---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-120292"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2024-11-04T23:59:59+00:00"
generated_at: "2026-05-30T06:15:02.666531+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Disc Medicine gets FDA alignment on Phase 3 plan for bitopertin in EPP; accelerated approval possible

## Summary
- FDA agreed on all APOLLO trial parameters: single placebo-controlled study, 60 mg dose, 6-month duration, primary endpoint of monthly sunlight time without pain.
- Potential for accelerated approval using PPIX reduction as surrogate endpoint, allowing NDA submission based on existing data.
- APOLLO trial to include EPP and XLP patients aged 12+; initiation planned by mid-2025.
- Company to meet FDA to finalize details; update on NDA timing expected Q1 2025.
- Positive FDA feedback provides clear registration path for bitopertin in erythropoietic protoporphyria.

## SEC filing metadata
- accession: 0000950170-24-120292
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2024-11-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816736/000095017024120292/0000950170-24-120292-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000095017024120292/iron-20241104.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-120292
- JSON: https://secwatch.observer/filing/0000950170-24-120292.json
- Plain text: https://secwatch.observer/filing/0000950170-24-120292.txt

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