Silexion Submits Pivotal Phase 2/3 CTA for Pancreatic Cancer Drug to Germany, Expanding EU Trial
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Silexion Therapeutics has successfully submitted its Phase 2/3 Clinical Trial Application (CTA) to Germany's BfArM for SIL204, its lead siRNA product candidate targeting KRAS-driven locally advanced pancreatic cancer. This submission is a critical regulatory milestone, positioning Germany as the Reporting Member State for the EU program and expanding the company's clinical development into a major European market. This follows prior positive Scientific Advice from BfArM and recent approval from the Israeli Ministry of Health for the same trial. For a micro-cap biotech company with a recent 'going concern' warning, this progress in its lead clinical program is highly material, de-risking the asset and potentially aiding future financing efforts. Traders will now monitor for BfArM approval and the planned Q2 2026 initiation of the Phase 2/3 trial.
في وقت هذا الإعلان، كان SLXN يتداول عند ٠٫٧٦ US$ في NASDAQ ضمن قطاع Life Sciences، مع قيمة سوقية تقارب ٣ مليون US$. تراوح نطاق التداول خلال 52 أسبوعًا بين ٠٫٧٠ US$ و٢٢٫٣٦ US$. تم تقييم هذا الخبر على أنه ذو معنويات سوقية إيجابية وبدرجة أهمية ٨ من 10. المصدر: GlobeNewswire.