Mirum Raises 2026 Sales Outlook After Second Guidance Lift

The Tip Desk · August 5, 2026 · 3 min read

The rare disease company lifted 2026 net product sales guidance to $680 million to $700 million after second-quarter sales of $176.2 million.

Mirum Pharmaceuticals (MIRM), a rare disease company, raised its 2026 net product sales outlook to $680 million to $700 million after a second consecutive quarterly lift, following first-quarter sales of $176.2 million.

The company had guided to $660 million to $680 million after the first quarter. Chief Executive Officer Chris Peetz said continued commercial momentum supported the increase and launch readiness for a potential zilurgisertib approval.

Second-quarter LIVMARLI net product sales were $128.7 million, up 46% from a year earlier. That year-over-year rate slowed from 55% in the first quarter. Bile Acid Medicines contributed $47.5 million, matching the 20% year-over-year growth reported in the prior quarter.

Total revenue for the three months ended June 30, 2026, was $176.2 million. Net loss widened to $67.2 million, or $1.06 a share, from $5.9 million, or $0.12 a share, a year earlier.

Operating expenses were $218.8 million, including $16.4 million of non-recurring acquired in-process research and development tied to the exclusive worldwide license of zilurgisertib from Incyte. Research and development expense was $76.3 million, including $28.8 million for brelovitug. Selling, general, and administrative expense was $65.6 million, excluding stock-based compensation. Cost of sales was $23.2 million, excluding intangible amortization and stock-based compensation. The quarter also included $37.3 million of stock-based compensation, intangible amortization, and other non-cash expenses.

The FDA granted volixibat Breakthrough Therapy and Orphan Drug Designations for cholestatic pruritus due to primary sclerosing cholangitis. After a pre-NDA meeting, the agency recommended a Phase 3 study. The company intends to hold further discussions before a potential NDA submission now targeted in the first half of 2027, later than the second-half 2026 U.S. NDA submission expected after the first quarter.

Enrollment completed in the VANTAGE Phase 2b study of volixibat in cholestatic pruritus due to primary biliary cholangitis, with topline results expected in the first quarter of 2027. Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus are expected to report topline results in the third and fourth quarters of 2026. LIVMARLI EXPAND Phase 3 topline results in additional rare cholestatic conditions are expected in the fourth quarter of 2026.

The FDA accepted the zilurgisertib NDA for fibrodysplasia ossificans progressiva under Priority Review, with a PDUFA target of September 26, 2026. The company presented positive pivotal Phase 2 results from the PROGRESS study at ENDO 2026.

The company issued $690.0 million aggregate principal amount of 0.00% convertible senior notes due 2032 and settled $237.2 million of 4.00% convertible notes due 2029, about 75% of the then-outstanding notes. Unrestricted cash, cash equivalents, and investments were $561.3 million as of June 30, 2026.

Peetz said the FDA’s designations underscored the strength of VISTAS efficacy data and unmet need in PSC. VISTAS met its primary endpoint.