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health42m ago
Silexion Therapeutics Receives Positive Feedback on Clinical Trial Design
- German Health Authority issues positive feedback on Silexion's Phase 2/3 trial design, supporting a Q2 2026 initiation.
- Israel and Germany regulatory activity planned: submissions expected by end of 2025 in Israel and Q1 2026 in Germany.
- Feedback covers clinical design, dosing, and manufacturing aspects of the trial.
- Trial aims to address unmet needs in KRAS-mutated cancers.
- Silexion Therapeutics plans Phase 2/3 trial initiation in 2026 following regulatory feedback.
- The information reflects SEC filings and should be verified against primary sources.
- Regulatory steps include future submissions in multiple jurisdictions beyond Germany and Israel.
- Trial design feedback focuses on dosing and manufacturing implications for KRAS-targeted therapies.
- The announcement aligns with the company's strategy to advance KRAS-mutated cancer therapies.
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