Mirum Pharmaceuticals and Incyte Announce Pivotal Late-Breaking Results for Zilurgisertib in Fibrodysplasia Ossificans Progressiva Accepted for Presentation at ENDO 2026

▤ Summary

Mirum Pharmaceuticals and Incyte announced pivotal Phase 2 results for zilurgisertib in fibrodysplasia ossificans progressiva ahead of its presentation at ENDO 2026. The data come from Cohort 1 of the placebo-controlled PROGRESS study and supported the NDA filed with the FDA. Mirum licensed worldwide rights to zilurgisertib from Incyte in April 2026, and the companies said they are advancing the program toward the September 26, 2026 PDUFA date. The article also outlines the drug’s mechanism, the study design, and both companies’ broader rare-disease and biopharmaceutical portfolios.

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