Shares in Arcutis Biotherapeutics (ARQT 2.08%) continued their excellent run in 2025 (up 96%) with another 9.3% rise in the week to Friday morning. This week's move comes as the Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Arcutis' Zoryve (roflumilast) cream. The development raises confidence that the company will be able to extract full value from Zoryve across various indications.
Arcutis and Zoryve
Arcutis is a medical dermatology company with a commercialized therapy, Zoryve, approved for three inflammatory dermatoses: atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. It's already approved in foam (better for hair-bearing areas) and cream (smooth areas), and in various concentrations, ranging from 0.3% to 0.05%.
NASDAQ: ARQT
Key Data Points
This week's news concerns the FDA's acceptance of an sNDA for Zoryve cream 0.3% for children aged two to five years with plaque psoriasis.
For reference, the pharmaceutical company has already obtained approval for Zoryve cream 0.3% to treat children aged 6 years and older with plaque psoriasis, and has also obtained approval for Zoryve 0.05% to treat children aged 2 to 5 years with atopic dermatitis. The FDA aims to complete the NDA review by June 29, 2026.
Image source: Getty Images.
Where next for Arcutis
The good news follows the recent excellent third-quarter results, which sent the stock soaring after management's sales outlook came in significantly ahead of market estimates, and Arcutis continues to try to expand the market potential for Zoryve.
