---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-084737"
form_type: "8-K"
ticker: "CERO"
cik: "0001870404"
company_name: "CERO THERAPEUTICS HOLDINGS, INC."
filed_at: "2025-09-05T23:59:59+00:00"
generated_at: "2026-05-17T08:05:33.452622+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# CERo Therapeutics receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia

## Summary
- FDA granted Fast Track Designation for CER-1236 in AML, adding to existing Orphan Drug Designation.
- Benefits include increased FDA interactions, potential priority review, rolling submission, and expanded access.
- Phase 1/1b study underway evaluating CER-1236 in relapsed/refractory AML, MRD-positive, or TP53-mutated MDS/AML.
- CEO Chris Ehrlich noted the designation validates program urgency and may accelerate development and market timeline.

## SEC filing metadata
- accession: 0001213900-25-084737
- form_type: 8-K
- ticker: CERO
- cik: 0001870404
- company_name: CERO THERAPEUTICS HOLDINGS, INC.
- filed_at: 2025-09-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1870404/000121390025084737/0001213900-25-084737-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1870404/000121390025084737/ea0256155-8k_cero.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-084737
- JSON: https://secwatch.observer/filing/0001213900-25-084737.json
- Plain text: https://secwatch.observer/filing/0001213900-25-084737.txt

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