---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-092435"
form_type: "8-K"
ticker: "EQ"
cik: "0001746466"
company_name: "Equillium, Inc."
filed_at: "2025-04-24T23:59:59+00:00"
generated_at: "2026-05-23T07:09:54.473750+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Equillium announces FDA declined Breakthrough Therapy and Accelerated Approval for itolizumab in aGVHD

## Summary
- FDA declined Breakthrough Therapy designation and Accelerated Approval for itolizumab in aGVHD based on EQUATOR study data.
- FDA focused on Day 29 outcomes; itolizumab did not show improvement by Day 29 despite favorable safety and longer-term data.
- Company plans to accelerate closure of EQUATOR study and evaluate options to advance or partner itolizumab.
- Cash and equivalents $14.5M as of March 31, 2025; expected to fund operations into Q3 2025.

## SEC filing metadata
- accession: 0001193125-25-092435
- form_type: 8-K
- ticker: EQ
- cik: 0001746466
- company_name: Equillium, Inc.
- filed_at: 2025-04-24T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1746466/000119312525092435/0001193125-25-092435-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1746466/000119312525092435/d787196d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-092435
- JSON: https://secwatch.observer/filing/0001193125-25-092435.json
- Plain text: https://secwatch.observer/filing/0001193125-25-092435.txt

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