---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-009095"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2025-01-21T23:59:59+00:00"
generated_at: "2026-05-27T22:21:56.870875+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Disc Medicine aligns with FDA on bitopertin confirmatory trial design; NDA planned H2 2025

## Summary
- Achieved FDA alignment on APOLLO post-marketing trial design for bitopertin in EPP and XLP.
- Co-primary endpoints: monthly total sunlight time without pain and percent change in whole-blood PPIX.
- Plans to submit NDA for accelerated approval in H2 2025 based on Phase 2 BEACON and AURORA data.
- APOLLO trial to enroll ~150 patients aged 12+, randomized 1:1, 60 mg dose, double-blind placebo-controlled.
- Trial initiation expected by mid-2025; enrollment underway by potential accelerated approval date.

## SEC filing metadata
- accession: 0001193125-25-009095
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2025-01-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/0001193125-25-009095-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/d858127d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-009095
- JSON: https://secwatch.observer/filing/0001193125-25-009095.json
- Plain text: https://secwatch.observer/filing/0001193125-25-009095.txt

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