Incyte Corporation
06/22/2026 | Press release | Distributed by Public on 06/22/2026 05:01
Material Event (Form 8-K)
Item 8.01 Other Events.
Incyte Corporation (the "Company") today announced that it has reached an agreement with the Centers for Medicare & Medicaid Services ("CMS") to resolve the Company's litigation related to the application of Medicaid rebate rules to Opzelura® (ruxolitinib) cream. Under the agreement, CMS will not apply the line extension regulation to Opzelura as if it were a line extension of Jakafi® (ruxolitinib), and the Company has withdrawn its lawsuit challenging the regulations. The settlement was reached based on the unique facts of Opzelura and Jakafi.
The Company expects to record a one-time, non-cash benefit of approximately $246 million in the second quarter ending June 30, 2026, associated with the reversal of previously established accrual balances through March 31, 2026, related to liabilities associated with the potential application of the line extension regulations to Opzelura. The Company will no longer accrue for the potential application of the line extension regulations to Opzelura and expects an improvement to Opzelura's gross-to-net on a go-forward basis. The Company plans to update financial guidance to reflect the impact of the settlement during the next scheduled earnings release.
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