Mirum Pharmaceuticals Raises Sales Guidance on Strong LIVMARLI Growth
Event summary
- Mirum Pharmaceuticals raised full-year net product sales guidance to $680M–$700M, up from prior expectations.
- LIVMARLI® sales grew 46% YoY in Q2 2026, reaching $128.7M.
- FDA recommended a Phase 3 study for volixibat before NDA submission, delaying potential approval to H1 2027.
- Zilurgisertib’s PDUFA date set for September 26, 2026, with FDA Priority Review status.
The big picture
Mirum Pharmaceuticals is capitalizing on strong commercial momentum for LIVMARLI, but faces regulatory uncertainty with volixibat. The company’s ability to sustain growth hinges on successful execution across its pipeline while managing increased R&D expenses. With a robust cash position and strategic licensing deals, Mirum remains positioned in the competitive rare disease space.
What we're watching
- Regulatory Hurdles
- Whether Mirum can navigate FDA’s Phase 3 recommendation for volixibat without significant delays.
- Commercial Execution
- The pace at which LIVMARLI sales growth will sustain amid rising competition in rare disease therapies.
- Pipeline Milestones
- How topline results from brelovitug and zilurgisertib studies impact Mirum’s long-term pipeline strategy.
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