- Mirum Pharmaceuticals recently reported past positive pivotal phase II results from the PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva and secured US FDA priority review acceptance for its new drug application, with a decision scheduled for late September 2026.
- This combination of encouraging data in an ultra-rare indication and accelerated regulatory review could meaningfully broaden Mirum’s rare disease portfolio beyond its existing commercial assets.
- We’ll now examine how the FDA’s priority review for zilurgisertib may reshape Mirum’s rare-disease investment narrative and future growth mix.
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