• Mirum Pharmaceuticals disclosed pivotal Phase 2 PROGRESS Cohort 1 results for oral ALK2 inhibitor zilurgisertib in FOP, already presented at ENDO 2026.
• The trial showed fewer new bone lesions and less overall disease progression on treatment versus placebo, with benefits sustained through 48 weeks.
• Patients who switched from placebo to zilurgisertib in the extension also showed no new lesions, supporting durability and crossover benefit.
• The FDA accepted an NDA for patients aged 12 and older with Priority Review, setting a PDUFA target action date of September 26, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mirum Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260614539468) on June 14, 2026, and is solely responsible for the information contained therein.