Mirum Finishes Participant Enrollment and Screening for Liver Disease Research

Mirum Pharmaceuticals Advances HDV Drug Trials

Mirum Pharmaceuticals (MIRM) has successfully finished enrolling participants in its phase III AZURE-1 clinical trial, which is assessing brelovitug as a treatment for chronic hepatitis delta virus (HDV). At the same time, the company has wrapped up the screening process for the phase III AZURE-4 study, also focused on brelovitug for HDV.

The company anticipates releasing initial 24-week results from both AZURE-1 and AZURE-4 in the latter half of 2026. These findings are expected to support Mirum’s planned submission of a biologics license application (BLA) for brelovitug in HDV to the FDA in 2027, potentially paving the way for a product launch.

Following this announcement, Mirum’s stock price dropped by 5.6% yesterday.

So far this year, Mirum shares have climbed 11.2%, outpacing the industry average gain of 8.1%.

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Update on Brelovitug’s Development for HDV

In January 2026, Mirum expanded its portfolio by acquiring Bluejay Therapeutics, a private biotech company. This acquisition brought brelovitug, a fully human monoclonal antibody targeting chronic HDV, into Mirum’s pipeline.

This strategic move strengthens Mirum’s presence in the field of severe liver diseases.

Brelovitug has already received Breakthrough Therapy designation from the FDA for treating chronic HDV infection.

HDV is known for being a particularly aggressive form of hepatitis with rapid progression and very few available therapies.

Both the AZURE-1 and AZURE-4 trials are measuring a combined endpoint of virologic response and ALT normalization at 24 weeks, aligning with FDA recommendations for accelerated approval of brelovitug in HDV.

Mirum’s Commercial Products and Revenue Growth

Mirum’s flagship product, Livmarli (maralixibat), is an oral IBAT inhibitor approved globally for managing cholestatic pruritus in patients with Alagille syndrome (ALGS). In the United States and Europe, it is also approved for certain cases of progressive familial intrahepatic cholestasis (PFIC).

The FDA has recently approved a new tablet version of Livmarli for use in both ALGS and PFIC patients experiencing cholestatic pruritus.

Livmarli generated $360 million in net sales in 2025, marking a 68.8% increase from the previous year and representing a significant portion of Mirum’s revenue.

Beyond Livmarli, Mirum has seen strong performance from Cholbam capsules and Ctexli tablets, which are approved for select rare diseases. Combined sales of these bile acid products rose 31% year over year to $161.3 million in 2025.

Mirum Pharmaceuticals, Inc. Stock Performance

Stock Ratings and Alternatives in Biotech

Mirum currently holds a Zacks Rank #3 (Hold).

Other biotech companies with higher Zacks rankings include:

• ANI Pharmaceuticals (ANIP)
• ALX Oncology Holdings (ALXO)
• Replimune Group (REPL)

All three carry a Zacks Rank #2 (Buy).

Recent Performance Highlights

• Over the past two months, ANI Pharmaceuticals’ projected 2026 earnings per share increased from $8.08 to $8.22, and 2027 estimates rose from $9.25 to $9.90. ANIP shares are down 4.2% year to date. The company exceeded earnings expectations in each of the last four quarters, with an average positive surprise of 22.21%.
• ALX Oncology’s estimated loss per share for 2026 improved from $1.21 to $0.88, and for 2027 from $0.99 to $0.60. ALXO shares have surged 88.5% year to date, though the company missed earnings estimates in all four recent quarters, with an average negative surprise of 12.82%.
• Replimune’s projected loss per share for 2026 narrowed from $3.59 to $3.41, and for 2027 from $2.42 to $2.33. REPL shares have dropped 27.6% so far this year. The company beat earnings estimates in one of the last four quarters, missing in the other three, with an average negative surprise of 4.46%.

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