MIRM News & Events

Mirum Pharmaceuticals announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase 3 AZURE-4 study, both evaluating brelovitug for the treatment of chronic hepatitis delta virus. Achievement of these milestones confirms the expected timing of topline 24-week data in the second half of 2026. AZURE-1 and AZURE-4 together will form the basis of Mirum's U.S. BLA submission for brelovitug, which has received Breakthrough Therapy designation from the FDA for the treatment of chronic HDV infection. Topline data from AZURE-1 and AZURE-4 are expected in 2H 2026, with a potential BLA submission and launch in the U.S. in 2027.

Reports Q4 net loss ($5.73M) vs. ($23.79M) last year. "2025 was a year of meaningful progress and execution for Mirum, setting the stage for a pivotal 2026," said Chris Peetz, CEO of Mirum. "With the recent addition of brelovitug in HDV, we now expect four potentially registrational readouts over the next 18 months, beginning with topline results from the VISTAS study in PSC in the second quarter. This catalyst-rich period, combined with continued commercial performance and financial discipline, positions us well to deliver for shareholders and patients."

Mirum Pharmaceuticals is down -16.5%, or -$17.93 to $90.69.