CHMP positive opinion for Opzelura in moderate atopic dermatitis lifts Incyte
CHMP positive opinion for Opzelura in moderate atopic dermatitis lifts Incyte shares 6.83%
- Incyte announced CHMP/EMA positive opinion recommending Opzelura (ruxolitinib cream) approval for adults with moderate AD where topical corticosteroids or calcineurin inhibitors are inadequate.
- Recommendation based on pivotal Phase 3 trials demonstrating safety and efficacy of the JAK inhibitor cream.
- News released June 26, 2026, directly triggering intraday surge and elevated trading volume.
- Expands Incyte's dermatology portfolio in Europe, building on prior Opzelura approvals and recent pipeline wins like Japan Minjuvi approval (June 19) and zilurgisertib data.
- Viewed as de-risking non-Jakafi revenue growth ahead of potential EU approval and launch.
- Fits pattern of positive pipeline momentum; analysts had highlighted Opzelura EU AD as 2026 catalyst.
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