WESTLAKE VILLAGE, Calif. - The U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam, a treatment for scalp and body psoriasis, from Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for May 22, 2025.
Arcutis, a commercial-stage biopharmaceutical company, is developing ZORYVE foam as a once-daily therapy for adults and adolescents aged 12 and over. The product is a next-generation phosphodiesterase-4 (PDE4) inhibitor, a class of drugs with anti-inflammatory properties.
Clinical trials have shown that ZORYVE foam significantly improved signs and symptoms of psoriasis compared to a vehicle. The ARRECTOR Phase 3 trial, along with a Phase 2b study, demonstrated that 66.4% of patients treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 8, compared to 27.8% for the vehicle foam. For body psoriasis, 45.5% of patients reached Body-Investigator Global Assessment (B-IGA) Success with ZORYVE foam, versus 20.1% with the vehicle.
Moreover, the foam was well tolerated, with the most common adverse reactions being headache, diarrhea, nausea, and nasopharyngitis. Discontinuation rates due to adverse events were low and similar between the treatment and vehicle groups.
Plaque psoriasis, characterized by red, scaly skin plaques, affects approximately 9 million Americans, nearly half of whom experience scalp involvement. Scalp psoriasis can be particularly challenging to manage due to the difficulty of applying treatments through hair.
ZORYVE foam's unique formulation is designed to address this issue, potentially offering a new option for patients with scalp and body psoriasis. The product is already approved for other dermatological indications, including seborrheic dermatitis and plaque psoriasis.
As this information is based on a press release statement, it represents the company's claims regarding its product's efficacy and safety. The FDA's decision in May 2025 will determine whether ZORYVE foam will be available as a new treatment option for scalp and body psoriasis.
In other recent news, Arcutis Biotherapeutics has been making significant strides in the market. The company has reported strong second-quarter results in 2024, with net revenues reaching $30.9 million, marking a 43% increase in net product revenues compared to the first quarter. This growth has been largely driven by the significant prescription growth for its dermatology products, including ZORYVE cream and foam.
Furthermore, the company has announced the publication of results from two Phase 3 studies, INTEGUMENT-1 and INTEGUMENT-2, evaluating the efficacy and safety of ZORYVE cream in treating mild to moderate atopic dermatitis. The published data indicate that approximately 31% of participants achieved the primary efficacy endpoint of Investigator Global Assessment Success at Week 4, which is statistically significant compared to 14% for the placebo.
Analysts from Mizuho Securities, TD Cowen, and Jefferies have maintained a positive outlook on Arcutis, highlighting the strong sales performance of the Zoryve line. Jefferies has set a Buy rating on Arcutis shares, citing the company's potential for growth and estimating that Zoryve could achieve peak sales of $800 million.
The company is also initiating the launch of the cream for atopic dermatitis while filing a supplemental New Drug Application for the foam to be used on scalp and body psoriasis. These recent developments have been making headlines for Arcutis Biotherapeutics.
InvestingPro Insights
Amidst the anticipation of the FDA's decision on ZORYVE foam, Arcutis Biotherapeutics (NASDAQ:ARQT) presents a compelling profile from an investment standpoint. With a market capitalization of $1.13 billion, the company showcases remarkable revenue growth, having expanded by over 1032.9% in the last twelve months as of Q2 2024. This growth trajectory is reflected in the company's gross profit margin, which stands at an impressive 92.32%, indicating strong profitability potential for its product lines.
Investors and analysts tracking Arcutis are optimistic about the company's sales outlook, with analysts anticipating sales growth in the current year. This is particularly relevant as the company advances its pipeline, including ZORYVE foam. Furthermore, the company's financial health is underscored by the fact that it holds more cash than debt on its balance sheet, providing it with a solid foundation to manage its operations and invest in growth opportunities.
According to InvestingPro Tips, Arcutis is praised for its impressive gross profit margins, which could be indicative of robust operational efficiency and pricing power. However, it's important to note that analysts do not anticipate the company will be profitable this year, which could be a factor for investors to consider. For those looking for more in-depth analysis, there are additional tips available on InvestingPro's platform, providing further insights into Arcutis's financials and market performance.
With the next earnings date set for November 6, 2024, investors will be keen to follow Arcutis's performance closely. The company's stock is currently trading at $9.63, with a high return over the last year of 79.0%, signaling strong investor confidence. For more detailed analysis and further InvestingPro Tips, interested parties can visit https://www.investing.com/pro/ARQT.
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