---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-424649"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2026-10-19T11:08:08+00:00"
generated_at: "2026-10-19T11:10:08.309383+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.92
calibrated_materiality_score: 0.92
confidence: "high"
source: SEC EDGAR
---

# Disc Medicine's bitopertin meets all Phase 3 APOLLO endpoints in EPP; NDA resubmission planned for end-2026

## Summary
- Phase 3 APOLLO enrolled 183 EPP/XLP patients aged 12+ across US, Canada, Europe, Australia; randomized 1:1 to 60 mg oral bitopertin or placebo for 6 months.
- Co-primary endpoints met: whole-blood metal-free PPIX fell 41.4% vs placebo (p<0.0001); average monthly pain-free light time rose 12.2 hours in month 6 (p=0.0010).
- All secondary endpoints significant: lower phototoxic reaction incidence (p<0.0001), more cumulative pain-free light time (p<0.0001), improved PGIC and PGIS scores (p<0.0001).
- Dizziness was most common TEAE at 50%, mild/moderate and generally transient; no TEAEs above Grade 3 and no new safety signals.
- Disc plans NDA resubmission to FDA by end-2026, with FDA decision anticipated by mid-2027; webcast Oct 19, 2026 at 8:00am ET.

## SEC filing metadata
- accession: 0001193125-26-424649
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2026-10-19T11:08:08+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.92
- calibrated_materiality_score: 0.92
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/0001193125-26-424649-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/d156263d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-424649
- JSON: https://secwatch.observer/filing/0001193125-26-424649.json
- Plain text: https://secwatch.observer/filing/0001193125-26-424649.txt

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