Why Arcutis Biotherapeutics (ARQT) Is Up 10.5% After FDA Filing to Expand ZORYVE for Children

• Arcutis Biotherapeutics recently submitted a supplemental New Drug Application to the FDA seeking to expand the use of ZORYVE cream 0.3% for treating plaque psoriasis in children as young as 2 years old, supported by data from recent pediatric studies.
• If approved, ZORYVE would be the first topical PDE4 inhibitor indicated for this age group, widening both its clinical and market reach.
• We'll explore how the potential to make ZORYVE available for younger children could influence Arcutis Biotherapeutics' growth narrative and market outlook.

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Arcutis Biotherapeutics Investment Narrative Recap

As a shareholder in Arcutis Biotherapeutics, the core thesis is the company’s ability to expand ZORYVE across untapped dermatology markets, targeting large populations and leveraging its differentiated safety profile. The recent sNDA seeking to extend ZORYVE cream to children as young as two is a meaningful milestone; its impact as a near-term catalyst hinges almost entirely on regulatory approval, as commercial success remains tightly linked to ZORYVE’s broader adoption. Heavy dependence on this franchise, however, remains the single largest business risk.

The FDA’s recent green light for ZORYVE foam 0.3% in scalp and body psoriasis stands out as especially relevant, further deepening the brand’s market presence and clinical value for a wide range of patients. Both announcements signal continued momentum in expanding indications, which is central to Arcutis’ revenue growth strategy.

Yet, in contrast to the growth story, investors should be aware of the risks from concentrated reliance on one product…

Read the full narrative on Arcutis Biotherapeutics (it's free!)

Arcutis Biotherapeutics is projected to reach $676.8 million in revenue and $237.0 million in earnings by 2028. This outlook is based on forecasted annual revenue growth of 37.0%, with earnings expected to rise by $330.3 million from the current -$93.3 million level.

Uncover how Arcutis Biotherapeutics' forecasts yield a $21.86 fair value, a 27% upside to its current price.

Exploring Other Perspectives

Six members of the Simply Wall St Community valued Arcutis between US$18.04 and US$54.07 per share before the latest regulatory update. With so many contrasting outlooks, business concentration around ZORYVE remains top of mind for your future research.

Explore 6 other fair value estimates on Arcutis Biotherapeutics - why the stock might be worth just $18.04!

Build Your Own Arcutis Biotherapeutics Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Arcutis Biotherapeutics research is our analysis highlighting 3 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Arcutis Biotherapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Arcutis Biotherapeutics' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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