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WESTLAKE VILLAGE, Calif. - Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a biopharmaceutical company with a market capitalization of $1.89 billion and impressive 46% stock appreciation over the past year, has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking to expand the use of ZORYVE cream 0.3% for treating plaque psoriasis in children as young as 2 years old.
If approved, ZORYVE would become the first topical PDE4 inhibitor indicated for plaque psoriasis in children down to age 2. The cream is currently approved for plaque psoriasis in patients 6 years and older.
The application is supported by data from a 4-week Maximal Usage Systemic Exposure study in children aged 2 to 5 years with plaque psoriasis, along with results from a long-term open-label study showing favorable safety and sustained efficacy.
"Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, who often present with disease on sensitive skin such as the face and intertriginous areas," said Adelaide Hebert, professor and chief of pediatric dermatology at UTHealth Houston. According to InvestingPro data, Arcutis maintains an impressive 89% gross profit margin, suggesting strong commercial potential for its products. Get access to 8 more exclusive ProTips and comprehensive analysis with an InvestingPro subscription.
Plaque psoriasis in young children frequently affects sensitive areas like the face and skin folds, creating challenges for long-term management. ZORYVE cream is a once-daily, steroid-free formulation without sensitizing ingredients like propylene glycol, polyethylene glycol, or fragrances.
"This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases," said Frank Watanabe, president and CEO at Arcutis.
The company stated in its press release that ZORYVE is currently the most prescribed branded topical therapy across three major inflammatory skin conditions: atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. With analysts setting price targets between $19 and $25, and three analysts recently revising earnings estimates upward, InvestingPro’s comprehensive research report provides detailed insights into the company’s growth trajectory and market position.
In other recent news, Arcutis Biotherapeutics reported its second-quarter 2025 earnings, surpassing both earnings per share (EPS) and revenue forecasts. The company posted an EPS of -$0.13, beating the forecast of -$0.17, and reported revenue of $81.5 million, which exceeded expectations by 11.26%. This marks a positive financial performance for Arcutis Biotherapeutics. Meanwhile, Palvella Therapeutics announced the appointment of David W. Osborne, Ph.D., as Chief Innovation Officer. Dr. Osborne brings over 25 years of experience in developing topical therapies for skin diseases. He was a co-founder of Arcutis Biotherapeutics and served as its Chief Technical Officer. These recent developments highlight key changes and achievements within the companies.
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