---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-26-002267"
form_type: "8-K"
ticker: "SLXN"
cik: "0002022416"
company_name: "Silexion Therapeutics Corp"
filed_at: "2026-04-28T23:59:59+00:00"
generated_at: "2026-05-15T03:15:46.656229+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Silexion submits Phase 2/3 trial application to Germany's BfArM for SIL204 in KRAS-driven pancreatic cancer

## Summary
- Silexion submitted CTA to Germany’s BfArM for Phase 2/3 trial of SIL204 in KRAS-driven locally advanced pancreatic cancer.
- Germany will serve as EU Reference Member State; trial initiation remains on track for Q2 2026.
- Submission supported by completed two-species toxicology studies confirming no systemic organ toxicity.
- Planned trial will evaluate SIL204 in combination with standard chemotherapy using dual-route administration.
- Pancreatic cancer has <13% five-year survival; KRAS mutations present in about 90% of cases.

## SEC filing metadata
- accession: 0001178913-26-002267
- form_type: 8-K
- ticker: SLXN
- cik: 0002022416
- company_name: Silexion Therapeutics Corp
- filed_at: 2026-04-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2022416/000117891326002267/0001178913-26-002267-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2022416/000117891326002267/zk2635144.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-26-002267
- JSON: https://secwatch.observer/filing/0001178913-26-002267.json
- Plain text: https://secwatch.observer/filing/0001178913-26-002267.txt

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