PDUFA Date
On September 19, 2025, the FDA will decide on the label expansion of Opzelura® (ruxolitinib cream) for pediatric atopic dermatitis in children aged 2–11.
The prior delay was purely due to CMC review, meaning the FDA needed more time to evaluate manufacturing and quality data. No safety or efficacy issues were raised, so the risk is considered procedural, not clinical.
The probability of a positive outcome is high.
Bull Case
Atopic dermatitis is among the most common chronic skin diseases in children. Current treatment relies heavily on steroid creams, which carry long-term safety drawbacks.
A pediatric approval would position Opzelura as the first steroid-free standard option for mild-to-moderate AD in kids, with sales potential rising from roughly $600M in 2025 toward $1.2B peak annually.
Incyte also benefits from Jakafi®, a blockbuster oral JAK inhibitor with $2.8B in 2024 sales, used in hematology for myelofibrosis, polycythemia vera, and graft-versus-host disease. Along with a solid cash position and ongoing share buybacks, this provides stability while Opzelura drives the next growth leg.
My Position
I currently hold a 4% allocation in Incyte. If shares drop from here, I plan to average down, especially if the PDUFA goes through as expected.