Arcutis Nears FDA Decision On Roflumilast Cream For Atopic Dermatitis

(RTTNews) - Arcutis Biotherapeutics Inc. (ARQT), an early commercial-stage biopharmaceutical company specializing in immuno-dermatology, has a significant regulatory catalyst approaching.

The company has sought FDA approval for the expanded use of Roflumilast Cream 0.15% in treating atopic dermatitis (AD) in adults and children down to age 6. Roflumilast cream is a once-daily, steroid-free, phosphodiesterase-4 (PDE-4) inhibitor.

The FDA decision on Roflumilast Cream 0.15% is expected on July 7, 2024.

Roflumilast cream 0.3% was approved by the FDA for the treatment of plaque psoriasis in patients 12 years of age or older, under the brand name Zoryve, in July 2022. The following year, in October, it was approved for the expanded use in children ages 6 to 11 years.

Last December, Roflumilast topical foam, 0.3%, received FDA approval for the treatment of seborrheic dermatitis in individuals 9 years of age and older, under the brand name Zoryve.

In the first quarter of 2024, net product revenues for ZORYVE franchise were $21.6 million, with $15 million for ZORYVE cream 0.3% and $6.5 million for ZORYVE topical foam 0.3%. This compares with net product revenue of $2.8 million in the first quarter of 2023.

ARQT has traded in a range of $1.76 to $13.17 in the last 1 year. The stock closed Yesterday' s trading (July 2, 2024) at $9.30, down 2.72%