---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-053066"
form_type: "8-K"
ticker: "IRON"
cik: "0001816736"
company_name: "Disc Medicine, Inc."
filed_at: "2026-02-17T23:59:59+00:00"
generated_at: "2026-05-16T02:30:40.721420+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA in erythropoietic protoporphyria

## Summary
- FDA issued a Complete Response Letter on February 13, 2026 for bitopertin NDA for erythropoietic protoporphyria (EPP).
- The CRL indicates FDA will not approve the NDA in its current form, typically requiring additional data or analyses.
- Disc Medicine hosted a conference call on February 17, 2026 to discuss the CRL and next steps; webcast available for 30 days.
- Bitopertin is Disc Medicine's lead product candidate; this regulatory setback materially impacts the company's pipeline.

## SEC filing metadata
- accession: 0001193125-26-053066
- form_type: 8-K
- ticker: IRON
- cik: 0001816736
- company_name: Disc Medicine, Inc.
- filed_at: 2026-02-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1816736/000119312526053066/0001193125-26-053066-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1816736/000119312526053066/iron-20260217.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-053066
- JSON: https://secwatch.observer/filing/0001193125-26-053066.json
- Plain text: https://secwatch.observer/filing/0001193125-26-053066.txt

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