Core Insights - Mirum Pharmaceuticals has completed enrollment in the phase III EXPAND study for Livmarli, targeting cholestatic pruritus in patients aged six months and older with rare cholestatic liver diseases, including biliary atresia [1][8] - The study aims to support potential label expansion for Livmarli, with top-line data expected in Q4 2026 [2][8] - Livmarli, an orally administered IBAT inhibitor, is currently approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with progressive familial intrahepatic cholestasis [3][4] Company Performance - Mirum's shares have increased by 17.3% year to date, outperforming the industry average rise of 2.8% [5] - Livmarli's net product sales reached $360 million in 2025, reflecting a 68.8% year-over-year increase, driving the company's revenue growth [9] - The acquisition of Travere Therapeutics' bile acid products has diversified Mirum's revenue stream, with revenues from these products totaling $161.3 million, up 31% year over year in 2025 [10] Future Outlook - Mirum anticipates worldwide net product sales of approximately $630-$650 million in 2026, driven by strong sales of Livmarli and other marketed products [11]

Group 1 - Mirum Pharmaceuticals received approval from Health Canada for the tablet formulation of Livmarli to treat cholestatic pruritus in patients with Alagille syndrome (ALGS) [1] - Following the approval announcement, Mirum's shares increased by over 5% in pre-market trading [1] - ALGS is a rare genetic disorder that can cause cholestasis and severe itching due to bile duct abnormalities [1] Group 2 - Livmarli was previously approved in Canada as an oral solution for ALGS patients aged 12 months and older [2] - Health Canada also authorized Livmarli for treating cholestatic pruritus in patients aged 12 months and older with progressive familial intrahepatic cholestasis (PFIC) [2] - Mirum Pharmaceuticals shares closed at $103.96 on Wednesday, reflecting a decrease of 1.41% [2]

Core Insights - GSK plc announced that the European Medicines Agency has accepted its marketing authorization application for linerixibat, an investigational IBAT inhibitor, aimed at treating cholestatic pruritus in patients with primary biliary cholangitis [1][7] - The MAA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in symptoms compared to placebo [4][7] - GSK aims for linerixibat to be the first approved therapy for itch associated with PBC, addressing a significant unmet medical need in the market [5][6] Company Developments - A regulatory filing for linerixibat is under review in the United States, with a final FDA decision expected on March 24, 2026 [2] - Year-to-date, GSK's shares have increased by 13.1%, contrasting with a 3.3% decline in the industry [2] Competitive Landscape - The PBC treatment market is seeing increased competition, with other companies like Gilead Sciences and Mirum Pharmaceuticals developing their own therapies [6][8][9] - Gilead's seladelpar received accelerated approval from the FDA and conditional marketing authorization from the European Commission for PBC treatment [8] - Mirum is currently evaluating volixibat in a phase IIb study, with enrollment expected to complete in 2026 [9]