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Mirum Completes Enrollment & Screening in Liver Disease Studies
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Key Takeaways
MIRM finished enrollment in phase III AZURE-1 and screening in AZURE-4, evaluating brelovitug in chronic HDV.
Mirum expects 24-week top-line data from both AZURE-1 and AZURE-4 studies in H2 2026.
MIRM plans a potential BLA filing for brelovitug in HDV and subsequent U.S. launch in 2027.
Mirum Pharmaceuticals (MIRM - Free Report) announced that it has completed enrollment in the phase III AZURE-1 study, evaluating its pipeline candidate, brelovitug, for the treatment of chronic hepatitis delta virus (HDV). Simultaneously, the company completed screening in the phase III AZURE-4 study, which is evaluating brelovitug for the same indication.
The company expects to report top-line 24-week data from the phase III AZURE-1 and AZURE-4 studies in the second half of 2026. Data from these studies are expected to form the basis of Mirum’s planned biologics license application (BLA) submission for brelovitug in HDV in the United States in 2027, along with a potential launch.
Shares of Mirum were down 5.6% yesterday following the announcement of the news.
In the year-to-date period, the stock has risen 11.2% compared with the industry’s increase of 8.1%.
Image Source: Zacks Investment Research
More on MIRM’s Brelovitug Program in HDV
In January 2026, Mirum 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 HDV — to its pipeline.
The deal will help Mirum expand its footprint in severe liver diseases.
The FDA has already granted Breakthrough Therapy designation to brelovitug for the treatment of chronic HDV infection.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
Notably, both the AZURE-1 and AZURE-4 studies are evaluating a composite endpoint of virologic response and ALT normalization at 24 weeks, in line with the FDA’s guidance for accelerated approval of brelovitug in HDV.
MIRM’s Marketed Drugs Aid Revenues
Mirum’s 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 (“ALGS”) worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis (“PFIC”) in the United States and Europe.
The FDA has also approved a new tablet formulation of Livmarli for treating cholestatic pruritus in patients with ALGS and PFIC.
In 2025, Livmarli’s net product sales were $360 million, up 68.8% year over year. The drug has been driving the majority of the company’s revenues.
In addition to Livmarli, Mirum is also making good progress with Cholbam capsules and Ctexli tablets, which are approved for certain rare diseases. Sales of the bile acid products increased 31% year over year to $161.3 million in 2025.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.08 to $8.22, while the same for 2027 have increased from $9.25 to $9.90. ANIP’s shares have fallen 4.2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, ALX Oncology’s 2026 loss per share estimates have narrowed from $1.21 to 88 cents, while the same for 2027 have narrowed from 99 cents to 60 cents. ALXO shares have rallied 88.5% year to date.
ALX Oncology’s earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.
Over the past 60 days, Replimune’s 2026 loss per share estimates have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have plunged 27.6% year to date.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.
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Mirum Completes Enrollment & Screening in Liver Disease Studies
Key Takeaways
Mirum Pharmaceuticals (MIRM - Free Report) announced that it has completed enrollment in the phase III AZURE-1 study, evaluating its pipeline candidate, brelovitug, for the treatment of chronic hepatitis delta virus (HDV). Simultaneously, the company completed screening in the phase III AZURE-4 study, which is evaluating brelovitug for the same indication.
The company expects to report top-line 24-week data from the phase III AZURE-1 and AZURE-4 studies in the second half of 2026. Data from these studies are expected to form the basis of Mirum’s planned biologics license application (BLA) submission for brelovitug in HDV in the United States in 2027, along with a potential launch.
Shares of Mirum were down 5.6% yesterday following the announcement of the news.
In the year-to-date period, the stock has risen 11.2% compared with the industry’s increase of 8.1%.
Image Source: Zacks Investment Research
More on MIRM’s Brelovitug Program in HDV
In January 2026, Mirum 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 HDV — to its pipeline.
The deal will help Mirum expand its footprint in severe liver diseases.
The FDA has already granted Breakthrough Therapy designation to brelovitug for the treatment of chronic HDV infection.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
Notably, both the AZURE-1 and AZURE-4 studies are evaluating a composite endpoint of virologic response and ALT normalization at 24 weeks, in line with the FDA’s guidance for accelerated approval of brelovitug in HDV.
MIRM’s Marketed Drugs Aid Revenues
Mirum’s 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 (“ALGS”) worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis (“PFIC”) in the United States and Europe.
The FDA has also approved a new tablet formulation of Livmarli for treating cholestatic pruritus in patients with ALGS and PFIC.
In 2025, Livmarli’s net product sales were $360 million, up 68.8% year over year. The drug has been driving the majority of the company’s revenues.
In addition to Livmarli, Mirum is also making good progress with Cholbam capsules and Ctexli tablets, which are approved for certain rare diseases. Sales of the bile acid products increased 31% year over year to $161.3 million in 2025.
Mirum Pharmaceuticals, Inc. Price
Mirum Pharmaceuticals, Inc. price | 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 ANI Pharmaceuticals (ANIP - Free Report) , ALX Oncology Holdings (ALXO - Free Report) and Replimune Group (REPL - Free Report) , each 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 ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.08 to $8.22, while the same for 2027 have increased from $9.25 to $9.90. ANIP’s shares have fallen 4.2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, ALX Oncology’s 2026 loss per share estimates have narrowed from $1.21 to 88 cents, while the same for 2027 have narrowed from 99 cents to 60 cents. ALXO shares have rallied 88.5% year to date.
ALX Oncology’s earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.
Over the past 60 days, Replimune’s 2026 loss per share estimates have narrowed from $3.59 to $3.41, while the same for 2027 have narrowed from $2.42 to $2.33. REPL’s shares have plunged 27.6% year to date.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.