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Silexion receives scientific advice from BfArM for Phase 2/3 clinical trial of SIL204.
ByAinvest
Tuesday, Dec 2, 2025 8:06 am ET1min read
Silexion Therapeutics has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of its planned Phase 2/3 clinical trial for SIL204, its lead product candidate for locally advanced pancreatic cancer. The guidance provides significant regulatory clarity as the company prepares its clinical trial submissions. Silexion plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026, with Phase 2/3 trial initiation planned for Q2 2026.
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