQT was down 1.4% while key biotech peers like APGE, TARS, AGIO, IRON, and TVTX also showed negative returns (from about -0.07% to -5.09%). Scanner data did not flag a coordinated sector momentum move, suggesting the setup was more stock-specific than a broad rotation.

Previous Clinical trial Reports

5 past events · Latest: Nov 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 17	sNDA accepted	Positive	+4.7%	FDA accepted sNDA for ZORYVE 0.3% in plaque psoriasis ages 2–5.
Nov 13	Trial enrollment	Positive	-2.5%	Completed enrollment in INTEGUMENT-INFANT Phase 2 atopic dermatitis study.
Sep 03	sNDA submitted	Positive	+4.0%	Submitted sNDA to expand ZORYVE 0.3% psoriasis indication to ages 2–5.
Mar 07	Phase 3 data	Positive	+1.5%	Presented positive Phase 3 data in scalp/body psoriasis and atopic dermatitis.
Sep 19	Trial publication	Positive	-2.5%	Published pivotal Phase 3 INTEGUMENT-1/-2 AD results for ZORYVE 0.15%.

Pattern Detected

Clinical and regulatory milestones for ZORYVE have generally been received positively, but reactions were mixed, with both gains and declines following favorable updates.

Recent Company History

Over the past year, Arcutis has repeatedly advanced ZORYVE in new indications and age groups. Prior clinical news included sNDA submissions and FDA acceptance for ZORYVE cream 0.3% in children 2–5, Phase 3 data in atopic dermatitis and psoriasis, and completion of enrollment in the INTEGUMENT-INFANT study. Price reactions to these clinical milestones ranged from about -2.52% to +4.68%, indicating that even positive data have sometimes produced muted or negative trading responses, which is relevant context for today’s favorable infant Phase 2 topline results.

Historical Comparison

clinical trial

+3.0 %

Average Historical Move

Historical Analysis

In the last five clinical-trial-related announcements, ARQT moved an average of about ±3.05%. Today’s infant Phase 2 topline sits within an established pattern where positive ZORYVE data have produced modest single-digit percentage stock moves.

Typical Pattern

Clinical news shows a steady ZORYVE expansion: Phase 3 AD data in older patients, then sNDA submission and FDA acceptance for psoriasis in ages 2–5, followed by INTEGUMENT-INFANT enrollment completion and now positive topline results in infants with atopic dermatitis.

Market Pulse Summary

This announcement delivers positive Phase 2 topline data for ZORYVE 0.05% in infants with atopic der...

Analysis

This announcement delivers positive Phase 2 topline data for ZORYVE 0.05% in infants with atopic dermatitis, with 58% of participants achieving EASI-75 at Week 4 and a safety profile consistent with prior trials. It extends a multi-year pattern of ZORYVE development across age groups and indications. Investors may track the planned sNDA submission in Q2 2026, subsequent regulatory interactions, and how this infant program complements already approved pediatric uses.

Key Terms

atopic dermatitis, supplemental new drug application (snda), adverse events

3 terms

atopic dermatitis medical

"infants aged 3 months to less than 24 months with atopic dermatitis. ZORYVE cream..."

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.

supplemental new drug application (snda) regulatory

"The Company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05%"

A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.

adverse events medical

"Overall, the incidence of adverse events was low, with all being mild to moderate"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

AI-generated analysis. Not financial advice.

• 58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4
• Investigational ZORYVE cream 0.05% was well tolerated and demonstrated a safety profile consistent with previous studies, with no new safety signals identified through 4 weeks of treatment
• Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year
• The Company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for this age group in Q2 2026

WESTLAKE VILLAGE, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from the INTEGUMENT-INFANT Phase 2 study evaluating the safety, tolerability, and efficacy of ZORYVE® (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis. ZORYVE cream, a highly selective and potent topical phosphodiesterase 4 (PDE4) inhibitor, was well tolerated with a safety profile consistent with previous ZORYVE clinical trials. Overall, the incidence of adverse events was low, with all being mild to moderate in severity. ZORYVE cream improved the severity of disease and reduced the area of skin affected by atopic dermatitis, with 58% of participants achieving EASI-75 at Week 4.

“Atopic dermatitis is the most common type of eczema and often starts in infancy. For our youngest patients, it’s critical to have therapies that are both safe and effective and that can be used on all body areas, including the face and diaper region,” said Mercedes E Gonzalez, MD, pediatric dermatologist and co-founder of Dermatology360 and INTEGUMENT-INFANT investigator. “These data underscore the potential of investigational ZORYVE cream 0.05% to provide meaningful improvements in the signs and symptoms of atopic dermatitis, while reinforcing its well-established and consistent safety profile.”

The Phase 2 study results reinforce the consistency of the safety and tolerability profile of ZORYVE cream 0.05% already seen in the four-week pivotal INTEGUMENT-PED clinical trial in children ages 2 to 5 years. The most frequently reported adverse events (≥3%; n=101) included: diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one trial participant discontinued the study due to an adverse event, and there were no serious adverse events.

“Reaching this clinical development milestone for ZORYVE through the INTEGUMENT‑INFANT study underscores our commitment toward providing safe, effective non-steroidal treatment options for even the youngest patients with atopic dermatitis who have substantial disease burden and very limited treatment options today. Based on my experience as a pediatric dermatologist, demonstrating efficacy and tolerability in infants — using a formulation specifically developed with young children suffering from atopic dermatitis in mind—not only advances our development program but gives hope to our patients and their families who are suffering with the burdensome symptoms of atopic dermatitis,” said David Berk, MD, FAAD, vice president of R&D strategy and clinical development at Arcutis. “We want to thank the investigators, caregivers, and children who participated in this study for their partnership and commitment, which make advances like this possible.”

About the INTEGUMENT-INFANT Study
The INTEGUMENT-INFANT Phase 2, open-label, multicenter study evaluated the safety and tolerability of ZORYVE cream 0.05% applied once daily over a four-week period in 101 infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The study builds upon the earlier Maximal Usage (MUSE) pharmacokinetics trial ARQ-151-105, which also evaluated ZORYVE cream 0.05% in this age group.

About Atopic Dermatitis
Atopic dermatitis is the most common type of eczema, 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 has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults. Younger children typically have more widespread atopic dermatitis, including on the face, neck, and areas around the knees and elbows.

Atopic dermatitis is often initially diagnosed during childhood, with approximately 60% of children developing symptoms within their first year. Pediatric atopic dermatitis can negatively impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers.

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 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 recently awarded by Allure with the "2025 Best of Beauty Breakthrough Award," making it the first U.S. Food and Drug Administration (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. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Best Eczema Product.” Additionally, the American Academy of Dermatology 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.

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 allow 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.

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.

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

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 timing of the submission of the sNDA for ZORYVE cream 0.05%, statements regarding the potential that clinical trial results will translate to real-world use of ZORYVE cream, and the potential for ZORYVE cream to advance the standard of care in atopic dermatitis. 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

FAQ

What were the INTEGUMENT-INFANT Phase 2 results for ARQT (ZORYVE) in infants?

The trial met its topline endpoints with 58% of infants achieving EASI-75 at Week 4. According to the company, the cream was well tolerated and showed a safety profile consistent with prior ZORYVE studies through four weeks.

What safety findings did Arcutis report for ZORYVE cream 0.05% (ARQT) in the infant study?

ZORYVE cream 0.05% was generally well tolerated with low incidence of adverse events. According to the company, most adverse events were mild to moderate and no serious adverse events or new safety signals were observed through four weeks.

Will Arcutis (ARQT) seek regulatory approval for ZORYVE in infants and when?

Arcutis plans to submit a supplemental NDA for the infant indication in Q2 2026. According to the company, topline Phase 2 data support an sNDA filing targeting regulatory review for this age group.

How quickly did infants show improvement with ZORYVE cream 0.05% in the ARQT study?

Clinical improvement was observed by Week 4, with 58% achieving EASI-75. According to the company, the four-week readout demonstrated both reduced affected skin area and improved disease severity in infants.

What adverse events were most commonly reported in the ARQT infant trial of ZORYVE cream?

The most frequently reported events (≥3%) were diarrhea, nasopharyngitis, upper respiratory infection, and vomiting. According to the company, only one participant discontinued due to an adverse event and there were no serious adverse events.