Bullish indicating open at $55-$60, IPO prices at $37
WESTLAKE VILLAGE, Calif. - The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05% and has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025. If approved, ZORYVE cream 0.05% will become a new treatment option for children aged 2 to 5 with mild to moderate atopic dermatitis (AD), a condition affecting approximately 1.8 million children in the United States. According to InvestingPro data, Arcutis has demonstrated impressive revenue growth of 183% over the last twelve months, suggesting strong market potential for its treatments.
Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), a commercial-stage biopharmaceutical company, announced the FDA’s acceptance of the application, which is supported by positive efficacy and safety data from a pivotal Phase 3 trial, a long-term extension study, and a Phase 1 pharmacokinetic study.
The clinical trials demonstrated that ZORYVE cream 0.05% significantly improved the symptoms of AD in children, including a reduction in itchiness and skin rash. The treatment was well-tolerated with a safety profile consistent with that observed in adults and older pediatric subjects treated with ZORYVE cream 0.15% for the same condition. With an industry-leading gross profit margin of 90%, InvestingPro analysis reveals the company’s strong operational efficiency. InvestingPro subscribers have access to 8 additional key insights about ARQT’s financial performance and market position.
The pivotal INTEGUMENT-PED Phase 3 trial enrolled 652 children and showed significant improvements as early as the first week of treatment. By the fourth week, 25.4% of children treated with ZORYVE cream achieved vIGA-AD Success, defined as a score of ’Clear’ or ’Almost Clear’ with a 2-grade improvement from baseline, compared to 10.7% of children treated with a non-medicated vehicle.
Frank Watanabe, president and CEO of Arcutis, emphasized the potential of ZORYVE cream to provide an alternative to steroids and advance the standard of care for young children living with AD. The company is committed to addressing the needs of individuals with immune-mediated dermatological diseases and conditions.
Atopic dermatitis is a chronic, genetically predisposed, relapsing inflammatory skin disease that can cause a red, intensely itchy rash anywhere on the body. The disease presents differently across various age groups and can significantly impact the quality of life for both children and their caregivers.
The information for this article is based on a press release statement from Arcutis Biotherapeutics, Inc.
In other recent news, Arcutis Biotherapeutics Inc (NASDAQ:ARQT). reported its fourth-quarter 2024 earnings, showcasing a notable earnings per share (EPS) beat with a reported EPS of -$0.09, surpassing the forecasted -$0.28. The company’s revenue for the quarter reached $71.3 million, significantly exceeding the anticipated $54.72 million, marking a 413% year-over-year increase. The Zoryve franchise sales contributed $69.4 million to this revenue, outperforming previous estimates due to a one-time reduction in product return reserves. Mizuho (NYSE:MFG) Securities responded to these results by raising Arcutis’ stock price target to $21 from $20, maintaining an Outperform rating, which reflects their confidence in the company’s performance and future growth prospects.
Mizuho also revised its sales forecast for the Zoryve franchise, projecting 2025 sales to reach approximately $299 million, up from the previous estimate of $277 million and ahead of the $289 million market consensus. Arcutis management expressed comfort with the market consensus forecast of $289 million, indicating potential for further upside. The company remains optimistic about its growth trajectory, aiming for an annual revenue run rate of about $250 million by the end of 2025. Arcutis’ management highlighted the successful product launches and expanded market reach as key drivers of this growth. These developments, alongside the company’s strategic plans, have positioned Arcutis as a strong player in the dermatology sector.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.