Silexion Therapeutics Announces Initiation of GMP Clinical Supply Manufacturing of SIL204 with Leading Global CDMO, and New Approval of Phase 2/3 Trial From Tel Aviv Sourasky Medical Center

Silexion Therapeutics has initiated GMP clinical manufacturing of SIL204, its next-generation siRNA therapy targeting mutated KRAS in pancreatic cancer, in collaboration with CDMO Catalent at its Limoges, France facility. The company received approval from Tel Aviv Sourasky Medical Center's Helsinki Ethics Committee for its planned Phase 2/3 trial in locally advanced pancreatic cancer, following earlier approvals from the Israeli Ministry of Health and a clinical trial application submission to Germany's BfArM.

05/13/2026, 8:00 AM • GlobeNewswire

Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer

Silexion Therapeutics received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices regarding its planned Phase 2/3 clinical trial for SIL204, a potential treatment for locally advanced pancreatic cancer. The guidance provides regulatory clarity and supports the company's planned trial initiation in Q2 2026.

12/02/2025, 8:00 AM • GlobeNewswire

Silexion Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update

Silexion Therapeutics reported strong preclinical results for SIL204, a potential cancer therapy targeting KRAS mutations, raised $9.5 million in financing, and remains on track to initiate Phase 2/3 clinical trials in the first half of 2026.

11/12/2025, 9:00 AM • GlobeNewswire

Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach and Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration

Silexion Therapeutics demonstrated successful systemic distribution of SIL204 to major pancreatic cancer metastatic sites in preclinical studies, showing tumor burden reductions across liver, peritoneum, and lung, with plans to initiate Phase 2/3 trials in H1 2026.

09/11/2025, 7:00 AM • GlobeNewswire

Silexion Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

Silexion Therapeutics reported strong preclinical data for SIL204 across multiple KRAS-driven cancer types, demonstrating up to 97% cancer cell inhibition. The company is preparing to initiate Phase 2/3 clinical trials in 2026 and maintains its Nasdaq listing after a reverse stock split.

08/12/2025, 8:00 AM • GlobeNewswire