Mirum

1 products tracked · names used in filings: Mirum, Mirum Pharmaceuticals, Inc.

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Sat 26 Sep 2026🇺🇸 PDUFA datecompany-announced

zilurgisertib: PDUFA target action date (fibrodysplasia ossificans progressiva (FOP))

Mirum Pharmaceuticals, Inc. (MIRM); zilurgisertib; NDA; status: set; "…Presented positive pivotal Phase 2 results from the PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva (FOP) at ENDO 2026; Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026."; filed 2026-08-05 · source

Fri 25 Sep 2026🇺🇸 FDA approval

FDA approves Atebrioz (zilurgisertib fumarate), a new medicine

Mirum; NDA221198; New molecular entity, Priority review; tablet · source

Products

ProductStatusApproved
🇺🇸Atebrioz
zilurgisertib fumarate		Approved2026-09-25

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.