Mirum Pharmaceuticals and Incyte Announce Positive Pivotal Phase 2 Results from PROGRESS Study of Zilurgisertib in Fibrodysplasia Ossificans Progressiva

Mirum Pharmaceuticals and Incyte Announce Positive Pivotal Phase 2 Results from PROGRESS Study of Zilurgisertib in Fibrodysplasia Ossificans Progressiva

- Cohort 1 results presented at ENDO 2026 demonstrate meaningful reductions in total heterotopic ossification (HO) lesion volume, new HO lesions and flare activity in adolescents and adults with FOP

- U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zilurgisertib in FOP under Priority Review

Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced pivotal Phase 2 results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral activin receptor-like kinase 2 (ALK2) inhibitor, in adolescents and adults (≥12 years of age) with fibrodysplasia ossificans progressiva (FOP). Results were shared in a late-breaking rapid-fire presentation at ENDO 2026, the Endocrine Society’s annual meeting.

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