MIRM, INCY Report Positive Rare Disease Data as FDA Begins NDA Review (Revised)

Mirum and Incyte's zilurgisertib showed reduced new bone lesion formation in fibrodysplasia ossificans progressiva (FOP), and the FDA has started Priority Review of the NDA with a decision date of Sept. 26, 2026. The update is supportive for both companies because it advances a rare-disease therapy toward potential approval. While the news is materially positive for the program, it is still a regulatory step rather than final approval.

Analysis

Mirum and Incyte's zilurgisertib showed reduced new bone lesion formation in fibrodysplasia ossificans progressiva (FOP), and the FDA has started Priority Review of the NDA with a decision date of Sept. 26, 2026. The update is supportive for both companies because it advances a rare-disease therapy toward potential approval. While the news is materially positive for the program, it is still a regulatory step rather than final approval.