---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-051504"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2026-02-13T23:59:59+00:00"
generated_at: "2026-05-16T02:48:39.387221+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA for EPP; approval delayed

## Summary
- FDA acknowledged bitopertin significantly lowers PPIX but found insufficient evidence that PPIX change predicts clinical benefit.
- Phase 3 APOLLO study ongoing; topline data expected Q4 2026; could support traditional approval.
- Company plans Type A meeting with FDA; expects resubmission and decision by mid-2027 if APOLLO successful.
- Disc Medicine has approximately $791M cash (unaudited, Dec 31, 2025) with runway into 2029.
- CRL delays potential approval; stock likely to face negative pressure.

## SEC filing metadata
- accession: 0001193125-26-051504
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2026-02-13T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1816736/000119312526051504/0001193125-26-051504-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000119312526051504/iron-20260213.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-051504
- JSON: https://secwatch.observer/filing/0001193125-26-051504.json
- Plain text: https://secwatch.observer/filing/0001193125-26-051504.txt

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