MIRUM PHARMACEUTICALS INC · Data as of 2026-09-08
summer 2026
The Company has a pre-New Drug Application ("NDA") meeting for volixibat in PSC scheduled with the U.S. Food and Drug Administration ("FDA") in summer 2026, with a planned NDA submission in the second half of 2026.Source filing
Q3
Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.Source filing
H2 2026
Reported volixibat VISTAS Phase 2b study in primary sclerosing cholangitis (PSC) met primary endpoint; full results to be presented in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress on May 30 at 2:15 p.m. CEST; U.S. NDA submission expected in H2 2026.Source filing
Sep 26
The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.Source filing
Q4 2026
Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.Source filing
Q4 2026
LIVMARLI EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026.Source filing
H1 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
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
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
H1 2027
Based on these topline results, we expect to submit a New Drug Application ("NDA") to the FDA for volixibat for the treatment cholestatic pruritus in PSC in the second half of 2026, with both potential approval and subsequent launch of volixibat for the treatment of cholestatic pruritus in PSC, if approved, to occur in the first half of 2027.Source filing
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
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
H1 2028
Brelovitug is currently being evaluated in the global AZURE clinical program with topline results from the AZURE-1 and AZURE-4 registration-enabling clinical trials expected in the third and fourth quarter of 2026, respectively, and top-line results from the AZURE-2 and AZURE-3 registration-enabling clinical trials expected by the first half of 2028.Source filing