Position for potential upside ahead of Phase 3 topline data in H2 2026; monitor for signs of commercial preparation and regulatory engagement. The strong efficacy and safety profile support brelovitug as a best-in-class candidate in HDV, a space with high unmet need.
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Executive Summary
Mirum Pharmaceuticals announced positive Phase 2b results for brelovitug in treating chronic hepatitis delta virus (HDV), with 100% and 75% virologic response rates in the two dose groups versus 0% in the control. The drug was well tolerated, supporting its potential as a single-agent therapy and advancing the program toward Phase 3 topline data in H2 2026.
Key Facts
- Brelovitug met primary endpoint in Phase 2b AZURE-1 study for chronic HDV treatment
- 100% of patients in 300 mg QW arm and 75% in 900 mg Q4W arm achieved virologic response vs. 0% in delayed treatment arm
- Primary composite endpoint (virologic response + ALT normalization) achieved in 45% and 35% of patients, respectively
- Treatment was well tolerated with no grade 3+ treatment-related adverse events and no discontinuations due to AEs
- Full results to be presented at EASL Congress in May 2026; Phase 3 topline data expected in H2 2026, with potential BLA submission and U.S. launch in 2027
Financial Impact
Significant positive impact on valuation potential; drug advancement reduces development risk for a high-unmet-need indication with no approved therapies
Risk Factors
- Phase 3 results may not replicate Phase 2b efficacy
- Regulatory requirements may exceed current expectations
- Competition could emerge before 2027 launch
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-179048 |
| Document: 0001193125-26-179048-index-headers.html | 0001193125-26-179048 |
| Document: 0001193125-26-179048-index.html | 0001193125-26-179048 |
| Document: 0001193125-26-179048.txt | 0001193125-26-179048 |
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| Type | Now | ||||
|---|---|---|---|---|---|
Aug 19, 2026 6w ago | Insider Cluster | $102.24 $98.82 | ▼ −3.35% | ▼ −1.39% | $82.58 (−19.23%) |
Aug 12, 2026 7w ago | Insider Cluster | $98.97 $100.61 | ▲ +1.66% | ▲ +3.55% | $82.58 (−16.56%) |
Aug 11, 2026 7w ago | Insider Cluster | $98.97 $100.61 | ▼ −1.66% | ▼ −3.55% | $82.58 (+16.56%) |
Aug 10, 2026 7w ago | 144 | $98.23 $98.30 | ▲ +0.07% | ▲ +1.13% | $82.58 (−15.93%) |
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Jun 11, 2026 16w ago | Institutional Cluster | $99.54 $127.70 | ▲ +28.29% | ▲ +26.40% | $82.58 (−17.04%) |
Jun 10, 2026 16w ago | Insider Cluster | $94.00 $127.70 | ▲ +35.85% | ▲ +32.23% | $82.58 (−12.15%) |
Jun 2, 2026 17w ago | Insider Cluster | $91.84 $125.59 | ▲ +36.76% | ▲ +37.76% | $82.58 (−10.08%) |
Jun 1, 2026 17w ago | 144 | $92.17 $120.46 | ▲ +30.69% | ▲ +32.26% | $82.58 (−10.40%) |
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