Mirum Pharmaceuticals and Incyte Announce Pivotal Late-Breaking Results for Zilurgisertib in Fibrodysplasia Ossificans Progressiva Accepted for Presentation at ENDO 2026
Incyte and Mirum Pharmaceuticals announced that pivotal Phase 2 results for zilurgisertib in fibrodysplasia ossificans progressiva (FOP) will be presented at ENDO 2026. The late-breaking presentation covers Cohort 1 of the placebo-controlled PROGRESS study, which formed the basis of the New Drug Application (NDA) submitted to the FDA.
Key figures
- Drug Name
- zilurgisertib
- Phase Of Trial
- Phase 2
- Cohort
- Cohort 1 (patients 12 years and older)
- Dosage
- 100 mg once daily
- Pdufa date
- September 26, 2026
- Study name
- PROGRESS
- Treatment duration
- 24-week double-blind treatment period
- Us patient population
- 300
- Global patient population
- 900
AI analysis
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