LIVMARLI Hits Primary Endpoint in Phase 3 EXPAND, sNDA Planned for H1 2027
MIRM sits 45% above its 52-week low of $63.232.
Summary
Mirum's LIVMARLI met the primary endpoint in the Phase 3 EXPAND study for cholestatic pruritus in ultra-rare liver diseases, with a placebo-adjusted 0.98-point improvement in itch severity (p=0.0004) and a 69% relative reduction in serum bile acids. All five secondary endpoints were also met, including the biliary atresia subgroup. Safety was consistent with prior experience, with no new signals. The company plans to submit an sNDA in H1 2027, expanding LIVMARLI's label beyond ALGS and PFIC. This follows recent positive Phase 3 data for brelovitug in HDV and FDA approval of Atebrioz for FOP, reinforcing Mirum's pipeline momentum.
Updates
· SEC 8-K — The 8-K provides detailed efficacy and safety tables, including 70.1% sBA reduction for maralixibat vs 3.5% placebo and 64% diarrhea rate.
At the time of this announcement, MIRM was trading at $92.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.6B. The 52-week trading range was $63.23 to $130.00. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.