Silexion Therapeutics Corp. has announced the submission of its regulatory application in Israel to initiate a Phase 2/3 clinical trial of SIL204 for patients with locally advanced pancreatic cancer. This regulatory submission follows positive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) and successful toxicology studies demonstrating no systemic organ toxicity. Silexion plans to file additional regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated after the safety run-in is completed in Israel and Germany. The Israeli portion of the trial will be conducted in collaboration with Sheba Medical Center, pending regulatory and ethics approvals.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Silexion Therapeutics Corp. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001145194-en) on December 16, 2025, and is solely responsible for the information contained therein.
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