The late-breaking rapid-fire presentation will include results from Cohort 1 of the placebo-controlled PROGRESS study, which enrolled patients 12 years of age and older and formed the basis of the New Drug Application (NDA) for zilurgisertib to the U.S. Food and Drug Administration (FDA).
In April 2026, Mirum entered into an exclusive license agreement with Incyte for worldwide rights to zilurgisertib.
"ENDO 2026 is an important milestone for the zilurgisertib FOP program as we share pivotal results from the PROGRESS study in patients living with this debilitating disease," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development at Incyte. "These data add to the growing clinical understanding of zilurgisertib's potential in FOP as Incyte and Mirum continue to advance toward the FDA's Priority Review PDUFA date of September 26, 2026."
"FOP is a devastating, progressive disease that profoundly impacts patients and families," said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. "At Mirum, in partnership with Incyte, we are committed to advancing zilurgisertib with urgency as we work toward potentially bringing a needed new treatment option to people living with FOP."
Congress Presentation
Additional details regarding the presentation are as follows:
| Abstract # | ORF37-04 |
| Title | Zilurgisertib in Patients with Fibrodysplasia Ossificans Progressiva: Interim Results from the PROGRESS Study |
| Date/Time | Sunday, June 14, 3:30-4:15 pm CT |