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WESTLAKE VILLAGE, Calif. - The U.S. Food and Drug Administration (FDA) has approved a new treatment for mild to moderate atopic dermatitis (AD), commonly known as eczema. Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), announced today that its once-daily, steroid-free cream, ZORYVE (roflumilast) 0.15%, is now authorized for use in adult and pediatric patients aged six years and older.
This approval marks the third FDA green light for an Arcutis product in the past two years. ZORYVE aims to provide rapid disease clearance and significant itch reduction. Clinical trials highlighted the cream's ability to deliver a substantial decrease in itch within 24 hours after initial application.
The efficacy of ZORYVE was supported by data from three Phase 3 studies, which included 1,337 participants with mild to moderate AD. The primary endpoint of IGA Success was met, demonstrating clear or almost clear skin in a significant number of patients at Week 4 compared to the vehicle. Notably, over 40% of patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 4.
Safety profiles from the trials indicated that ZORYVE was well tolerated, with the most common adverse reactions being headache, nausea, application site pain, diarrhea, and vomiting. No adverse reactions occurred in more than 2.9% of subjects.
Arcutis intends to make the cream available by the end of July through wholesaler and dermatology pharmacy channels. The company also offers patient support programs, including the ZORYVE® Direct Program and Arcutis Cares™, which aim to facilitate access and adherence to treatment.
AD affects approximately 9.6 million children and 16.5 million adults in the U.S. It is a chronic, relapsing inflammatory skin disease characterized by intense itchiness and rash. The FDA's approval of ZORYVE provides a new steroid-free option for patients and caregivers seeking long-term disease control.
This article is based on a press release statement from Arcutis Biotherapeutics, Inc.
In other recent news, Arcutis Biotherapeutics has reported a strong financial performance in the first quarter of 2024. The company announced net revenues of $21.6 million, marking a 59% growth from the previous quarter, primarily driven by its ZORYVE product lineup.
This includes the cream and foam variants which generated over 255,000 prescriptions from more than 12,500 unique prescribers. Moreover, Arcutis has raised $172 million in a secondary offering and entered a licensing agreement with Sato Pharmaceutical.
On a different note, Mizuho Securities reiterated its Outperform rating on Arcutis Biotherapeutics, following an update from the company regarding its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% intended for the treatment of atopic dermatitis.
The U.S. Food and Drug Administration (FDA) is currently finalizing the action letter for the sNDA, with no indication of an extension of the Prescription Drug User Fee Act (PDUFA) goal date, which is set for July 7, 2024.
These recent developments highlight Arcutis Biotherapeutics' progress in the market. Despite a more competitive market for ZORYVE cream in atopic dermatitis, the company maintains confidence in its growth throughout 2024, backed by a strong cash position of $404 million in cash and marketable securities at the end of the quarter.
InvestingPro Insights
Following the FDA's approval of ZORYVE, Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) has shown promising financial metrics that may interest investors. With a market capitalization of $1.17 billion, the company's growth trajectory is underscored by a staggering year-over-year revenue growth of 1545.18% as of Q1 2024, reflecting the potential market impact of their newly approved treatments.
Moreover, Arcutis has demonstrated a robust gross profit margin of 92.99% in the same period, indicating efficient management of production costs and profitability potential once sales of ZORYVE pick up.
While the P/E ratio stands at -3.83, indicating that the company is not currently profitable, the significant revenue growth and high gross profit margin suggest potential for future earnings improvements. Two InvestingPro Tips for Arcutis Biotherapeutics highlight that the company holds more cash than debt on its balance sheet and analysts have revised their earnings upwards for the upcoming period, reflecting a positive outlook on the company's financial health and future performance.
Investors looking to delve deeper into Arcutis Biotherapeutics' financials and future prospects can find more insights with an InvestingPro subscription. There are 11 additional InvestingPro Tips available for ARQT, offering a comprehensive analysis of the company's financial standing and market position. Use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, and unlock the full potential of informed investing.
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