Mirum In-licenses Zilurgisertib; Q1 Sales $159.9M, Raises Guidance
Mirum Pharmaceuticals reported strong financial results for Q1 2026, with net product sales reaching $159.9 million, and subsequently raised its full-year 2026 net product sales guidance to $660 million to $680 million. The company also announced the in-licensing of exclusive worldwide rights to zilurgisertib for fibrodysplasia ossificans progressiva (FOP), which has received FDA Priority Review with a PDUFA date of September 26, 2026. Additionally, Mirum achieved positive primary endpoints in its Volixibat VISTAS Phase 2b study and Brelovitug AZURE-1 Phase 2b study. Despite these operational and pipeline successes, the company reported a significant net loss of $790.155 million for the quarter, largely driven by a non-recurring $726.3 million in-process research and development expense related to an acquisition.
Key Highlights
- Mirum Pharmaceuticals in-licensed exclusive worldwide rights to zilurgisertib for FOP; FDA Priority Review granted with September 26, 2026 PDUFA date.
- Reported Q1 2026 net product sales of $159.9 million, up from $111.6 million in Q1 2025.
- Increased 2026 net product sales guidance to $660 million to $680 million.
- Volixibat VISTAS Phase 2b study in PSC met primary endpoint; U.S. NDA submission expected in H2 2026.
- Brelovitug AZURE-1 Phase 2b study in chronic HDV met primary endpoint.
- LIVMARLI net product sales were $113.8 million in Q1 2026, representing 55% growth over Q1 2025.
- Reported a net loss of $790.155 million for Q1 2026, primarily due to a $726.3 million non-recurring IPR&D expense.
- Ended Q1 2026 with $420.6 million in unrestricted cash, cash equivalents, and investments.