Zilurgisertib (licensed to Mirum; MIRM holds the NDA) is a Incyte Corp, Mirum Pharmaceuticals, Inc. program in Fibrodysplasia ossificans progressiva (FOP). Its PDUFA date is Sep 26, 2026, the FDA's goal date to complete review of the application. Every date links its source.
INCY catalyst hub · MIRM catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Fibrodysplasia ossificans progressiva (FOP). Sponsor: Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM). Review status: The FDA accepted the NDA for zilurgisertib in FOP under Priority Review with a PDUFA date of September 26, 2026. Mirum licensed zilurgisertib from Incyte for development and commercialization globally. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 2 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
Zilurgisertib (licensed to Mirum; MIRM holds the NDA)'s PDUFA date is Sep 26, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Zilurgisertib (licensed to Mirum; MIRM holds the NDA) is in our archive yet.
In our records Zilurgisertib (licensed to Mirum; MIRM holds the NDA) is under review or in development for Fibrodysplasia ossificans progressiva (FOP).
Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.