Arcutis Releases Zoryve Study Data Showing Good Safety Profile
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 10 2026
0mins
Should l Buy ARQT?
Arcutis Biotherapeutics announced that Pediatric Dermatology published data from the Phase 3 open-label extension study evaluating once-daily Zoryve cream 0.05% in children aged 2 to 5 years with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of Zoryve cream 0.05% in October 2025, demonstrated that Zoryve cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment. The primary endpoint of the OLE study was safety. Treatment-Emergent Adverse Events were reported for 280 participants, and most events were mild or moderate. The most common TEAEs included upper respiratory tract infection in 8.7% of participants, nasopharyngitis in 5.0%, and pyrexia in 5.0%. Gastrointestinal adverse events were reported for 4.4% of participants, most commonly vomiting and diarrhea. Serious Adverse Events occurred in 18 participants, none of which were considered treatment-related. Overall, 14 of 562 participants experienced treatment-related AEs, and 4 participants experienced application site pain.
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Analyst Views on ARQT
Wall Street analysts forecast ARQT stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 22.380
Low
30.00
Averages
32.00
High
37.00
Current: 22.380
Low
30.00
Averages
32.00
High
37.00
About ARQT
Arcutis Biotherapeutics, Inc. is a commercial-stage medical dermatology company. The Company is focused on developing and commercializing treatments for dermatological diseases with high-unmet medical needs. Its portfolio is comprised of topical and systemic treatments with potential to treat immune-mediated dermatological diseases and conditions. Its lead product, ZORYVE, is for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas, in individuals 12 years of age or older. The ZORYVE is also indicated for topical treatment of mild to moderate atopic dermatitis. ZORYVE cream is a once-daily topical formulation of roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor. The Company’s pipeline includes ARQ-255, ARQ-252, and ARQ-234. Its ARQ-255 is being developed for the treatment of alopecia areata. ARQ-252 is an alternative topical cream formulation of ivarmacitinib that the Company is developing for chronic hand eczema and vitiligo.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
ZORYVE® Cream Shows Positive Results in Infant Eczema Treatment
- Clinical Trial Results: The INTEGUMENT-INFANT Phase 2 trial demonstrated that ZORYVE® (roflumilast) cream 0.05% significantly improved mild to moderate atopic dermatitis symptoms in infants aged 3 to 24 months, with 34.4% of participants achieving effective improvement after four weeks, highlighting the drug's therapeutic potential.
- Rapid Relief Effects: Caregivers reported that nearly half of the infants experienced significant itch relief within 10 minutes of applying ZORYVE cream, providing crucial psychological comfort for both infants and their families, indicating the drug's practical value in clinical settings.
- Safety Assessment: Among 101 participants, ZORYVE cream exhibited good safety and tolerability, with ≥97.9% of infants experiencing no application site irritation over four weeks, and only one participant discontinued due to an adverse event, demonstrating the drug's favorable profile in the infant population.
- Future Development Plans: Arcutis plans to submit a supplemental New Drug Application for ZORYVE cream 0.05% in infants aged 3 to <24 months in Q2 2026, which will further solidify its market position in atopic dermatitis treatment and provide safer, more effective options for this vulnerable population.
See More
Baron Health Care Fund Reports Strong Q4 2025 Performance
- Quarterly Growth: For the quarter ending December 31, 2025, the Baron Health Care Fund increased by 13.10%, significantly outperforming the Russell 3000 Health Care Index's 11.92% and the Russell 3000 Index's 2.40%, indicating strong performance in the healthcare sector.
- Key Contributors: Companies such as Eli Lilly, Cidara Therapeutics, and Argenx SE were major contributors this quarter, reflecting ongoing momentum in GLP-1 therapies and innovation in biotechnology, which drove the fund's gains.
- Portfolio Adjustments: The fund added seven new positions and exited ten during the quarter, bringing the total number of positions to 43, demonstrating its agile investment strategy in response to market changes.
- Risk Management Actions: The fund reduced its positions in Stryker and Boston Scientific due to valuation concerns while also decreasing its stake in Arcellx to manage risks associated with increasing competition and regulatory challenges, showcasing its responsiveness to market dynamics.
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Arcutis to Present at TD Cowen Health Care Conference in Boston
- Conference Participation: Arcutis Biotherapeutics will present at the TD Cowen 46th Annual Health Care Conference in Boston on March 2, 2026, at 1:50 PM ET, highlighting its innovations in immuno-dermatology.
- Webcast Access: The conference webcast will be accessible via the 'Events' section of the company's website, with a replay available for 180 days post-conference, allowing investors and the public to review the presentation.
- Company Overview: Arcutis is a commercial-stage biopharmaceutical company focused on developing innovative therapies for immune-mediated dermatological diseases, boasting a portfolio of advanced targeted topicals approved for three major inflammatory skin conditions.
- Forward-Looking Statements: The press release contains forward-looking statements based on the company's current beliefs and expectations, which may be subject to various known and unknown risks that could materially affect actual results.
See More
Arcutis (ARQT) Q4 2025 Earnings Call Transcript
See More
Arcutis Biotherapeutics Q4 Earnings Exceed Expectations
- Strong Earnings Report: Arcutis Biotherapeutics reported a Q4 GAAP EPS of $0.13, beating expectations by $0.03, indicating a sustained improvement in profitability that boosts investor confidence.
- Significant Revenue Growth: The company achieved Q4 revenue of $129.5 million, representing an 81.6% year-over-year increase and exceeding market expectations by $16.47 million, highlighting strong demand and sales performance for its products.
- Positive Market Reaction: Following the earnings beat, Arcutis's stock price experienced a notable increase, reflecting investor optimism regarding the company's future growth potential, which may attract more institutional investors.
- Strategic Growth Outlook: With improved revenue and profitability, Arcutis is poised to further expand its market share in the biopharmaceutical sector, particularly in dermatological treatments, enhancing its competitive edge.
See More
Max Homa Shares Journey with Seborrheic Dermatitis
- Patient Advocacy Campaign: Professional golfer Max Homa joins Arcutis' 'Free to Be Me' campaign to encourage the 10 million Americans living with seborrheic dermatitis to seek long-term treatment options, raising awareness about the condition.
- Significant Treatment Outcomes: ZORYVE® foam 0.3% demonstrated in clinical trials that 77% of users achieved clear skin within 8 weeks, compared to 53% in the control group, highlighting its effectiveness in treating seborrheic dermatitis.
- Safety and Tolerability: Common side effects of ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%), indicating its safety for long-term use across a broad patient population.
- Industry Recognition: ZORYVE was awarded the 2025 'Best of Beauty Breakthrough Award' and received recognition from the National Psoriasis Foundation, further solidifying its leadership position in dermatological treatments and enhancing market acceptance.
See More
ZORYVE® Cream Shows Positive Results in Infant Eczema Treatment
- Clinical Trial Results: The INTEGUMENT-INFANT Phase 2 trial demonstrated that ZORYVE® (roflumilast) cream 0.05% significantly improved mild to moderate atopic dermatitis symptoms in infants aged 3 to 24 months, with 34.4% of participants achieving effective improvement after four weeks, highlighting the drug's therapeutic potential.
- Rapid Relief Effects: Caregivers reported that nearly half of the infants experienced significant itch relief within 10 minutes of applying ZORYVE cream, providing crucial psychological comfort for both infants and their families, indicating the drug's practical value in clinical settings.
- Safety Assessment: Among 101 participants, ZORYVE cream exhibited good safety and tolerability, with ≥97.9% of infants experiencing no application site irritation over four weeks, and only one participant discontinued due to an adverse event, demonstrating the drug's favorable profile in the infant population.
- Future Development Plans: Arcutis plans to submit a supplemental New Drug Application for ZORYVE cream 0.05% in infants aged 3 to <24 months in Q2 2026, which will further solidify its market position in atopic dermatitis treatment and provide safer, more effective options for this vulnerable population.
See More
Baron Health Care Fund Reports Strong Q4 2025 Performance
- Quarterly Growth: For the quarter ending December 31, 2025, the Baron Health Care Fund increased by 13.10%, significantly outperforming the Russell 3000 Health Care Index's 11.92% and the Russell 3000 Index's 2.40%, indicating strong performance in the healthcare sector.
- Key Contributors: Companies such as Eli Lilly, Cidara Therapeutics, and Argenx SE were major contributors this quarter, reflecting ongoing momentum in GLP-1 therapies and innovation in biotechnology, which drove the fund's gains.
- Portfolio Adjustments: The fund added seven new positions and exited ten during the quarter, bringing the total number of positions to 43, demonstrating its agile investment strategy in response to market changes.
- Risk Management Actions: The fund reduced its positions in Stryker and Boston Scientific due to valuation concerns while also decreasing its stake in Arcellx to manage risks associated with increasing competition and regulatory challenges, showcasing its responsiveness to market dynamics.
See More
Arcutis to Present at TD Cowen Health Care Conference in Boston
- Conference Participation: Arcutis Biotherapeutics will present at the TD Cowen 46th Annual Health Care Conference in Boston on March 2, 2026, at 1:50 PM ET, highlighting its innovations in immuno-dermatology.
- Webcast Access: The conference webcast will be accessible via the 'Events' section of the company's website, with a replay available for 180 days post-conference, allowing investors and the public to review the presentation.
- Company Overview: Arcutis is a commercial-stage biopharmaceutical company focused on developing innovative therapies for immune-mediated dermatological diseases, boasting a portfolio of advanced targeted topicals approved for three major inflammatory skin conditions.
- Forward-Looking Statements: The press release contains forward-looking statements based on the company's current beliefs and expectations, which may be subject to various known and unknown risks that could materially affect actual results.
See More
Arcutis (ARQT) Q4 2025 Earnings Call Transcript
See More
Arcutis Biotherapeutics Q4 Earnings Exceed Expectations
- Strong Earnings Report: Arcutis Biotherapeutics reported a Q4 GAAP EPS of $0.13, beating expectations by $0.03, indicating a sustained improvement in profitability that boosts investor confidence.
- Significant Revenue Growth: The company achieved Q4 revenue of $129.5 million, representing an 81.6% year-over-year increase and exceeding market expectations by $16.47 million, highlighting strong demand and sales performance for its products.
- Positive Market Reaction: Following the earnings beat, Arcutis's stock price experienced a notable increase, reflecting investor optimism regarding the company's future growth potential, which may attract more institutional investors.
- Strategic Growth Outlook: With improved revenue and profitability, Arcutis is poised to further expand its market share in the biopharmaceutical sector, particularly in dermatological treatments, enhancing its competitive edge.
See More
Max Homa Shares Journey with Seborrheic Dermatitis
- Patient Advocacy Campaign: Professional golfer Max Homa joins Arcutis' 'Free to Be Me' campaign to encourage the 10 million Americans living with seborrheic dermatitis to seek long-term treatment options, raising awareness about the condition.
- Significant Treatment Outcomes: ZORYVE® foam 0.3% demonstrated in clinical trials that 77% of users achieved clear skin within 8 weeks, compared to 53% in the control group, highlighting its effectiveness in treating seborrheic dermatitis.
- Safety and Tolerability: Common side effects of ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%), indicating its safety for long-term use across a broad patient population.
- Industry Recognition: ZORYVE was awarded the 2025 'Best of Beauty Breakthrough Award' and received recognition from the National Psoriasis Foundation, further solidifying its leadership position in dermatological treatments and enhancing market acceptance.
See More
