MIRM SEC Filings, Earnings & Splits

Mirum Pharmaceuticals announced that its Phase 3 AZURE-4 study of brelovitug met its primary endpoint in chronic hepatitis delta virus, with 59% and 44% of patients in the 300 mg QW and 900 mg Q4W arms achieving the combined virologic response and ALT normalization endpoint versus 0% in the delayed-treatment arm. The company plans to submit a BLA to the FDA in the first half of 2027 with a potential U.S. launch in Q4 2027.

Mirum Pharmaceuticals issued a press release providing a corporate update and announcing its financial results for the quarter ended September 30, 2026.

Mirum Pharmaceuticals entered into a transition and separation agreement with Joanne Quan, providing for her employment termination on October 19, 2026, with severance benefits including nine months of base salary, 12 months of equity vesting acceleration, and a COBRA-related lump sum payment.

Mirum Pharmaceuticals announced positive results from Cohort 2 of the pivotal PROGRESS study of ATEBRIOZ (zilurgisertib) in pediatric patients aged 6 to <12 years with fibrodysplasia ossificans progressiva (FOP). The company plans to submit a supplemental New Drug Application (sNDA) in the first half of 2027 to expand the indication to this younger patient population.

Mirum Pharmaceuticals announced positive topline results from the Phase 3 EXPAND study of LIVMARLI (maralixibat) in ultra-rare cholestatic liver diseases, including biliary atresia. The study met its primary endpoint and all five prespecified secondary endpoints, and the company plans to submit a supplemental New Drug Application in the U.S. in the first half of 2027.

Mirum Pharmaceuticals and Incyte announced FDA approval of Atebrioz (zilurgisertib) for fibrodysplasia ossificans progressiva (FOP). Additionally, Mirum announced positive Phase 3 results for brelovitug in chronic hepatitis delta.

Mirum Pharmaceuticals announced the departure of Chief Medical Officer Joanne Quan, effective September 2, 2026, and the appointment of Rob Myers as her successor, expected to begin on September 21, 2026.