FDA approves Mirum/Incyte's Atebrioz for FOP; brelovitug meets AZURE-1 Phase 3 primary endpoint

Mirum Pharmaceuticals, Inc.

FDA approved Atebrioz (zilurgisertib) 100 mg once daily to reduce total new heterotopic ossification volume in FOP patients aged 12+; U.S. launch expected October 2026.
In PROGRESS Cohort 1, Week 24 mean new HO lesion volume fell 3.2 cm3 with zilurgisertib vs increase of 24.6 cm3 on placebo; effects maintained through Week 48.
Phase 3 AZURE-1: brelovitug met primary endpoint with 56% (300 mg QW) and 45% (900 mg Q4W) vs 0% delayed treatment (p<0.0001) in 153 treatment-naive chronic HDV patients.
Brelovitug BLA submission expected H1 2027 and U.S. launch Q4 2027; AZURE-4 topline due Q4 2026. Mirum estimates >$1B annual revenue potential for brelovitug and >$200M for Atebrioz.
Week 48 Phase 2b data showed deepening response: 300 mg QW primary endpoint rate rose from 45% to 55%, 900 mg Q4W from 35% to 55%; no new safety signals.

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