The FDA decision on the expanded labelling of Incyte Corp.’s (INCY) Opzelura cream for the treatment of children 2-11 years old with mild to moderate atopic dermatitis is expected on September 19, 2025.Opzelura cream is a topical Janus kinase (JAK) inhibitor that is already approved in the U.S. for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. It is also approved for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older.The net product revenue of Opzelura was $164 million in the second quarter of 2025, an increase of 35% over the year-ago period. The product is expected to generate net product revenue in the range of $630 million to $670 million for the full year 2025, compared to $508 million reported last year.INCY closed Wednesday’s (Aug.27, 2025) trading at $85.04, down 1.72%.