Mirum Pharmaceuticals’ (MIRM – Free Report) lead product, Livmarli (maralixibat), an orally administered ileal bile acid transporter (“IBAT”) inhibitor, is approved for the treatment of 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.
Sales of Livmarli have been rising steadily since its approval and launch worldwide. In 2024, Livmarli generated sales worth $213.3 million, reflecting an increase of 50.4% on a year-over-year basis. Though Livmarli is witnessing continued demand and driving the top line, the company’s high dependence on the drug remains a concern.
In the past year, shares of Mirum have surged 83.2% against the industry’s decline of 8.5%.
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More on MIRM’s Livmarli & Other Products
Mirum is evaluating Livmarli in the phase III EXPAND study for treating pruritus in rare cholestatic conditions. Enrollment in the study is expected to be completed in 2026.
Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and chenodiol tablets to its portfolio of commercialized drugs.
Cholbam is approved for treating bile acid synthesis disorders (“BASD”) and Zellweger spectrum disorders (“ZSD”).
In February 2025, the FDA approved Ctexli (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (“CTX”). Following the nod, Ctexli became the first and only treatment to be approved for this rare, progressive and debilitating disease.
Though revenues from bile acid products are adding to Mirum’s top-line growth, it remains to be seen whether Cholbam and Ctexli can reduce the heavy dependence on Livmarli for revenues in future quarters.
MIRM’s Other Pipeline Updates
Mirum’s lead pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).
Enrollment in the VISTAS study is expected to be completed in the second half of 2025, with top-line data expected to be announced in 2026. The company anticipates completing enrollment in the VANTAGE study by 2026.
Mirum also plans to initiate a phase II study on its recently in-licensed PDE4D inhibitor, MRM-3379, for treating Fragile X syndrome later in 2025.
MIRM’s Overdependence on Livmarli for Growth a Woe
Mirum’s heavy dependence on Livmarli for revenues remains a woe. Any regulatory setback for the drug could hurt the stock. Also, failure to generate sufficient revenues from the sale of Livmarli will hurt the stock in future quarters.
Pipeline setbacks are also an area of concern. In December 2023, Mirum announced disappointing top-line data from the phase IIb EMBARK study, which evaluated Livmarli in patients with biliary atresia (BA), who have undergone a Kasai surgery. The study did not meet its primary endpoint of mean change in bilirubin from baseline to week 26 or the key secondary endpoints. Subsequently, Mirum discontinued the BA clinical study. Similar setbacks in the future will impede the company’s growth prospects.
MIRM’s Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. (GILD – Free Report) , Dynavax Technologies Corporation (DVAX – Free Report) and Arvinas Inc (ARVN – Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.76 to $8.27. In the past year, shares of GILD have rallied 45.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s 2025 earnings per share have increased from 32 cents to 33 cents. During the same time, estimates for 2026 have increased from 49 cents to 57 cents. In the past year, shares of DVAX have rallied 10.8%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.49 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.19 to $3.65. In the past year, shares of ARVN have plunged 78.5%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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