secwatch.observer — SEC 8-K summary
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Issuer:     Silexion Therapeutics Corp (SLXN)
CIK:        0002022416
Form:       8-K
Filed at:   2025-12-16T23:59:59+00:00
Accession:  0001178913-25-004067
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Silexion submits Phase 2/3 trial application for SIL204 in locally advanced pancreatic cancer
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- Submitted Phase 2/3 clinical trial application in Israel for SIL204, a siRNA therapy for locally advanced pancreatic cancer (LAPC).
- Phase 2/3 trial initiation planned for Q2 2026; follow-on regulatory filings in Germany/EU in Q1 2026.
- Preclinical data demonstrated up to 99.7% cancer cell inhibition across multiple KRAS mutations.
- Two completed species toxicology studies confirmed no systemic organ toxicity; positive German regulatory feedback received.
- Collaborating with Sheba Medical Center (top-10 global hospital) for Israeli trial; U.S. expansion after safety run-in.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2022416/000117891325004067/0001178913-25-004067-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2022416/000117891325004067/zk2534113.htm
  HTML page:      https://secwatch.observer/filing/0001178913-25-004067

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer