Seamus Fernandez

Serge Belanger

Uy Ear

Douglas Tsao

Kambiz Yazdi

Vikram Purohit

Tyler Van Buren

Andrew Tsai

Ikenna Onwe

Judah Frommer

Richard Law

- Arcutis Biotherapeutics announced that the FDA has approved ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children ages 2 to 5.  **[1787306_e5f3d185fc264b8794e9489be68ae28e_0]** **[1787306_e5f3d185fc264b8794e9489be68ae28e_1]** 
- This approval represents the **sixth FDA approval for the ZORYVE portfolio** in just over three years.  **[1787306_e5f3d185fc264b8794e9489be68ae28e_0]** **[1787306_e5f3d185fc264b8794e9489be68ae28e_2]** 
- The commercial product is expected to be available by the **end of October 2025** and targets approximately **1.8 million children** in the U.S. who are topically treated for atopic dermatitis.  **[1787306_e5f3d185fc264b8794e9489be68ae28e_0]** **[1787306_e5f3d185fc264b8794e9489be68ae28e_1]** **[1787306_e5f3d185fc264b8794e9489be68ae28e_2]** 
- Clinical trials demonstrated rapid and effective relief, with approximately **40% of children achieving a 75% improvement** from baseline in eczema severity within four weeks.  **[1787306_e5f3d185fc264b8794e9489be68ae28e_1]**

Arcutis Biotherapeutics Receives FDA Approval for ZORYVE Cream 0.05% for Pediatric Atopic Dermatitis

- Arcutis Biotherapeutics' lead product, **ZORYVE**, a topical PDE4 inhibitor, is approved for **four different diseases** and has been on the market for about **three years**, with **80% of commercial lives having access**.  **[1787306_tx_377390_0]** **[1787306_tx_377390_2]** 
- The company recently launched **ZORYVE Foam 0.3% for scalp and body psoriasis in June** and anticipates an expansion of the atopic dermatitis label in **October**.  **[1787306_tx_377390_0]** **[1787306_tx_377390_3]** 
- Arcutis reported **Q2 sales up 28% versus Q1** and expects **Q3 net sales to be higher than Q2**, with a projected return to strong growth in Q4.  **[1787306_tx_377390_2]** **[1787306_tx_377390_3]** 
- The company maintains its guidance to be **cash flow positive in 2026**, with ZORYVE's growth expected to fuel future lifecycle management and pipeline investments.  **[1787306_tx_377390_6]** 
- Beyond ZORYVE, the pipeline includes **ARQ-234**, a novel checkpoint agonist biologic for atopic dermatitis, which recently opened its IND.  **[1787306_tx_377390_0]**

Arcutis Biotherapeutics Discusses ZORYVE Performance and 2026 Cash Flow Positive Outlook

Arcutis Biotherapeutics (ARQT)