Every material Form 8-K Mirum Pharmaceuticals, Inc. has filed with the SEC since October 13, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Mirum reported third quarter 2026 product sales of $185.7 million, up from $133.0 million a year earlier, and raised its full-year 2026 net product sales guidance to $715 million to $720 million. The company swung to a third-quarter net loss of $40.8 million, or $0.87 per diluted share, from net income of $2.9 million a year earlier, as operating expenses rose to $245.5 million.
Q3 2026 revenue of $185.7 million versus $133.0 million in Q3 2025; LIVMARLI net product sales of $133.4 million, up 45%
Q3 2026 net loss of $40.8 million, or $0.87 per diluted share, versus net income of $2.9 million, or $0.05 per diluted share, in Q3 2025
Q3 2026 research and development expense of $107.9 million, including $13.5 million of acquired in-process research and development
Unrestricted cash, cash equivalents and investments of $500.5 million at September 30, 2026, up from $391.4 million at December 31, 2025
Mirum Pharmaceuticals said its 25-patient Cohort 2 trial of ATEBRIOZ (zilurgisertib) in children aged 6 to under 12 with fibrodysplasia ossificans progressiva showed reduced heterotopic ossification lesion volume and improved joint mobility at Week 24 compared with placebo. The company plans to submit a supplemental New Drug Application in the first half of 2027 to expand the approved indication to this age group.
Mean total HO lesion volume fell 8.09 cm³ with ATEBRIOZ versus a 9.14 cm³ increase with placebo (nominal p=0.003).
No ATEBRIOZ-treated patients developed new HO lesions, compared with 1 patient (7.7%) on placebo.
Mean CAJIS joint mobility score improved 0.80 points with ATEBRIOZ versus 0.09 points with placebo at Week 24.
The company plans a supplemental NDA submission in the first half of 2027; full Cohort 2 results will be presented at an upcoming medical meeting.
Mirum Pharmaceuticals announced topline results from the Phase 3 EXPAND study of Livmarli (maralixibat) in ultra-rare cholestatic liver diseases, saying the study met its primary endpoint. In the pediatric primary analysis, pruritus improved 1.81 points from baseline on maralixibat versus 0.83 points on placebo, and the company plans to submit a U.S. supplemental New Drug Application in the first half of 2027.
Primary endpoint: 1.81-point improvement on maralixibat vs. 0.83 on placebo, a placebo-adjusted difference of 0.98 points (p=0.0004)
Serum bile acids fell 70.1% on maralixibat vs. 3.5% on placebo, a 69.0% treatment effect (p<0.0001)
No new safety signals; diarrhea reported in 64.0% of maralixibat patients vs. 11.1% on placebo
Supplemental New Drug Application planned in the United States in the first half of 2027
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