Silexion receives positive feedback from German Health Authority for SIL204

Silexion Therapeutics (SLXN) announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices regarding the proposed design of the Company’s planned Phase 2/3 clinical trial for SIL204, the Company’s lead product candidate for locally advanced pancreatic cancer. The guidance follows the Company’s Scientific Advice meeting held with BfArM recently and provides significant regulatory clarity as Silexion prepares its Phase 2/3 clinical trial submissions. The positive response from BfArM is an important milestone for supporting the acceptability of the proposed Phase 2/3 study design, based on the supporting safety data, and manufacturing specifications. The written feedback covers several core components of the program, including clinical design, dosing plans, patient population strategy, nonclinical support, and CMC/manufacturing considerations, and will be incorporated into Silexion’s upcoming regulatory submissions in Israel, which are expected by the end of 2025, and in Germany, which are expected during the first quarter of 2026.