Mirum Pharmaceuticals, Inc. — Form 8-K
Filed August 5, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 62/100
What the filing says
Mirum reported Q2 2026 net product sales of $176.2 million (up 38% YoY) and raised full-year guidance from prior levels to $680–700 million. LIVMARLI sales grew 46% to $128.7 million; Bile Acid Medicines grew 20% to $47.5 million. Volixibat received FDA Breakthrough Therapy and Orphan Drug designations for cholestatic pruritus due to PSC, but the FDA recommended an additional Phase 3 study at the pre-NDA meeting; NDA submission now targeted H1 2027. Mirum issued $690 million in 0% convertible notes due 2032 and settled $237.2 million (75%) of 4% convertible notes due 2029, increasing cash to $561.3 million. Zilurgisertib NDA has PDUFA date of September 26, 2026.
Why this rating
Strong Q2 sales growth and raised guidance (+$80M+ annualized) represent ~4% upside to market cap. Volixibat FDA setback (Phase 3 required vs. direct NDA) delays revenue by ~1 year but designations validate asset. Zilurgisertib imminent decision (Sept 26) and strong balance sheet ($561M cash) support pipeline execution.
See more from August 5, 2026.
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