Mirum says LIVMARLI study met all EXPAND endpoints
Mirum said its Phase 3 EXPAND study of LIVMARLI met the primary and five secondary endpoints, with a U.S. sNDA planned for H1 2027.
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what happened
TradingView reported that Mirum Pharmaceuticals said its Phase 3 EXPAND study of LIVMARLI achieved the primary endpoint for itch and all five secondary endpoints. The analysis also covered biliary atresia, and the company reported no new safety signals.
The ItchRO difference was 0.98 points versus placebo, while sBA fell 70.1% compared with a 3.5% reduction for placebo. The primary endpoint was statistically significant at p=0.0004. Mirum plans to submit a supplemental new drug application, or sNDA, in the U.S. during H1 2027.
The information is based on Mirum Pharmaceuticals’ original press release distributed by BusinessWire. TradingView said LIVMARLI is being extended beyond ALGS and PFIC. The material is an AI-generated summary and may contain inaccuracies.
why it matters
The results reduce uncertainty around expanding LIVMARLI into additional ultra-rare cholestatic pruritus settings. The next regulatory milestones are the U.S. sNDA filing and acceptance, while the eventual label scope and payer access remain important market considerations.
instruments
sources
- Mirum Pharmaceuticals, Inc. (MIRM) Phase 3 EXPAND Meets Primary, All Secondary Endpoints — TradingView, 12 October 2026 at 12:00 UTC
prepared by the newsmetry newsroom with ai assistance from the sources listed below. not investment advice.
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