Mirum Pharmaceuticals Boosts Revenue Guidance on Strong Rare Disease Drug Sales
Event summary
- Mirum Pharmaceuticals raised full-year revenue guidance to $660–$680 million, up from prior estimates, driven by 55% year-over-year growth in LIVMARLI sales.
- The company in-licensed zilurgisertib, an ALK2 inhibitor for fibrodysplasia ossificans progressiva (FOP), from Incyte, with a potential FDA approval date of September 26, 2026.
- Positive Phase 2b results for volixibat in primary sclerosing cholangitis (PSC) and brelovitug in chronic hepatitis delta virus (HDV) were reported, with NDA submissions expected in H2 2026.
- Mirum completed enrollment in key Phase 3 studies for brelovitug and LIVMARLI, with topline results anticipated in H2 2026 and Q4 2026, respectively.
The big picture
Mirum Pharmaceuticals is capitalizing on strong commercial momentum in rare disease therapies, particularly with LIVMARLI, while expanding its pipeline through strategic in-licensing deals. The company’s ability to secure regulatory approvals and deliver on clinical milestones will be critical in maintaining its leadership position in this niche but growing market segment. With a robust balance sheet and a focus on disciplined execution, Mirum is positioning itself for potential product launches and revenue growth in 2026.
What we're watching
- Regulatory Approval
- Whether the FDA will approve zilurgisertib for FOP by the September 26, 2026 PDUFA date, which would add a new product to Mirum’s portfolio.
- Commercial Execution
- How Mirum sustains its 55% year-over-year growth in LIVMARLI sales amid increasing competition in the rare disease space.
- Pipeline Progress
- The pace at which Mirum advances its Phase 3 studies for brelovitug and LIVMARLI, with topline results expected in H2 2026 and Q4 2026, respectively.
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