---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-242026"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2025-10-17T23:59:59+00:00"
generated_at: "2026-05-17T03:25:07.434873+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Disc Medicine receives FDA priority voucher for bitopertin in EPP; review time cut to 1-2 months

## Summary
- FDA granted CNPV for bitopertin in erythropoietic protoporphyria (EPP) including X-linked protoporphyria.
- NDA submitted September 2025 under accelerated approval pathway for patients aged 12+.
- CNPV program reduces standard FDA review to 1-2 months; includes rolling review and enhanced communications.

## SEC filing metadata
- accession: 0001193125-25-242026
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2025-10-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816736/000119312525242026/0001193125-25-242026-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000119312525242026/iron-20251016.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-242026
- JSON: https://secwatch.observer/filing/0001193125-25-242026.json
- Plain text: https://secwatch.observer/filing/0001193125-25-242026.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.