FDA Extends Review for Incyte Ruxolitinib Cream Pediatric Use

The FDA has extended the review period for Incyte's supplemental New Drug Application for ruxolitinib cream (Opzelura) to treat mild to moderate atopic dermatitis in children aged 2 to 11, pushing the decision deadline to September 19, 2025. This extension allows the FDA additional time to evaluate further chemistry, manufacturing, and controls data submitted by Incyte in response to an information request. Incyte expressed confidence in the potential of ruxolitinib cream as a non-steroidal topical treatment option for pediatric patients, based on positive results from the Phase 3 TRuE-AD3 study which met its primary and secondary endpoints without new safety concerns. Despite the delay, analysts maintain an overall positive outlook on Incyte's stock, with an average price target suggesting an 11% upside and brokerage firms rating it as 'Outperform.' The GF Value metric further indicates a potential upside of nearly 44% from the current stock price. Incyte continues to work closely with the FDA to provide all necessary information to complete the review process.