Silexion Therapeutics (SLXN) announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer, LAPC, based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices, BfArM. The submission represents a key regulatory milestone in the Company’s clinical development program and advances Silexion toward initiating human trials with SIL204, which are planned for the second quarter of 2026. The application is further supported by two recently completed species toxicology studies confirming no systemic organ toxicity. Silexion plans to file regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated following completion of the safety run-in in Israel and Germany.
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