---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-079310"
form_type: "8-K"
ticker: "MRKR"
cik: "0001094038"
company_name: "Marker Therapeutics, Inc."
filed_at: "2023-07-10T23:59:59+00:00"
generated_at: "2026-06-13T10:27:38.564766+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Marker Therapeutics' MT-401 receives EMA Orphan Drug Designation for AML

## Summary
- EMA granted Orphan Drug Designation for zedenoleucel (MT-401) for acute myeloid leukemia (AML).
- MT-401 is a non-genetically modified multiTAA-specific T cell therapy targeting four AML-associated antigens.
- Phase 2 trial ongoing for relapsed AML after allogeneic HSCT; FDA also granted orphan designation in 2020.
- Benefits include 10-year EU market exclusivity post-approval, reduced regulatory fees, and scientific advice.
- Relapsed AML after HSCT has median survival <1 year, underscoring the need for new therapies.

## SEC filing metadata
- accession: 0001104659-23-079310
- form_type: 8-K
- ticker: MRKR
- cik: 0001094038
- company_name: Marker Therapeutics, Inc.
- filed_at: 2023-07-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1094038/000110465923079310/0001104659-23-079310-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1094038/000110465923079310/tm2320895d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-079310
- JSON: https://secwatch.observer/filing/0001104659-23-079310.json
- Plain text: https://secwatch.observer/filing/0001104659-23-079310.txt

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