Shares of Arcutis Biotherapeutics Inc. (ARQT) have nearly doubled in value over the past year, thanks to the success of its flagship product ZORYVE, which has been developed as a portfolio of innovative topical therapies that is redefining the treatment of chronic inflammatory skin diseases and demonstrating strong, sustainable commercial momentum across all strengths and indications.
ZORYVE is a next-generation small molecule inhibitor of phosphodiesterase-4 (PDE4) that has been implicated in a wide range of inflammatory diseases. It is available in cream and foam formulations at multiple strengths, has been approved for several indications, and is being explored for further uses.
ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.05%, is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older and for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.
The company has sought FDA approval to expand the label of ZORYVE cream 0.3% as a topical treatment of plaque psoriasis to include children 2 to 5 years old, and a decision is due on June 29, 2026.
A phase 2 open-label clinical study, which is evaluating the safety and tolerability of ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis, dubbed INTEGUMENT-INFANT, is ongoing, with topline data expected this quarter.
The company is also exploring ZORYVE foam 0.3% in Phase 2 proof-of-concept studies for the treatment of patients with vitiligo, as well as patients with hidradenitis suppurativa.
ZORYVE made its market debut in August 2022, following FDA approval of its 0.3% cream formulation for the treatment of plaque psoriasis, including psoriasis in the intertriginous areas (e.g. groin or axillae), in individuals 12 years of age or older. Since then, the ZORYVE franchise has continued to expand through additional formulations, new indications, and ongoing label expansions, broadening its reach across inflammatory skin diseases.
Since its launch in August 2022, ZORYVE has demonstrated strong and accelerating commercial momentum. Product revenue grew from a modest $3.7 million in 2022, reflecting a partial launch year, to about $59.6 million in 2023, driven by physician adoption and the demand for new treatment options. Growth further accelerated in 2024, with revenue reaching roughly $166.5 million, driven by broader adoption, additional formulations, and label expansions. This momentum continued into 2025, with ZORYVE generating $244.6 million in net product revenue in the first nine months alone, underscoring its rapid uptake and strengthening position in the treatment of inflammatory skin diseases.
The full year 2025 financial results are expected to be reported next month.
Looking further ahead to the full year 2026, Arcutis anticipates net product revenue of between $455 million and $470 million. Peak sales of ZORYVE are estimated to reach $2.6?billion to $3.5?billion.
According to the company, the market for ZORYVE in the dermatology speciality is both significant and achievable. Substantial growth opportunities remain as ZORYVE continues to drive expansion, and with its differentiated clinical and safety profile, the product has the potential to displace topical corticosteroids.
Is ZORYVE the only product that Arcutis is focusing on?
No, the company's pipeline also includes ARQ-234, a fusion protein that serves as an agonist with high selectivity and potency for the CD200 receptor (CD200R).
In recent preclinical and clinical studies, CD200R has been validated as a target in atopic dermatitis with evidence of durable biologic response, even after discontinuation of treatment.
The company is preparing to initiate a phase 1 study of ARQ-234 in atopic dermatitis.
Cash position
As of September 30, 2025, the company's cash, cash equivalents, restricted cash, and marketable securities were $191.4 million.
We first profiled Arcutis on our site on December 14, 2023, when the stock was trading around $2.42. On January 10, 2025, when we revisited the stock, it was at $14.90.
In the last 1 year, the stock has traded in a range of $11.13 to $31.77. ARQT closed yesterday's trading at $30.20, up 4.14%.
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