Welcome to our dedicated page for Arcutis Biotherapeutics news (Ticker: ARQT), a resource for investors and traders seeking the latest updates and insights on Arcutis Biotherapeutics stock.
News for Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) centers on its role as a commercial-stage medical dermatology and biopharmaceutical company focused on immune-mediated skin diseases. Company announcements frequently highlight developments in its ZORYVE (roflumilast) topical franchise for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis, along with updates on its broader immuno-dermatology pipeline.
Investors and clinicians following ARQT news can expect detailed coverage of regulatory milestones, such as U.S. Food and Drug Administration (FDA) approvals and supplemental new drug application (sNDA) acceptances for new age groups and indications. Releases describe label expansions for ZORYVE cream and foam, including approvals for pediatric atopic dermatitis and seborrheic dermatitis, and FDA review timelines for potential new pediatric plaque psoriasis indications.
Arcutis also reports on clinical trial progress and data presentations. Recent news includes completion of enrollment in pediatric studies like INTEGUMENT-INFANT, publication of long-term safety and efficacy data for ZORYVE foam 0.3% in seborrheic dermatitis, and new Phase 3 analyses showing improvements in itch, sleep disruption, and long-term disease control with ZORYVE cream 0.15% and 0.05% in atopic dermatitis.
Financial and corporate updates form another key news category. The company issues quarterly earnings releases detailing net product revenue for ZORYVE, outlines strategies for sustainable growth, and provides guidance on future net product sales. Additional items include inducement equity grants, participation in investor conferences, and board-level changes disclosed via press releases and Form 8-K filings.
News flow also covers pipeline and strategic priorities, such as Phase 2 proof-of-concept trials of ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa, and early clinical development plans for ARQ-234, a CD200 receptor checkpoint agonist being developed as a potential biologic for atopic dermatitis. Together, these updates give readers insight into Arcutis’ commercial performance, regulatory trajectory, and ongoing research in immuno-dermatology.
Arcutis (Nasdaq: ARQT) submitted an sNDA to the FDA to expand ZORYVE cream 0.05% (roflumilast) for treatment of mild-to-moderate atopic dermatitis in infants aged ≥3 months to 24 months.The filing is supported by a Phase 1 PK trial (n=19) and the Phase 2 INTEGUMENT-INFANT study (n=101) reporting tolerability and multiple efficacy endpoints, including 34.4% vIGA-AD success at Week 4 and 58.3% EASI-75 at Week 4.
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.
Arcutis (Nasdaq: ARQT) will report first quarter 2026 financial results and provide a business update on Wednesday, May 6, 2026 after U.S. markets close. The company will host a conference call and webcast the same day at 4:30 PM ET.
A live webcast and presentation materials will be available in the Events section of the company website, with a replay posted on Arcutis investor site after the call.
Arcutis (Nasdaq: ARQT) said its management team will present at the 25th Annual Needham Virtual Healthcare Conference, April 13-16, 2026. The company will host a Fireside Chat on April 14, 2026 at 11:00 AM ET.
According to the company, the live webcast is available in the Events section of its website, and a replay will be accessible for 180 days after the conference.
Arcutis (Nasdaq: ARQT) presented Phase 2 INTEGUMENT-INFANT data showing investigational ZORYVE cream 0.05% reduced signs and symptoms of mild-to-moderate atopic dermatitis in infants 3 months to <24 months over four weeks and was well tolerated.
Key outcomes include vIGA-AD, EASI-75, scalp results, rapid caregiver-reported itch relief, and safety findings consistent with prior pediatric studies.
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.
Arcutis (Nasdaq: ARQT) reported long-term Phase 3 open-label extension data for ZORYVE cream 0.05% in children ages 2–5 with mild-to-moderate atopic dermatitis, showing durable and improving efficacy through 56 weeks and a favorable safety/tolerability profile.
Key results: 63.1% achieved vIGA-AD Clear/Almost Clear at Week 56; EASI-75 reached 71.9–76.0% at Week 56; median disease-control duration on twice-weekly proactive dosing ~238 days. Overall TEAEs were mostly mild/moderate; SAEs 3.2% (none treatment-related).
Arcutis (Nasdaq: ARQT) promoted Mas Matsuda to Executive Vice President, Chief Legal Officer, and Corporate Secretary effective March 5, 2026. He will continue to lead legal, compliance, governance, IP protection and support corporate transactions as the company commercializes the ZORYVE portfolio and advances its pipeline.
Mr. Matsuda joined Arcutis in January 2022 and is credited with guiding the company through six FDA approvals of ZORYVE while scaling legal and compliance functions.
Arcutis (Nasdaq: ARQT) has begun enrolling the first participant in a Phase 1a/1b first‑in‑human study (ARQ-234-131) of ARQ-234, a CD200R agonist fusion protein for moderate to severe atopic dermatitis.
The double‑blind, randomized, placebo‑controlled study will assess safety and tolerability in single‑ascending and multiple‑ascending dose cohorts in healthy volunteers and adults with atopic dermatitis, plus a small proof‑of‑concept cohort. ARQ-234 is administered subcutaneously and is designed to selectively activate CD200R to modulate overactive immune responses.
Arcutis (Nasdaq: ARQT) announced management will present at the TD Cowen 46th Annual Health Care Conference in Boston, March 2-4, 2026. The company will host a Fireside Chat on March 2, 2026 at 1:50 p.m. ET.
The live webcast is available via the company Events page and a replay will remain accessible on the Arcutis website for 180 days following the conference.