# MIRM PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MIRM
Company: Mirum Pharmaceuticals

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with MIRM.

## MIRM PDUFA Milestones

- 2024-03-13 — FDA Approval — FDA approved application. FDA recorded approval of LIVMARLI on March 13, 2024. This list-only historical record is sourced from the official FDA application...
  Company: Mirum Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214662
  Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/livmarli-nda-214662-suppl-5.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024)
- 2024-07-24 — FDA Approval — FDA approved application. FDA recorded approval of LIVMARLI on July 24, 2024. This list-only historical record is sourced from the official FDA application d...
  Company: Mirum Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214662
  Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/livmarli-nda-214662-suppl-10.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/july (July 2024)
- 2025-02-21 — FDA Approval — FDA approved application. FDA recorded approval of CTEXLI on February 21, 2025. This list-only historical record is sourced from the official FDA application...
  Company: Mirum Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219488
  Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/ctexli-nda-219488-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/february (February 2025)
- 2025-04-10 — FDA Approval — FDA approved application. FDA recorded approval of LIVMARLI on April 10, 2025. This list-only historical record is sourced from the official FDA application...
  Company: Mirum Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219485
  Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/livmarli-nda-219485-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025)
- 2026-09-26 — PDUFA — FDA approved ATEBRIOZ for fibrodysplasia ossificans progressiva. FDA approved ATEBRIOZ tablets to reduce the volume of total new heterotopic ossification in...
  Company: Mirum Pharmaceuticals
  Source: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-third-treatment-fibrodysplasia-ossificans-progressiva
  Event detail: https://biopharmsignal.com/pdufa-calendar/MIRM/zilurgisertib-fibrodysplasia-ossificans-progressiva.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/MIRM
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the MIRM PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with MIRM, including decision dates, application stage, and summary details when available.
### Where can I find more context for MIRM?

Use the BioPharmSignal company page for MIRM to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.
