Watch for AZURE-4 topline results in Q4 2026, which is the second pivotal study for the brelovitug BLA. Also monitor EMA decision on zilurgisertib and early Atebrioz sales trajectory post-launch in October.
Price Chart
Executive Summary
Mirum Pharmaceuticals announced FDA approval of Atebrioz (zilurgisertib) for FOP and positive Phase 3 AZURE-1 data for brelovitug in chronic hepatitis delta. The FDA approval of Atebrioz adds a new revenue stream with estimated annual potential >$200M, while brelovitug met its primary endpoint with high statistical significance, supporting a BLA submission expected in H1 2027 and estimated peak revenue >$1B.
Key Facts
- FDA approved Atebrioz (zilurgisertib) for FOP in patients aged 12+ on September 25, 2026
- Atebrioz commercial launch expected in U.S. in October 2026
- Phase 3 AZURE-1 study of brelovitug met primary endpoint: 56% (300mg QW) and 45% (900mg Q4W) vs 0% placebo (p<0.0001) for virologic response + ALT normalization in HDV
- BLA submission for brelovitug expected H1 2027, potential U.S. launch Q4 2027
- Company estimates >$1B annual revenue potential for brelovitug in HDV and >$200M for Atebrioz in FOP
- EU marketing authorization application for zilurgisertib under review by EMA
- Topline results from Phase 3 AZURE-4 study expected Q4 2026
Financial Impact
Company estimates >$1B annual revenue potential for brelovitug in HDV and >$200M for Atebrioz in FOP
Risk Factors
- Brelovitug requires successful AZURE-4 data and BLA approval; regulatory risk remains
- Atebrioz commercial launch execution and market access risks
- Competition in HDV treatment landscape
- Dependence on Incyte for zilurgisertib development and commercialization
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001759425-26-000049 |
| Document: 0001759425-26-000049-index-headers.html | 0001759425-26-000049 |
| Document: 0001759425-26-000049-index.html | 0001759425-26-000049 |
| Document: 0001759425-26-000049.txt | 0001759425-26-000049 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | $83.27 | awaiting T+60 | — | $83.27 (−0.00%) |
Oct 13, 2026 13d ago | 8-K | $79.62 | awaiting T+60 | — | $83.27 (+4.58%) |
Sep 28, 2026 28d ago | 8-K | $87.96 | awaiting T+60 | — | $83.27 (−5.33%) |
Aug 19, 2026 9w ago | Insider Cluster | $97.18 | awaiting T+60 | — | $83.27 (−14.31%) |
Aug 12, 2026 10w ago | Insider Cluster | $98.77 | awaiting T+60 | — | $83.27 (−15.69%) |
Aug 11, 2026 10w ago | Insider Cluster | $98.97 | awaiting T+60 | — | $83.27 (+15.86%) |
Aug 10, 2026 11w ago | 144 | $98.23 | awaiting T+60 | — | $83.27 (−15.23%) |
Aug 5, 2026 11w ago | 8-K | $94.12 | awaiting T+60 | — | $83.27 (−11.52%) |
Jul 8, 2026 15w ago | Insider Cluster | $127.70 $82.93 | ▼ −35.06% | ▼ −37.44% | $83.27 (−34.79%) |
Jun 11, 2026 19w ago | Institutional Cluster | $99.54 $100.90 | ▲ +1.37% | ▼ −3.03% | $83.27 (−16.35%) |
US Market Status
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