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MIRM's Brelovitug Scores Second Phase III Win, Nears BLA Filing in HDV
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Key Takeaways
Mirum's brelovitug meets the primary endpoint in its second successful Phase III HDV study.
Brelovitug achieved response rates of 59% and 44% across two dosing regimens versus 0% for delayed treatment.
Two studies to support a U.S. BLA filing for brelovitug in the first half of 2027, with launch eyed for Q4.
Mirum Pharmaceuticals (MIRM - Free Report) announced positive top-line results from the phase III AZURE-4 study evaluating brelovitug, an investigational treatment for chronic hepatitis delta virus (HDV) infection. The study met its primary endpoint, marking the second successful phase III study for brelovitug in chronic HDV and strengthening its prospects for potential FDA approval.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
Year to date, shares of Mirum have rallied 19.6% compared with the industry's increase of 12.3%.
Image Source: Zacks Investment Research
More on MIRM’s AZURE-4 Study Data
In the AZURE-4 study, 59% of patients receiving brelovitug 300 mg once weekly achieved the primary endpoint at week 24, which measured a combined virologic response and normalization of alanine aminotransferase (ALT) levels. The corresponding rate was 44% for patients receiving the brelovitug 900 mg dose every four weeks, compared with 0% in the delayed-treatment arm.
Brelovitug was generally well tolerated in AZURE-4, with no new safety signals reported.
The latest findings follow the positive data from the phase III AZURE-1 study announced in September, in which brelovitug also met its primary endpoint. Together, the two pivotal 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 Long-Term Data Add to Brelovitug's Prospects
Mirum also highlighted long-term data from phase II studies on brelovitug presented at the American Association for the Study of Liver Diseases (AASLD) meeting. Notably, brelovitug achieved 100% virologic response and 100% ALT normalization among patients with cirrhosis following up to 108 weeks of treatment.
The long-term findings also demonstrated deepening viral suppression, improved ALT normalization rates and reductions in liver stiffness with continued treatment with brelovitug. These results are encouraging given the risk of disease progression among patients with chronic HDV, particularly those with advanced liver disease.
Brelovitug represents a potential growth opportunity for Mirum as the company seeks to expand its rare disease portfolio. The treatment could address a significant unmet medical need, as there are currently no approved HDV treatments in most countries worldwide.
Over the past 30 days, estimates for Vericel’s 2026 earnings per share have risen from 54 cents to 73 cents, while estimates for 2027 have increased from 84 cents to 96 cents during the same time. VCEL shares have surged 63.9% year to date.
Vericel’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with the average surprise being 367.50%.
Over the past 30 days, estimates for Amneal’s 2026 earnings per share have risen from $1.03 to $1.04, while estimates for 2027 have increased from $1.16 to $1.19 during the same time. AMRX shares have rallied 69.7% year to date.
Amneal’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.21%.
Over the past 30 days, estimates for Collegium Pharmaceutical’s 2026 earnings per share have risen from $7.15 to $7.39, while estimates for 2027 have increased from $5.75 to $6.84 during the same time. COLL shares have plunged 47.2% year to date.
Collegium Pharmaceutical’s earnings beat estimates in three of the trailing four quarters, while missing estimates on the remaining occasion, with the average surprise being 10.53%.
View the Zacks #1 Rank List
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MIRM's Brelovitug Scores Second Phase III Win, Nears BLA Filing in HDV
Key Takeaways
Mirum Pharmaceuticals (MIRM - Free Report) announced positive top-line results from the phase III AZURE-4 study evaluating brelovitug, an investigational treatment for chronic hepatitis delta virus (HDV) infection. The study met its primary endpoint, marking the second successful phase III study for brelovitug in chronic HDV and strengthening its prospects for potential FDA approval.
HDV represents a highly aggressive form of viral hepatitis that progresses quickly, with very limited treatment options available.
Year to date, shares of Mirum have rallied 19.6% compared with the industry's increase of 12.3%.
Image Source: Zacks Investment Research
More on MIRM’s AZURE-4 Study Data
In the AZURE-4 study, 59% of patients receiving brelovitug 300 mg once weekly achieved the primary endpoint at week 24, which measured a combined virologic response and normalization of alanine aminotransferase (ALT) levels. The corresponding rate was 44% for patients receiving the brelovitug 900 mg dose every four weeks, compared with 0% in the delayed-treatment arm.
Brelovitug was generally well tolerated in AZURE-4, with no new safety signals reported.
The latest findings follow the positive data from the phase III AZURE-1 study announced in September, in which brelovitug also met its primary endpoint. Together, the two pivotal 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 Long-Term Data Add to Brelovitug's Prospects
Mirum also highlighted long-term data from phase II studies on brelovitug presented at the American Association for the Study of Liver Diseases (AASLD) meeting. Notably, brelovitug achieved 100% virologic response and 100% ALT normalization among patients with cirrhosis following up to 108 weeks of treatment.
The long-term findings also demonstrated deepening viral suppression, improved ALT normalization rates and reductions in liver stiffness with continued treatment with brelovitug. These results are encouraging given the risk of disease progression among patients with chronic HDV, particularly those with advanced liver disease.
Brelovitug represents a potential growth opportunity for Mirum as the company seeks to expand its rare disease portfolio. The treatment could address a significant unmet medical need, as there are currently no approved HDV treatments in most countries worldwide.
MIRM’s Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the drug/biotech sector are Vericel (VCEL - Free Report) , Amneal Pharmaceuticals (AMRX - Free Report) and Collegium Pharmaceutical (COLL - Free Report) , 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 30 days, estimates for Vericel’s 2026 earnings per share have risen from 54 cents to 73 cents, while estimates for 2027 have increased from 84 cents to 96 cents during the same time. VCEL shares have surged 63.9% year to date.
Vericel’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with the average surprise being 367.50%.
Over the past 30 days, estimates for Amneal’s 2026 earnings per share have risen from $1.03 to $1.04, while estimates for 2027 have increased from $1.16 to $1.19 during the same time. AMRX shares have rallied 69.7% year to date.
Amneal’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.21%.
Over the past 30 days, estimates for Collegium Pharmaceutical’s 2026 earnings per share have risen from $7.15 to $7.39, while estimates for 2027 have increased from $5.75 to $6.84 during the same time. COLL shares have plunged 47.2% year to date.
Collegium Pharmaceutical’s earnings beat estimates in three of the trailing four quarters, while missing estimates on the remaining occasion, with the average surprise being 10.53%.