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LAS VEGAS - Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) announced Friday that new data from Phase 3 studies show its ZORYVE cream helped reduce sleep disruptions in individuals with atopic dermatitis aged 2 years and older. The company, currently valued at $2.41 billion, has demonstrated impressive growth with revenue surging 99.5% over the last twelve months. According to InvestingPro analysis, Arcutis maintains robust gross profit margins of 89.1%, indicating strong operational efficiency in its pharmaceutical development programs.
The data, presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas, demonstrated that once-daily ZORYVE cream 0.15% and 0.05% improved quality of life by reducing sleep disturbances across multiple patient-reported outcome measurements compared to vehicle treatment. Analysts maintain a bullish outlook on ARQT, with price targets ranging from $19 to $29, reflecting confidence in the company’s clinical developments. For deeper insights into Arcutis’s growth potential and comprehensive analysis, investors can access detailed Pro Research Reports available on InvestingPro.
The studies included INTEGUMENT-1 and INTEGUMENT-2 trials for patients aged 6 years and older using ZORYVE 0.15% cream, and INTEGUMENT-PED for children aged 2-5 years using ZORYVE 0.05% cream.
Additional long-term data from the 52-week INTEGUMENT-OLE extension trial showed that patients who achieved clear skin and switched to twice-weekly application maintained disease control for a median of 238 days in children aged 2-5 and 281 days in those 6 years and older.
"Sleep disruption is a persistent and often overlooked but very real daily burden for those impacted by atopic dermatitis, including young children and their families," said Mercedes E. Gonzalez, MD, medical director of Pediatric Skin Research, LLC and INTEGUMENT-PED clinical trial investigator.
The studies also showed ZORYVE cream reduced itch as measured by the Worst Itch Numeric Rating Scale, with improvements observed within 24 hours of the first application compared to vehicle treatment.
Treatment-related adverse events were reported in less than 6% of patients across the studies, with application-site pain occurring in approximately 1.5% of participants.
ZORYVE cream is a topical phosphodiesterase type 4 inhibitor indicated for the treatment of mild to moderate atopic dermatitis in adults and children.
The information in this article is based on a press release statement from Arcutis Biotherapeutics. The company’s stock has shown remarkable momentum, delivering a 148.28% return over the past year, with current trading at $20.08 suggesting slight undervaluation according to InvestingPro Fair Value metrics. InvestingPro subscribers have access to 12 additional key insights about ARQT, including detailed financial health scores and growth projections.
In other recent news, Arcutis Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) for its ZORYVE cream, intended to treat mild to moderate atopic dermatitis in children aged 2 to 5 years. This approval provides a non-steroid treatment option that can be used for any duration, offering an alternative to topical steroids for approximately 1.8 million children in the U.S. The ZORYVE cream demonstrated significant improvement in clinical trials, with about 40% of children achieving a 75% improvement in symptoms after four weeks. Additionally, Arcutis Biotherapeutics has submitted a supplemental New Drug Application to the FDA to expand the use of ZORYVE cream for treating plaque psoriasis in children as young as 2 years old. Meanwhile, Mizuho has raised its price target for Arcutis Biotherapeutics to $26.00 from $21.00, maintaining an Outperform rating, and increased its sales forecast for the ZORYVE franchise to approximately $89 million for the third quarter of 2025. In related personnel news, Palvella Therapeutics has appointed David W. Osborne, Ph.D., a co-founder of Arcutis Biotherapeutics, as its Chief Innovation Officer. Dr. Osborne has extensive experience in developing topical therapies, including ZORYVE cream and foam.
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