Incyte Corporation has raised its full-year 2026 Opzelura net sales guidance to between $1.05 billion and $1.1 billion following a landmark settlement with the Centers for Medicare & Medicaid Services.
The agreement resolves a long-running dispute over whether Medicaid rebate line extension rules should apply to Opzelura, known generically as ruxolitinib cream, as if it were a line extension of Jakafi.
Under the terms of the settlement, CMS agreed it will not apply the line extension regulation to Opzelura as though it were derived from Jakafi, Incyte’s established ruxolitinib tablet therapy.
In exchange, Incyte withdrew its lawsuit challenging the regulations, with the resolution grounded in what the company described as the unique facts of both Opzelura and Jakafi.
The financial impact of the settlement was immediately significant, with Incyte recording a one-time, non-cash benefit of $246 million in the second quarter of 2026 tied to the reversal of previously established accrual balances through March 31, 2026.
Opzelura net sales surged 173% to $450 million in the second quarter, though excluding the one-time accounting benefit, underlying sales rose 24% to $204 million, reflecting genuine demand growth for the treatment.
The total estimated incremental impact on Opzelura net sales for the full year 2026 is projected at between $300 million and $310 million, incorporating both the accrual reversal and an improved gross-to-net profile going forward.
Incyte’s broader performance was equally strong, with the company reporting $1.49 billion in total net product sales for the second quarter, a 40% increase year over year across its marketed portfolio.
Chief Executive Bill Meury noted on the earnings call that excluding the $246 million one-time benefit, total net sales still increased 17% year over year, underlining the underlying strength of the company’s commercial business.
The company also lifted its full-year 2026 total net sales guidance to a range of $5.13 billion to $5.26 billion, up sharply from its previous forecast of between $4.77 billion and $4.94 billion.
Hematology and oncology net sales guidance for the full year was also revised upward, with Incyte now expecting revenues of between $860 million and $890 million from that segment.
Looking beyond the US, Incyte anticipates a final European Commission decision on Opzelura for moderate atopic dermatitis during the third quarter, following a positive opinion from the Committee for Medicinal Products for Human Use in June.
Approval in Europe would open a significant new market for Opzelura and further strengthen the drug’s position as a key commercial pillar for Incyte heading into the second half of 2026.