Core Viewpoint - Mirum Pharmaceuticals is positioned for significant growth, with its share price having more than doubled in the past year and expectations for further increases in 2026 due to key developments in its pipeline and financial performance [1]. Financial Performance - Mirum achieved positive cash flow from operations in 2025, marking a significant milestone for the company [2]. - Net product sales for Livmarli increased by 69% year over year in 2025, reaching $359 million, while sales for Cholbam and Ctexli rose by 31% to $161 million. The company anticipates overall revenue guidance of $630 million to $650 million for the current year [5]. Regulatory Approvals - The company received two FDA approvals in the previous year: Ctexli for treating cerebrotendinous xanthomatosis and a tablet formulation of Livmarli for cholestatic pruritus in patients with Alagille syndrome and Progressive Familial Intrahepatic Cholestasis [3]. Pipeline Developments - On January 26, 2026, Mirum completed the acquisition of Bluejay Therapeutics, adding brelovitug to its pipeline, which targets chronic hepatitis delta virus, a rare liver disease with no current approved treatment in the U.S. [4]. - The company is expecting results from a Phase 2B clinical study of volixibat for primary sclerosing cholangitis in the second quarter of 2026, with plans to file for accelerated approval in the second half of the year [6]. - Results from a Phase 3 study of brelovitug for HDV treatment are anticipated in the latter half of 2026, with potential filing for approval in early 2027 if results are positive [8]. - The timing of the Phase 3 study of Livmarli for pruritus in rare cholestatic conditions has been accelerated, with enrollment expected to complete in the first half of 2026 and topline data to be reported by year-end [9].
Is Mirum Pharmaceuticals About to Soar in 2026?