Arcutis to Present New Clinical Data in a Late-Breaking Podium Presentation and Scientific Posters at the 2026 American Academy of Dermatology Annual Meeting

Rhea-AI Summary

Arcutis (Nasdaq: ARQT) will present new clinical and long-term caregiver-reported data for its marketed ZORYVE (roflumilast) portfolio at the 2026 American Academy of Dermatology Annual Meeting, March 27–31 in Denver. Key presentations include a late-breaking podium on the INTEGUMENT-INFANT Phase 2 trial (infants 3–<24 months) and Phase 3 subgroup and PASI results from STRATUM, DERMIS-1/2, ARRECTOR, and INTEGUMENT-OLE (ages 2–5).

The program includes a late-breaking podium (Mar 28), a 5-minute poster (Mar 27), and multiple e-posters available beginning Mar 27.

Positive

• Late-breaking podium inclusion for INTEGUMENT-INFANT (Mar 28)
• New infant data for ZORYVE 0.05% in ages 3–<24 months
• Long-term caregiver outcomes from INTEGUMENT-OLE in ages 2–5
• Multiple Phase 3 readouts including STRATUM, DERMIS-1/2, ARRECTOR

Negative

• None.

Key Figures

EASI-75 responders: 58% PDUFA date: June 29, 2026 INTEGUMENT 1-2 sample size: 1,337 patients +5 more

8 metrics

EASI-75 responders 58% Week 4 INTEGUMENT-INFANT Phase 2 trial topline results

PDUFA date June 29, 2026 FDA acceptance of sNDA for ZORYVE cream 0.3% in plaque psoriasis ages 2–5

INTEGUMENT 1-2 sample size 1,337 patients Phase 3 AD trials presented at 2025 AAD meeting

US AD prevalence ~26 million Adults and children affected by atopic dermatitis in the US

US psoriasis prevalence ~9 million Adults and children with psoriasis in the US

Q4 2025 net product revenue $127.5M ZORYVE net product revenue, Q4 2025

FY 2025 net product revenue $372.1M ZORYVE full-year 2025 net product revenue

2026 sales guidance $480–$495M Company 2026 net product sales guidance for ZORYVE

Market Reality Check

Price: $22.24 Vol: Volume 1,384,922 vs 20-da...

normal vol

$22.24 Last Close

Volume Volume 1,384,922 vs 20-day average 1,455,521 (relative volume 0.95) ahead of the AAD data presentations. normal

Technical Shares at $22.72 are trading above the 200-day MA of $21.36 while sitting 28.49% below the 52-week high and 91.57% above the 52-week low.

Peers on Argus

ARQT was down 0.18% while close peers were mixed: APGE -0.94%, IRON -0.46%, TVTX...

ARQT was down 0.18% while close peers were mixed: APGE -0.94%, IRON -0.46%, TVTX -1.03% versus TARS +1.76% and AGIO +0.84%, indicating stock-specific trading rather than a broad biotech move.

Previous Clinical trial Reports

5 past events · Latest: Feb 02 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 02	Phase 2 topline data	Positive	+0.8%	Reported positive INTEGUMENT-INFANT topline results with 58% achieving EASI-75.
Nov 17	FDA sNDA acceptance	Positive	+4.7%	FDA accepted sNDA for ZORYVE 0.3% in plaque psoriasis ages 2–5 with set PDUFA date.
Nov 13	Trial enrollment complete	Positive	-2.5%	Completed enrollment for INTEGUMENT-INFANT Phase 2 atopic dermatitis study in infants.
Sep 03	sNDA submission	Positive	+4.0%	Submitted sNDA to expand ZORYVE 0.3% psoriasis indication to children ages 2–5.
Mar 07	AAD Phase 3 data	Positive	+1.5%	Presented Phase 3 ZORYVE data for psoriasis and atopic dermatitis at 2025 AAD meeting.

Pattern Detected

Clinical and regulatory dermatology updates have usually led to modest positive moves, with one notable negative reaction after INTEGUMENT-INFANT enrollment completion.

Recent Company History

Recent history shows a steady stream of ZORYVE clinical and regulatory milestones. Positive INTEGUMENT-INFANT Phase 2 topline data on Feb 2, 2026 and earlier enrollment completion in November 2025 advanced the infant atopic dermatitis program. Separate sNDAs and FDA acceptance for ZORYVE 0.3% in plaque psoriasis for ages 2–5 expanded the pediatric focus. Prior AAD meeting data in March 2025 highlighted Phase 3 scalp, body psoriasis, and atopic dermatitis results, setting a precedent for today’s new AAD presentations.

Historical Comparison

+1.7% avg move · In the last five clinical-trial announcements, ARQT moved an average of 1.7%, suggesting that AAD da...

clinical trial

+1.7%

Average Historical Move clinical trial

In the last five clinical-trial announcements, ARQT moved an average of 1.7%, suggesting that AAD data updates have historically produced modest but directionally positive reactions.

Clinical news shows a progression from INTEGUMENT-INFANT enrollment, to positive Phase 2 topline data, to broader AAD presentations, alongside pediatric psoriasis sNDAs and FDA review milestones for ZORYVE.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-25

Arcutis has an effective S-3ASR shelf filed on 2026-02-25, covering multiple security types and allowing both primary issuances and resales by selling securityholders; the company will not receive proceeds from selling securityholders’ resales according to the prospectus.

Market Pulse Summary

This announcement expands the evidence base for ZORYVE across atopic dermatitis, seborrheic dermatit...

Analysis

This announcement expands the evidence base for ZORYVE across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, including infant and toddler populations. Prior INTEGUMENT-INFANT and pediatric psoriasis milestones, plus strong 2025 revenue of $372.1M and 2026 sales guidance of $480–$495M, frame these AAD presentations within a broader growth story. Investors may watch for detailed efficacy, safety, and caregiver-reported outcomes once full data are shared.

Key Terms

psoriasis area and severity index (pasi)

1 terms

psoriasis area and severity index (pasi) medical

"and Psoriasis Area and Severity Index (PASI) outcomes from the Phase 3 DERMIS-1/2"

A psoriasis area and severity index (PASI) is a clinical scoring system that measures how much of the body is affected by psoriasis and how severe the lesions are, combining area and intensity into a single number. Think of it like a composite grade that summarizes both coverage and severity. Investors watch PASI results because changes in the score are common trial endpoints and regulatory benchmarks that drive drug approval chances, market value, and commercial potential.

AI-generated analysis. Not financial advice.

WESTLAKE VILLAGE, Calif., and DENVER, March 18, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will present new data from its clinical development program and marketed ZORYVE^® (roflumilast) portfolio during the 2026 American Academy of Dermatology (AAD) Annual Meeting taking place March 27-31 in Denver.

In an AAD late-breaking podium presentation, the Company will share new efficacy, safety, and tolerability results from its INTEGUMENT-INFANT Phase 2 trial evaluating investigational once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis, building on recently announced topline data. In addition, a five-minute poster presentation will highlight long-term caregiver-reported outcomes from its INTEGUMENT-OLE Phase 3 trial of ZORYVE cream 0.05% in children aged 2 to 5 years with mild to moderate atopic dermatitis. Additional results will be presented in two e-posters from a STRATUM Phase 3 trial subgroup analysis in individuals with seborrheic dermatitis with face and scalp involvement, and Psoriasis Area and Severity Index (PASI) outcomes from the Phase 3 DERMIS-1/2 and ARRECTOR trials in individuals with plaque psoriasis.

“This year’s AAD presentations reflect the continued momentum of our clinical development program and the expanding body of evidence supporting the value of ZORYVE across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “We are particularly excited to share new results from the INTEGUMENT‑INFANT trial evaluating investigational ZORYVE cream 0.05% in infants with mild to moderate atopic dermatitis, with its inclusion as a late‑breaking session underscoring the need for additional therapeutic options for this underserved pediatric age group.”

Details of the presentations are as follows:

• Podium: INTEGUMENT-INFANT: Once-Daily Roflumilast Cream 0.05% in Infants Aged 3–<24 Months With Atopic Dermatitis
  Abstract: #79891
  Presenter: Lawrence F. Eichenfield, MD
  Late-Breaking Session 1
  Date: Saturday, March 28
  Time: 10:12–10:24 a.m. MDT
  Location: Bellco Theatre 3

• 5-minute Poster Presentation: Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.05% in Caregiver-Reported Outcomes: Long-Term Results for Patients Aged 2–5 Years With Mild to Moderate Atopic Dermatitis in the INTEGUMENT-OLE Trial
  Presenter: Lawrence F. Eichenfield, MD
  Date: Friday, March 27
  Time: 4:25–4:30 p.m. MDT
  Location: Lobby C, Poster Center 1

Poster Presentations
The following posters will be available electronically at the conference beginning Friday, March 27:

• E-Poster: Roflumilast Foam 0.3% in Patients With Seborrheic Dermatitis: Subgroup Analysis of Patients With Involvement of the Face and/or Scalp in the STRATUM Trial
  Lead Author: Laura Ferris, MD

• E-Poster: Roflumilast Cream 0.3% and Foam 0.3% in Psoriasis Area and Severity Index (PASI) Across Body Regions and Clinical Signs for Patients With Plaque Psoriasis
  Lead Author: Melinda Gooderham, MD

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 cream 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 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.

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.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

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 0.05% 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%).

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 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.

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 investigational ZORYVE cream 0.05% to achieve the desired clinical trial results and to advance the standard of care in atopic dermatitis in infants aged 3–<24 months, and long-term use in children aged 2-5 years old, and the use of ZORYVE in seberrheic dermatitis and plaque psoriasis. 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 data will ARQT present at AAD 2026 regarding infants and ZORYVE?

Arcutis will present late-breaking Phase 2 efficacy, safety, and tolerability results for infants. According to the company, the INTEGUMENT-INFANT trial evaluates once-daily ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis.

When and where is Arcutis presenting the INTEGUMENT-INFANT late-breaking podium (ARQT)?

The INTEGUMENT-INFANT late-breaking podium is scheduled for March 28 at Bellco Theatre 3. According to the company, the session runs 10:12–10:24 a.m. MDT and will feature a presentation by Lawrence F. Eichenfield, MD.

What will the INTEGUMENT-OLE poster for ARQT cover at AAD 2026?

The INTEGUMENT-OLE poster highlights long-term caregiver-reported outcomes for children aged 2–5 years. According to the company, it reports once-daily and proactive twice-weekly ZORYVE cream 0.05% results and is a five-minute poster on March 27 at 4:25 p.m. MDT.

Which Phase 3 subgroup and PASI analyses will ARQT present at the AAD meeting?

Arcutis will present STRATUM subgroup analysis and PASI outcomes from DERMIS-1/2 and ARRECTOR trials. According to the company, e-posters cover seborrheic dermatitis face/scalp subgroups and PASI across body regions beginning March 27.

How does ARQT describe the significance of the AAD 2026 presentations for ZORYVE?

Arcutis says the presentations expand clinical evidence supporting ZORYVE across multiple conditions. According to the company, results span atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, reinforcing the program's momentum and pediatric data emphasis.