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Mirum's Brelovitug Meets Goal in Phase III AZURE-1 Study in HDV
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Key Takeaways
Mirum's brelovitug met the primary endpoint in the phase III AZURE-1 study in HDV.
56% patients on 300 mg weekly and 45% on 900 mg every four weeks met the combined endpoint.
Brelovitug's phase III AZURE-4 top-line data are expected in the fourth quarter of 2026.
Mirum Pharmaceuticals (MIRM - Free Report) announced that the phase III portion of the AZURE-1 study evaluating its pipeline candidate, brelovitug, for the treatment of patients with chronic hepatitis delta virus (HDV) has met its primary endpoint.
Data from the study showed that 56% of patients receiving brelovitug (300 mg) once weekly and 45% of patients receiving brelovitug (900 mg) once every four weeks achieved the combined endpoint of virologic response and alanine aminotransferase (ALT) normalization compared with 0% in the delayed-treatment arm at week 24.
The phase III portion of the AZURE-1 study enrolled treatment-naive patients who were randomized in a 2:2:1 ratio to receive brelovitug (300 mg) once weekly, brelovitug (900 mg) administered once every four weeks, or delayed treatment starting at week 24.
Treatment with brelovitug was generally safe and well tolerated across dose groups, with no new safety concerns observed.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
MIRM’s Price Performance
Year to date, shares of Mirum have rallied 11.3% compared with the industry’s rise of 8.3%.
Image Source: Zacks Investment Research
More on MRIM’s Latest Data on Brelovitug
Mirum also reported 48-week data from the phase IIb portion of the AZURE-1 study. Data from the same study showed deepening viral suppression and higher rates of ALT normalization with longer treatment with brelovitug.
The full results from the phase III AZURE-1 study will be presented at an upcoming medical conference.
Notably, the AZURE-1 study is one of two pivotal phase III studies intended to support the registration package for brelovitug in the United States.
The company is also evaluating brelovitug in the phase III AZURE-4 study for the same indication.
Top-line data from the phase III AZURE-4 study is expected to be announced in the fourth quarter of 2026. Data from these studies are expected to form the basis of Mirum’s planned biologics license application submission for brelovitug in HDV in the United States in the first half of 2027.
If approved, a potential commercial launch for brelovitug is expected in the fourth quarter of 2027.
Over the past 60 days, estimates for Regeneron’s 2026 earnings per share have risen from $46.55 to $53.11, while estimates for 2027 have increased from $54.83 to $59.89 during the same time. REGN’s shares have lost 2.2% year-to-date.
Regeneron’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.93%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents to earnings of 24 cents. Earnings estimates for 2027 have increased from 25 cents to 73 cents per share during the same time. PGEN’s shares have rallied 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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Mirum's Brelovitug Meets Goal in Phase III AZURE-1 Study in HDV
Key Takeaways
Mirum Pharmaceuticals (MIRM - Free Report) announced that the phase III portion of the AZURE-1 study evaluating its pipeline candidate, brelovitug, for the treatment of patients with chronic hepatitis delta virus (HDV) has met its primary endpoint.
Data from the study showed that 56% of patients receiving brelovitug (300 mg) once weekly and 45% of patients receiving brelovitug (900 mg) once every four weeks achieved the combined endpoint of virologic response and alanine aminotransferase (ALT) normalization compared with 0% in the delayed-treatment arm at week 24.
The phase III portion of the AZURE-1 study enrolled treatment-naive patients who were randomized in a 2:2:1 ratio to receive brelovitug (300 mg) once weekly, brelovitug (900 mg) administered once every four weeks, or delayed treatment starting at week 24.
Treatment with brelovitug was generally safe and well tolerated across dose groups, with no new safety concerns observed.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
MIRM’s Price Performance
Year to date, shares of Mirum have rallied 11.3% compared with the industry’s rise of 8.3%.
Image Source: Zacks Investment Research
More on MRIM’s Latest Data on Brelovitug
Mirum also reported 48-week data from the phase IIb portion of the AZURE-1 study. Data from the same study showed deepening viral suppression and higher rates of ALT normalization with longer treatment with brelovitug.
The full results from the phase III AZURE-1 study will be presented at an upcoming medical conference.
Notably, the AZURE-1 study is one of two pivotal phase III studies intended to support the registration package for brelovitug in the United States.
The company is also evaluating brelovitug in the phase III AZURE-4 study for the same indication.
Top-line data from the phase III AZURE-4 study is expected to be announced in the fourth quarter of 2026. Data from these studies are expected to form the basis of Mirum’s planned biologics license application submission for brelovitug in HDV in the United States in the first half of 2027.
If approved, a potential commercial launch for brelovitug is expected in the fourth quarter of 2027.
MIRM's Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Regeneron Pharmaceuticals (REGN - Free Report) and Precigen (PGEN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Regeneron’s 2026 earnings per share have risen from $46.55 to $53.11, while estimates for 2027 have increased from $54.83 to $59.89 during the same time. REGN’s shares have lost 2.2% year-to-date.
Regeneron’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.93%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents to earnings of 24 cents. Earnings estimates for 2027 have increased from 25 cents to 73 cents per share during the same time. PGEN’s shares have rallied 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.