Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals reported a 38% increase in Q2 2026 product sales, reaching $176.2 million, driven by strong performance from Livmarli and Bile Acid Medicines. However, the company posted a net loss of $(67.2) million, or $(1.06) per share, primarily due to a significant $742.7 million year-to-date acquired in-process research and development expense related to the acquisition of Bluejay Therapeutics in January 2026. As of June 30, 2026, Mirum held $561.3 million in unrestricted cash, cash equivalents, and investments, which it believes is sufficient for at least the next twelve months.

Mirum Pharmaceuticals, Inc. issued $690.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2032, including the full exercise of the initial purchasers' option. The notes are senior, unsecured obligations maturing on June 1, 2032, and do not bear regular interest. The initial conversion price is approximately $138.94 per share, representing a 30.0% premium over the company's common stock price on May 12, 2026. A portion of the net proceeds, along with common stock, will be used to refinance approximately $237.2 million of outstanding 4.00% convertible senior notes due 2029 through privately negotiated exchange transactions.

Mirum Pharmaceuticals, Inc. reported a significant net loss of $790.2 million for Q1 2026, primarily driven by a $726.3 million expense for acquired in-process research and development related to its acquisition of Bluejay Therapeutics, Inc. on January 23, 2026. Despite the substantial loss, product sales increased by 43.2% to $159.9 million, with Livmarli sales growing to $113.8 million. The acquisition adds worldwide rights to brelovitug, a late-stage monoclonal antibody for chronic hepatitis delta virus.

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.

Mirum Pharmaceuticals announced that its VISTAS Phase 2b study of volixibat, an investigational IBAT inhibitor, met its primary endpoint in patients with primary sclerosing cholangitis (PSC). Volixibat demonstrated a robust and statistically significant 2.72 point improvement in pruritus compared to placebo, supporting its potential as the first treatment for cholestatic pruritus in PSC patients. The safety profile was consistent with known IBAT inhibition effects, primarily gastrointestinal adverse events and liver enzyme elevations. The company plans a pre-NDA meeting with the FDA in summer 2026, with an NDA submission targeted for the second half of 2026, and expects topline data from its VANTAGE Phase 2b study in PBC in Q1 2027.

Mirum Pharmaceuticals, Inc. announced that its investigational monoclonal antibody, brelovitug, met the primary endpoint in the Phase 2b portion of the AZURE-1 study for chronic hepatitis delta virus (HDV). At Week 24, the 300 mg once weekly arm showed a 100% virologic response, and the 900 mg once every four weeks arm showed a 75% response, significantly outperforming the delayed treatment arm. The drug was well tolerated, with further reductions in ALT and HDV RNA levels observed after 24 weeks. The company expects topline data from Phase 3 studies in H2 2026, with potential BLA submission and commercial launch in 2027.