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Get filing alertsMirum reports Q1 sales of $159.9M, raises 2026 guidance to $660-680M, announces trial wins
Filed May 6, 2026 · Period ending May 6, 2026 · ~1 min read
Key Changes
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Q1 2026 net product sales reached $159.9M, driven by LIVMARLI growth of 55% year-over-year to $113.8M. Full-year 2026 revenue guidance raised to $660-680M, reflecting strong commercial momentum across the portfolio.
Exhibit 99.1 view on EDGAR → -
high
Volixibat Phase 2b VISTAS study in primary sclerosing cholangitis met its primary endpoint. Full results to be presented at EASL on May 30, with U.S. NDA submission expected in H2 2026.
Exhibit 99.1 view on EDGAR → -
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Brelovitug Phase 2b portion of AZURE-1 study in chronic hepatitis delta virus met its primary endpoint. Phase 3 enrollment complete in AZURE-1 and AZURE-4 studies, with topline results expected in H2 2026.
Exhibit 99.1 view on EDGAR → -
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In-licensed zilurgisertib from Incyte for $16M upfront plus milestones and mid-to-high single-digit royalties. FDA granted Priority Review with PDUFA date of September 26, 2026 for fibrodysplasia ossificans progressiva in patients 12 years and older.
Exhibit 99.1 view on EDGAR → -
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Recorded $726.3M non-recurring IPR&D expense and $34.7M non-recurring stock-based compensation related to Bluejay Therapeutics acquisition, driving Q1 net loss to $790.2M versus $126.8M operating expenses in Q1 2025.
Exhibit 99.1 view on EDGAR →
Summary
Mirum delivered a strong operational quarter with Q1 2026 sales of $159.9 million and raised full-year guidance to $660-680 million, reflecting 55% year-over-year growth in its lead product LIVMARLI. The company advanced two clinical programs to potential near-term commercialization: volixibat met its Phase 2b primary endpoint in primary sclerosing cholangitis with NDA submission planned for H2 2026, and brelovitug met its Phase 2b endpoint in chronic hepatitis delta virus with Phase 3 topline results also expected in H2 2026. Mirum expanded its rare disease portfolio by in-licensing zilurgisertib from Incyte for fibrodysplasia ossificans progressiva, with FDA Priority Review and a September 2026 PDUFA date providing a potential near-term launch opportunity.
The quarter's reported net loss of $790.2 million was driven by non-recurring charges totaling $761 million related to the Bluejay Therapeutics acquisition—a $726.3 million IPR&D expense and $34.7 million in stock-based compensation. These non-cash accounting charges do not affect the company's commercial trajectory or cash position. Investors should watch for full clinical data presentations at EASL in late May and the zilurgisertib FDA decision in September, both of which could materially expand Mirum's commercial footprint in rare liver and genetic diseases.
Section-by-Section Diff
Event · Item 2.02 — Results of Operations and Financial Condition
Mirum announced Q1 2026 financial results and corporate update via press release.
Added in current filing · verify on EDGAR →
On May 6, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the quarter ended March 31, 2026.
The company disclosed its financial results for the first quarter ended March 31, 2026, along with a corporate update. The specific financial metrics and operational details are contained in the press release furnished as Exhibit 99.1, which is not included in the 8-K body text.
Event · Exhibit 99.1
Mirum reported Q1 2026 sales of $159.9M, raised 2026 guidance to $660-680M, announced positive Phase 2b trial results, and in-licensed zilurgisertib for FOP.
Added in current filing · view on EDGAR → · paraphrased
First quarter 2026 global net product sales of $159.9 million. ... 2026 net product sales guidance increased to $660 to $680 million
Mirum reported Q1 2026 net product sales of $159.9 million, with LIVMARLI sales of $113.8 million (55% year-over-year growth) and Bile Acid Medicines sales of $46.1 million (20% growth). The company raised its full-year 2026 revenue guidance to $660-680 million, reflecting strong commercial momentum across its product portfolio.
Added in current filing · view on EDGAR →
Entered into an exclusive license agreement with Incyte for worldwide rights to zilurgisertib, an ALK2 inhibitor in development for fibrodysplasia ossificans progressiva (FOP). ... U.S. FDA accepted the New Drug Application (NDA) for zilurgisertib in FOP patients 12 years and older and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026. ... In return for the exclusive license of worldwide rights to zilurgisertib, Incyte received an upfront payment of $16 million and is eligible to receive additional development and regulatory milestone payments, as well as sales-based milestones and tiered royalties on worldwide net sales in the mid-to-high single digit percent range.
Mirum in-licensed exclusive worldwide rights to zilurgisertib from Incyte for $16 million upfront plus milestones and mid-to-high single-digit royalties. The FDA accepted the NDA for zilurgisertib in fibrodysplasia ossificans progressiva with Priority Review and a PDUFA date of September 26, 2026. This adds a potential near-term product launch to Mirum's rare genetic disease portfolio.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 23, 2026 · How we verify