Mirum Pharmaceuticals MIRM incurred a loss of 39 cents per share (excluding certain one-time expenses) in the first quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 40 cents. The company had reported a loss of 30 cents per share in the year-ago quarter.
Revenues in the first quarter totaled $159.9 million, up 43.3% year over year. The figure also beat the Zacks Consensus Estimate of $148 million. The top line was driven by strong growth of its marketed products, Livmarli (maralixibat) and recently acquired bile acid medicines, Cholbam and Ctexli (chenodiol).
Livmarli is 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, which is likely to offer convenience for older patients.
Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Ctexli tablets to its portfolio of commercialized drugs.
Shares of Mirum have rallied 39.3% so far this year against the industry’s decline of 1.6%.
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MIRM's Q1 Earnings in Detail
Livmarli’s net product sales were $113.8 million in the first quarter, reflecting an increase of 55% year over year. Livmarli sales in the United States were $84 million, reflecting strong demand across all indications. In ex-U.S. markets, Livmarli sales were $30 million.
Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $46.1 million in the first quarter, reflecting an increase of 20% year over year.
The company did not record any license and other revenues in the reported quarter.
Research and development expenses increased almost 138.8% year over year to $97.9 million.
Selling, general and administrative expenses totaled $96.3 million, up almost 66.9% from the year-ago quarter’s level.
As of March 31, 2026, Mirum had cash, cash equivalents and investments worth $420.6 million compared with $391.4 million as of Dec 31, 2025.
MIRM’s 2026 Guidance Raised
Reflecting the strong performance of its marketed products, Mirum raised its full-year revenue guidance for 2026.
The company now expects worldwide net product sales of approximately $660-$680 million in 2026, compared with the previous expectation of $630-$650 million.
MIRM's Key Pipeline Updates
Mirum is evaluating Livmarli in the phase III EXPAND study for treating additional rare cholestatic conditions. Enrollment in the study was completed last month, with top-line data from the same expected in the fourth quarter of 2026.
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).
The company recently announced that the phase IIb VISTAS study, which evaluated volixibat in patients with primary sclerosing cholangitis, has met its primary endpoint.
MIRM has scheduled a pre-new drug application (NDA) meeting with the FDA for volixibat in PSC in the summer of 2026 and plans to submit the NDA in the second half of 2026.
The company expects to report top-line data from the VANTAGE study in the first quarter of 2027.
Mirum is evaluating its newly in-licensed PDE4D inhibitor, MRM-3379, in the phase II BLOOM study, for treating Fragile X syndrome, a rare genetic neurocognitive disorder.
Mirum recently completed the acquisition of privately held biotech Bluejay Therapeutics. Through this deal, it added brelovitug — a fully human monoclonal antibody being developed to treat chronic hepatitis delta virus (“HDV”) — to its pipeline.
Top-line data from the phase III AZURE-1 and AZURE-4 studies evaluating brelovitug in HDV are expected in the second half of 2026.
Along with the earnings release, Mirum announced that it has in-licensed exclusive worldwide rights to zilurgisertib, a once-daily oral ALK2 inhibitor from Incyte INCY. The candidate is being developed for treating fibrodysplasia ossificans progressiva (FOP).
Based on data from the pivotal phase II PROGRESS study, which was conducted by Incyte, the FDA has accepted the NDA for zilurgisertib in FOP. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Sept. 26, 2026. If approved, MIRM expects to launch zilurgisertib by 2026-end.
As part of the exclusive worldwide licensing deal for zilurgisertib, INCY received an upfront payment of $16 million and is eligible for additional development and regulatory milestones.
Mirum Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Mirum Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Mirum Pharmaceuticals, Inc. Quote
MIRM's Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Agenus AGEN and AnaptysBio ANAB, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have surged 23.9% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Over the past 60 days, 2026 loss per share estimates for AnaptysBio have narrowed from $1.42 to $1.40, while estimates for 2027 have moved from a loss of $4.59 per share to earnings of $3.01 during the same time. ANAB stock has increased 38.9% year to date.
AnaptysBio’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 59.70%.
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This article originally published on Zacks Investment Research (zacks.com).