Mirum Pharmaceuticals and Incyte Announce Positive Pivotal Phase 2 Results from PROGRESS Study of Zilurgisertib in Fibrodysplasia Ossificans Progressiva
Incyte and Mirum announced positive pivotal Phase 2 results for zilurgisertib in fibrodysplasia ossificans progressiva (FOP), showing an 81% reduction in new heterotopic ossification lesions and a 99.9% reduction in new lesion volume versus placebo. The FDA has accepted the New Drug Application for zilurgisertib under Priority Review, with a PDUFA target action date set for September 26, 2026.
Key figures
- Drug Name
- zilurgisertib
- Phase Of Trial
- Phase 2
- Pdufa date
- September 26, 2026
- Patients placebo arm
- 31
- Patients enrolled cohort 1
- 63
- Patients zilurgisertib arm
- 32
- New lesion reduction vs placebo
- 81%
- Total lesion volume change placebo
- 24.64 cm3
- New lesion volume reduction vs placebo
- 99.9%
- Total lesion volume change zilurgisertib
- -3.24 cm3
AI analysis
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