brelovitug — Topline data
Q4 2026
Topline results from the Phase 3 AZURE-4 study, the second of the two pivotal studies supporting the U.S. registration package, are expected in the fourth quarter of 2026.Source filing
MIRM biotech catalysts & pipeline
MIRUM PHARMACEUTICALS INC · Data as of 2026-10-25
Upcoming catalysts
brelovitug — NDA/BLA submission
H1 2027
The Company expects to submit a Biologics License Application ("BLA") to the FDA in the first half of 2027, with potential commercial launch in the U.S. in the fourth quarte r of 2027.Source filing
LIVMARLI (maralixibat) — Topline data
H1 2027
• LIVMARLI EXPAND Phase 3 study for pruritus in rare cholestatic conditions expected to complete enrollment in 2026; topline data expected in the first half of 2027.Source filing
LIVMARLI (maralixibat) — NDA/BLA submission
H1 2027
The Company plans to submit a supplemental New Drug Application in the United States in the first half of 2027 based on the Phase 3 EXPAND study results.Source filing
MRM-3379 — Topline data
in 2027
We are currently enrolling patients in the BLOOM Phase 2 clinical study of MRM-3379 in Fragile-X Syndrome ("FXS") and expect topline data in 2027.Source filing
volixibat — Topline data
Q1 2027
Completed enrollment in the volixibat VANTAGE Phase 2b study in cholestatic pruritus due to primary biliary cholangitis (PBC); topline results expected in Q1 2027.Source filing
volixibat — NDA/BLA submission
H1 2027
Pre-NDA meeting held for volixibat in cholestatic pruritus due to PSC; additional discussions planned before potential NDA submission, now targeted in H1 2027Source filing
brelovitug — Topline data
H2 2027
Topline results from the Phase 3 AZURE-2 and AZURE-3 studies are expected in the second half of 2027.Source filing
brelovitug — Regulatory decision
H2 2027
We believe that the results from the AZURE-1 and AZURE-4 trials may support a potential biologics license application ("BLA") submission to the FDA for brelovitug in HDV in the first half of 2027 followed by a potential approval and subsequent commercial launch, if approved, in the second half of 2027 in the U.S.Source filing