Silexion Therapeutics received positive feedback from the German Health Authority regarding the design of its planned Phase 2/3 clinical trial for SIL204 in pancreatic cancer.
The feedback reinforces Silexion's progress towards initiating the Phase 2/3 trial in Q2 2026.
The Company is moving forward with regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and to Germany during Q1 2026.
Regulatory Milestone
Positive response from the German Health Authority marks an important regulatory milestone for Silexion in advancing its SIL204 trial.
Upcoming Regulatory Submissions
Plans to submit regulatory documents to the Israeli Ministry of Health before the end of 2025 and to Germany by Q1 2026.
Phase 2/3 Trial Initiation
On track to commence the Phase 2/3 clinical trial of SIL204 in pancreatic cancer in the first half of 2026.
- The positive feedback and regulatory clarity from the German Health Authority validate Silexion's clinical trial design and support necessary submissions.
- Silexion's progress on SIL204 remains on schedule, with focus on bringing the therapy into the clinic for potential treatment advancements in KRAS-mutated cancers.
The supportive response from the German Health Authority signifies a significant step in Silexion's regulatory journey towards advancing its lead product candidate, SIL204, for pancreatic cancer treatment.