Mirum Pharmaceuticals Inc
F:08D
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Mirum Pharmaceuticals Inc
F:08D
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Earnings Calls
Last Earnings Call
Sales: Mirum reported second-quarter net product sales of $176 million, well above the year-ago $128 million, and raised full-year 2026 sales guidance to $680 million to $700 million.
PSC setback: The FDA asked for a Phase 3 study for volixibat in PSC after a pre-NDA discussion, pushing the planned NDA filing into the first half of next year.
Breakthroughs: The FDA granted breakthrough therapy designation for volixibat in PSC, while VANTAGE in PBC is progressing with positive regulatory feedback and over 330 patients randomized.
Launch prep: Mirum said the late-cycle meeting for zilurgisertib went well and it is preparing for a potential fourth-quarter U.S. launch ahead of the September PDUFA date.
Balance sheet: The company issued $690 million of 0% convertible notes due in June 2032, used the proceeds to retire most of its 2029 notes, and ended the quarter with $561 million in cash, cash equivalents and investments.