News

Arcutis Biotherapeutics Receives FDA Approval for Expanded Use of Zoryve Cream in Children

James L. Flint

• October 06, 2023

Shares of Arcutis Biotherapeutics surged in premarket trading after the biopharmaceutical company announced that it had received expanded approval from the Food and Drug Administration (FDA) for its Zoryve cream. The cream is now approved for the topical treatment of plaque psoriasis in children ages 6 to 11.

Arcutis shares, which closed at an all-time low of $4.43 on Thursday, saw a remarkable 9.5% increase to reach $4.85 in premarket trading. However, despite this positive development, the stock has experienced a decline of approximately 70% throughout the year leading up to Thursday.

This approval is significant as it provides children with a steroid-free topical treatment option for the most prevalent form of psoriasis, including psoriasis occurring in skin folds, also known as intertriginous areas.

Notably, the FDA had previously approved Zoryve for the topical treatment of plaque psoriasis in patients aged 12 and older. Furthermore, it is currently evaluating the cream for the treatment of seborrheic dermatitis in individuals aged 9 and up, with a target action date of December 16th.

It is indeed an exciting milestone for Arcutis Biotherapeutics, who continues to make strides in providing effective solutions for individuals affected by various skin conditions.