INCY PDUFA Date: Atebrioz (zilurgisertib) Page updated October 3, 2026 · next FDA decision on the calendar · Data as of Oct 11, 2026 9:31 PM ET FDA decision Approved (announced September 25, 2026) · INCYTE CORP
Key facts FDA decision Approved (announced September 25, 2026)
FDA goal date 2026-09-26
Drug / candidate zilurgisertib
Company INCYTE CORP
Market-cap tier Large
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See the full 2026 PDUFA calendar → All September 2026 PDUFA dates → FAQ What did the FDA decide on INCY's zilurgisertib? The FDA decided INCY's (INCYTE CORP) application for zilurgisertib on September 25, 2026: Approved (the sponsor's announcement date; the filing does not state the day the FDA acted). The FDA goal date for this application was 2026-09-26. Verify against the linked primary source.
What is INCY's drug zilurgisertib? zilurgisertib is INCYTE CORP's drug, approved by the FDA on September 25, 2026.
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