Mirum (MIRM) Gets EC Approval for Livmarli Label Expansion

Core Opinion - The European Commission has approved Livmarli for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and older, which is expected to drive sales growth for Mirum Pharmaceuticals [9][13]. Company Developments - Mirum Pharmaceuticals has submitted an additional supplemental new drug application to the FDA for a higher concentration formulation of Livmarli, aiming to include younger patients with PFIC in the treatment [2]. - Livmarli generated sales of $42.8 million in the first quarter of 2024, reflecting a year-over-year increase of nearly 47% [11]. - The FDA previously approved Livmarli for cholestatic pruritus in patients aged five years and older with PFIC in March [10]. Clinical Data - Data from the phase III MARCH study indicated that Livmarli significantly reduced pruritus and serum bile acids compared to placebo, and improved total bilirubin and growth [5][16]. Market Performance - Shares of Mirum Pharmaceuticals increased by 4.3% following the European Commission's approval announcement [13]. - Year-to-date, Mirum's shares have rallied 21.6%, contrasting with a 7.1% decline in the industry [15]. Competitor Analysis - Other healthcare stocks with favorable rankings include Acrivon Therapeutics, Anavex Life Sciences, and RAPT Therapeutics, with varying degrees of performance and loss per share estimates [3][4][8][12].