Atebrioz (zilurgisertib) is a Incyte Corp, Mirum Pharmaceuticals, Inc. program in Fibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification. 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), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification. Sponsor: Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM). Review status: NDA approved with Fast Track, Priority Review and Orphan Drug designations (FDA notice). 100 mg orally once daily. The FDA issued a Rare Pediatric Disease Priority Review Voucher to Incyte. Incyte developed zilurgisertib and licensed it to Mirum for worldwide development and commercialization; an EU marketing authorization application is under review. Efficacy: PROGRESS Cohort 1, 63 patients, mean total new HO volume -3.2 cm3 on Atebrioz vs +24.6 cm3 on placebo at week 24. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 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.
No upcoming catalyst is on our calendar for Atebrioz (zilurgisertib); no FDA decisions are on record below.
No FDA decision for Atebrioz (zilurgisertib) is in our archive yet.
In our records Atebrioz (zilurgisertib) is under review or in development for Fibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification.
Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.