---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-054961"
form_type: "8-K"
ticker: "CERO"
cik: "0001870404"
company_name: "CERO THERAPEUTICS HOLDINGS, INC."
filed_at: "2025-06-17T23:59:59+00:00"
generated_at: "2026-05-19T05:13:09.170868+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants Orphan Drug Designation to CERo's CER-1236 for AML treatment

## Summary
- FDA Orphan Drug Designation granted to CER-1236 for acute myeloid leukemia (AML).
- CER-1236 is an engineered T cell therapy leveraging phagocytic mechanisms; currently in Phase 1 trial.
- ODD qualifies CERo for 7-year marketing exclusivity, FDA trial assistance, and fee exemptions.
- AML is a life-threatening condition affecting ≤200,000 US patients annually.

## SEC filing metadata
- accession: 0001213900-25-054961
- form_type: 8-K
- ticker: CERO
- cik: 0001870404
- company_name: CERO THERAPEUTICS HOLDINGS, INC.
- filed_at: 2025-06-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1870404/000121390025054961/0001213900-25-054961-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1870404/000121390025054961/ea0245971-8k_cero.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-054961
- JSON: https://secwatch.observer/filing/0001213900-25-054961.json
- Plain text: https://secwatch.observer/filing/0001213900-25-054961.txt

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