Brelovitug Hits Phase 3 Primary Endpoint in HDV, Paving Path to BLA
MIRM sits 45% above its 52-week low of $63.232.
Summary
Mirum's brelovitug met the primary endpoint in the Phase 3 AZURE-1 study for chronic hepatitis delta virus (HDV), with 56% of patients on the 300mg weekly dose and 45% on the 900mg monthly dose achieving combined virologic response and ALT normalization at Week 24, versus 0% in the delayed treatment arm (p<0.0001). The 48-week Phase 2b data showed deepening viral suppression, with 80% of patients on the 300mg dose achieving HDV RNA below the lower limit of quantification, up from 45% at Week 24, and 55% of patients in both dose arms achieved the combined endpoint. Safety was clean with no Grade 3+ adverse events in the treatment arms. This is the first of two pivotal studies needed for U.S. registration; topline results from the second study, AZURE-4, are expected in Q4 2026, with a BLA submission planned for H1 2027 and potential U.S. launch in Q4 2027. The company will host a conference call at 8:30 a.m. ET today to discuss the results. This follows the FDA approval of Atebrioz for FOP just three days ago, adding to a strong clinical momentum for Mirum's rare disease pipeline. Mirum estimates brelovitug annual revenue potential over $1 billion and Atebrioz over $200 million.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The 8-K adds Phase 2b 48-week data: 55% of patients in both dose arms achieved the combined endpoint, and 80% on 300mg had HDV RNA below LLOQ. Mirum estimates brelovitug annual revenue potential over $1 billion and Atebrioz over $200 million.
At the time of this announcement, MIRM was trading at $91.99 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.8B. The 52-week trading range was $63.23 to $130.00. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.