Mirum Phase 3 EXPAND Study Meets Primary and All Five Secondary Endpoints
Mirum reported that its Phase 3 EXPAND study of LIVMARLI met the primary itch endpoint and all five secondary endpoints, with no new safety signals. The company plans to file a U.S. sNDA in H1 2027.
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12:28:57 PM UTC
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MIRM Mirum Pharmaceuticals: Phase 3 EXPAND Trial of LIVMARLI Meets Primary Endpoint; Shares Rise 6.1% Premarket ⠀ · LIVMARLI significantly improved cholestatic pruritus vs. placebo (p=0.0004) and reduced serum bile acids by 69% vs. placebo (p<0.0001). · Study also achieved statistical significance across all five prespecified secondary endpoints, including in patients with biliary atresia. · Mirum plans a U.S. sNDA submission in H1 2027; no new safety signals were observed.
Mirum said its Phase 3 EXPAND study of LIVMARLI achieved its primary itch endpoint and all five secondary endpoints, including analyses in biliary atresia. No new safety signals were reported. S. sNDA in H1 2027.