Mirum reports four positive readouts, raises 2026 sales guidance to $715M-$720M
Mirum launched ATEBRIOZ in FOP and posted positive results across ATEBRIOZ, LIVMARLI and brelovitug studies while lifting full-year product sales guidance.
Mirum Pharmaceuticals reported third quarter 2026 results on November 3, 2026, with third quarter 2026 global net product sales of $185.7 million and full-year net product sales guidance raised to $715 million to $720 million.1
During the quarter the company received U.S. FDA approval of and launched ATEBRIOZ (zilurgisertib) to reduce the volume of total new heterotopic ossification in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).1 Mirum also reported positive results from Cohort 2 of the PROGRESS study of ATEBRIOZ in pediatric patients aged 6 to under 12 years with FOP.1
On the liver portfolio, the company reported that the LIVMARLI EXPAND Phase 3 study in additional rare cholestatic conditions, including biliary atresia, met the primary endpoint and achieved statistical significance across all prespecified secondary endpoints.1 For brelovitug in chronic hepatitis delta virus, Mirum reported that the AZURE-1 Phase 3 study met its primary endpoint, with full results to be presented in a late-breaking poster at AASLD's The Liver Meeting on November 8.1 Separately, the company reported positive 48-week data from the Phase 2b portion of AZURE-1, showing deepening viral suppression and increased rates of ALT normalization, with full results to be presented in an oral session on November 8.1 Brelovitug also received U.S. FDA Orphan Drug Designation for HDV.1
Looking ahead, Mirum said brelovitug AZURE-4 Phase 3 topline data in HDV are expected in Q4 2026, volixibat VANTAGE Phase 2b topline data in PBC are expected in Q1 2027, a volixibat NDA submission for PSC is planned for H1 2027, a LIVMARLI EXPAND supplemental NDA submission is planned for H1 2027, an ATEBRIOZ sNDA to expand into pediatric patients aged 6 to under 12 is planned for H1 2027, and a brelovitug BLA submission is planned for H1 2027, subject to supportive AZURE-4 results.1
On the balance sheet, the company said as of September 30, 2026, Mirum had unrestricted cash, cash equivalents, and investments of $500.5 million, compared to $391.4 million as of December 31, 2025.1 Mirum also repurchased $20.0 million aggregate principal amount of its 4.00% convertible senior subordinated notes due 2029, representing approximately 25% of the outstanding notes.1
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