secwatch.observer — SEC 8-K summary
======================================

Issuer:     Mirum Pharmaceuticals, Inc. (MIRM)
CIK:        0001759425
Form:       8-K
Filed at:   2026-09-28T12:02:47+00:00
Accession:  0001759425-26-000049
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

FDA approves Mirum/Incyte's Atebrioz for FOP; brelovitug meets AZURE-1 Phase 3 primary endpoint
--------------------------------------------------------------------------------

- FDA approved Atebrioz (zilurgisertib) 100 mg once daily to reduce total new heterotopic ossification volume in FOP patients aged 12+; U.S. launch expected October 2026.
- In PROGRESS Cohort 1, Week 24 mean new HO lesion volume fell 3.2 cm3 with zilurgisertib vs increase of 24.6 cm3 on placebo; effects maintained through Week 48.
- Phase 3 AZURE-1: brelovitug met primary endpoint with 56% (300 mg QW) and 45% (900 mg Q4W) vs 0% delayed treatment (p<0.0001) in 153 treatment-naive chronic HDV patients.
- Brelovitug BLA submission expected H1 2027 and U.S. launch Q4 2027; AZURE-4 topline due Q4 2026. Mirum estimates >$1B annual revenue potential for brelovitug and >$200M for Atebrioz.
- Week 48 Phase 2b data showed deepening response: 300 mg QW primary endpoint rate rose from 45% to 55%, 900 mg Q4W from 35% to 55%; no new safety signals.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759425/000175942526000049/0001759425-26-000049-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759425/000175942526000049/mirm-20260925.htm
  HTML page:      https://secwatch.observer/filing/0001759425-26-000049

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer