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Will Strong Livmarli Uptake Continue to Aid MIRM's Revenues in 2026?
ZACKS· 2025-12-18 16:46
Core Insights - Mirum Pharmaceuticals' revenue is primarily driven by its lead product, Livmarli, which has shown consistent sales growth since its launch [1][3][11] Product Overview - Livmarli is an orally administered IBAT inhibitor approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with PFIC in the U.S. and Europe [2] - A new tablet formulation of Livmarli has been approved, enhancing convenience for older patients [3] Financial Performance - In the first nine months of 2025, Livmarli's net product sales reached $253.6 million, reflecting a 70% year-over-year increase [3] - Mirum anticipates total revenues for 2025 to be between $500 million and $510 million, up from a previous estimate of $490 million to $510 million, driven by Livmarli and bile acid products [6] Product Portfolio Expansion - Mirum has made progress with other marketed products, Cholbam and Ctexli, which were added to its portfolio following the acquisition of Travere Therapeutics' bile acid products in 2023 [5][6] Pipeline Developments - Mirum's lead pipeline candidate, volixibat, is currently under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [7] Competitive Landscape - Mirum faces competition from Albireo AB's Bylvay, which directly competes with Livmarli in the PFIC and ALGS markets [9] - GSK is developing linerixibat, another IBAT inhibitor, which could pose significant competition for Mirum's pipeline candidate volixibat [10][12] Stock Performance and Valuation - Over the past six months, Mirum's shares have increased by 35.9%, outperforming the industry and the S&P 500 [13] - The company's shares are trading at a premium, with a price/book ratio of 11.87 compared to the industry average of 3.55 [14] Earnings Estimates - The Zacks Consensus Estimate for Mirum's 2025 loss per share has narrowed from 67 cents to 41 cents, while estimates for 2026 have shifted from earnings of 4 cents per share to a loss of 29 cents [15]
MIRM Enrolls First Patient in Phase II Fragile X Syndrome Study
ZACKS· 2025-12-02 16:16
Core Insights - Mirum Pharmaceuticals has initiated the phase II BLOOM study for MRM-3379, a PDE4D inhibitor aimed at treating Fragile X syndrome (FXS), with the first patient enrolled [1][6] - The study will focus on safety, tolerability, and potential clinical benefits, with top-line data expected in 2027 [2][6] - FXS affects approximately 50,000 males in the U.S. and Europe, and currently, there are no approved therapies for this condition [2] Company Developments - MRM-3379 has shown promise in improving cognitive and behavioral symptoms associated with FXS in preclinical studies, indicating a potential novel treatment approach [3] - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis, generating significant revenue [7][8] - Livmarli's net product sales reached $253.6 million in the first nine months of 2025, reflecting a 70% year-over-year increase [8] Pipeline Progress - Mirum is advancing other products, including Cholbam capsules and Ctexli tablets, which are also approved for rare diseases, contributing to revenue growth [9] - The lead pipeline candidate, volixibat, is undergoing evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data expected in 2026 [9][10] Market Performance - Year-to-date, Mirum's shares have increased by 69.3%, outperforming the industry average rise of 20.3% [4]