Mirum Pharmaceuticals MIRM announced that it has completed enrollment in the phase III EXPAND study, which evaluated Livmarli (maralixibat) for treating cholestatic pruritus in patients aged six months and above with rare cholestatic liver diseases, including biliary atresia.
The primary endpoint of the EXPAND study is to see the change in pruritus severity from baseline to week 20, while secondary endpoints include changes in serum bile acids and other markers of cholestatic liver disease.
The double-blind, placebo-controlled phase III study is designed to support a potential label expansion of Livmarli into additional settings of cholestatic pruritus. Top-line data from the same is expected in the fourth quarter of 2026.
Livmarli, is an orally administered ileal bile acid transporter (“IBAT”) inhibitor currently approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe.
Last year, the FDA approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The oral tablet was launched in the United States in June 2025 and is likely to offer convenience for older patients.
MIRM's Price Performance
Year to date, shares of Mirum have rallied 17.3% compared with the industry’s rise of 2.8%.
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MIRM's Top-Line Aided by Livmarli Sales & Other Products
The majority of Mirum’s revenues is being driven by its lead product, Livmarli, which has been witnessing steady sales uptake since launch.
In 2025, Livmarli’s net product sales were $360 million, up 68.8% year over year. The continued demand for Livmarli is driving the top line, and the momentum is expected to continue as 2026 progresses. The drug remains a key top-line driver for the company.
Besides Livmarli, Mirum is also making good progress with its other marketed products — Cholbam capsules and Ctexli tablets, which are approved for certain rare diseases. These products were added to Mirum’s commercial portfolio following the acquisition of Travere Therapeutics’ TVTX bile acid products in 2023.
Revenues from these bile acid medicines were $161.3 million, up 31% year over year in 2025. The acquisition of TVTX’s bile acid products has diversified Mirum’s revenue stream.
Reflecting the strong sales of its marketed products, Mirum expects worldwide net product sales of approximately $630-$650 million in 2026.
MIRM's Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Phathom Pharmaceuticals PHAT and ANI Pharmaceuticals ANIP, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 24 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have plunged 37.1% in the year-to-date period.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.14 to $8.72, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 8.6% in the year-to-date period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report
Mirum Pharmaceuticals, Inc. (MIRM): Free Stock Analysis Report
Phathom Pharmaceuticals, Inc. (PHAT): Free Stock Analysis Report
Travere Therapeutics, Inc. (TVTX): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).