Silexion Receives Regulatory Guidance for Phase 2/3 Trial of SIL204
Silexion Therapeutics 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.
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Silexion Finishes Toxicology Studies for SIL204; Phase 2/3 Trial for Pancreatic Cancer Set to Start in Q2
SIL204 Development: Silexion Therapeutics has completed toxicology studies for SIL204, a next-generation siRNA therapy targeting mutated KRAS oncogenes in pancreatic cancer, showing no systemic organ toxicity.
Therapeutic Potential: SIL204 has demonstrated significant inhibition of cancer cell growth in preclinical models and positive anti-tumor activity in pancreatic cancer, paving the way for regulatory submissions in Israel and Germany.
Clinical Trial Plans: The therapy is set to progress to a Phase 2/3 trial in Q2 2026, utilizing a unique regimen that combines intratumoral and systemic administration to evaluate safety and efficacy in patients with locally advanced pancreatic cancer.
Stock Performance: Silexion's stock has fluctuated between $2.13 and $63.45 over the past year, closing at $2.44, reflecting a 13.48% increase in recent trading.
Silexion Completes Toxicology Studies for SIL204, Plans Phase 2/3 Trial in 2026
- Successful Toxicology Studies: Silexion has completed dual-species toxicology studies for SIL204, confirming no systemic organ toxicity, which lays the groundwork for planned regulatory submissions in Israel and Germany, potentially accelerating clinical trial progress.
- Clinical Trial Timeline: The company is on track to initiate a Phase 2/3 clinical trial for locally advanced pancreatic cancer in Q2 2026, ensuring competitiveness and timely market entry in the oncology sector.
- Innovative Therapy Potential: SIL204, designed as a next-generation RNA interference therapy targeting mutant KRAS oncogenes, has demonstrated significant anti-tumor activity in vitro, indicating its substantial potential in treating aggressive cancers.
- Integrated Treatment Strategy: The company's approach combines both intratumoral and systemic administration, aiming to improve survival rates for patients suffering from high-mortality cancers that currently lack effective treatment options.
Silexion Therapeutics Meets Nasdaq Listing Standards Again
Regaining Compliance: Silexion Therapeutics has regained compliance with Nasdaq listing rules regarding minimum bid price and shareholders' equity, confirming a minimum bid price of $1.00 per share and $2.5 million in shareholders' equity.
Clinical Development Focus: The company is advancing towards Phase 2/3 clinical trials for its RNAi therapy SIL204, which has shown promising preclinical results in inhibiting KRAS-driven cancers, and is committed to developing innovative treatments for solid tumor cancers.
Silexion Therapeutics Stock Rises Following Encouraging Preclinical Results for Pancreatic Cancer
Stock Performance: Silexion Therapeutics Corp. (SLXN) stock rose 14.83% to $5.15 on Thursday, with a trading volume significantly higher than its average, following the release of promising preclinical data.
Preclinical Study Findings: New data shows that SIL204 effectively targets pancreatic cancer metastasis, demonstrating anti-tumor activity and significant reductions in tumor burden across multiple organs in a mouse model, supporting its potential for clinical trials.
What’s Behind the 190% Surge in Silexion Therapeutics Stock (SLXN) Today?
Stock Performance: Silexion Therapeutics (SLXN) stock surged 188.07% in pre-market trading after positive pre-clinical data for SIL204, which demonstrated effective biodistribution and anti-tumor activity against pancreatic cancer metastasis.
Future Plans: The company plans to initiate Phase 2/3 clinical trials for SIL204 in early 2026, with regulatory submissions expected in late 2025 and early 2026, while analysts maintain a Moderate Buy rating with a target price suggesting a potential 436.12% upside.
Silexion Therapeutics Shares Encouraging Preclinical Findings on SIL204's Effectiveness and Distribution in Key Metastatic Sites of Pancreatic Cancer After Systemic Delivery
New Preclinical Data: Silexion Therapeutics announced successful preclinical results showing that their drug SIL204 effectively targets primary and metastatic sites of pancreatic cancer, achieving measurable reductions in tumor burden in a mouse model.
Dual-Route Administration Strategy: The findings support Silexion's dual-route administration approach, combining subcutaneous delivery for metastatic disease with intratumoral delivery for primary tumors, with plans to initiate Phase 2/3 clinical trials in H1 2026.
Silexion Finishes Toxicology Studies for SIL204; Phase 2/3 Trial for Pancreatic Cancer Set to Start in Q2
SIL204 Development: Silexion Therapeutics has completed toxicology studies for SIL204, a next-generation siRNA therapy targeting mutated KRAS oncogenes in pancreatic cancer, showing no systemic organ toxicity.
Therapeutic Potential: SIL204 has demonstrated significant inhibition of cancer cell growth in preclinical models and positive anti-tumor activity in pancreatic cancer, paving the way for regulatory submissions in Israel and Germany.
Clinical Trial Plans: The therapy is set to progress to a Phase 2/3 trial in Q2 2026, utilizing a unique regimen that combines intratumoral and systemic administration to evaluate safety and efficacy in patients with locally advanced pancreatic cancer.
Stock Performance: Silexion's stock has fluctuated between $2.13 and $63.45 over the past year, closing at $2.44, reflecting a 13.48% increase in recent trading.
Silexion Completes Toxicology Studies for SIL204, Plans Phase 2/3 Trial in 2026
- Successful Toxicology Studies: Silexion has completed dual-species toxicology studies for SIL204, confirming no systemic organ toxicity, which lays the groundwork for planned regulatory submissions in Israel and Germany, potentially accelerating clinical trial progress.
- Clinical Trial Timeline: The company is on track to initiate a Phase 2/3 clinical trial for locally advanced pancreatic cancer in Q2 2026, ensuring competitiveness and timely market entry in the oncology sector.
- Innovative Therapy Potential: SIL204, designed as a next-generation RNA interference therapy targeting mutant KRAS oncogenes, has demonstrated significant anti-tumor activity in vitro, indicating its substantial potential in treating aggressive cancers.
- Integrated Treatment Strategy: The company's approach combines both intratumoral and systemic administration, aiming to improve survival rates for patients suffering from high-mortality cancers that currently lack effective treatment options.
Silexion Therapeutics Meets Nasdaq Listing Standards Again
Regaining Compliance: Silexion Therapeutics has regained compliance with Nasdaq listing rules regarding minimum bid price and shareholders' equity, confirming a minimum bid price of $1.00 per share and $2.5 million in shareholders' equity.
Clinical Development Focus: The company is advancing towards Phase 2/3 clinical trials for its RNAi therapy SIL204, which has shown promising preclinical results in inhibiting KRAS-driven cancers, and is committed to developing innovative treatments for solid tumor cancers.
Silexion Therapeutics Stock Rises Following Encouraging Preclinical Results for Pancreatic Cancer
Stock Performance: Silexion Therapeutics Corp. (SLXN) stock rose 14.83% to $5.15 on Thursday, with a trading volume significantly higher than its average, following the release of promising preclinical data.
Preclinical Study Findings: New data shows that SIL204 effectively targets pancreatic cancer metastasis, demonstrating anti-tumor activity and significant reductions in tumor burden across multiple organs in a mouse model, supporting its potential for clinical trials.
What’s Behind the 190% Surge in Silexion Therapeutics Stock (SLXN) Today?
Stock Performance: Silexion Therapeutics (SLXN) stock surged 188.07% in pre-market trading after positive pre-clinical data for SIL204, which demonstrated effective biodistribution and anti-tumor activity against pancreatic cancer metastasis.
Future Plans: The company plans to initiate Phase 2/3 clinical trials for SIL204 in early 2026, with regulatory submissions expected in late 2025 and early 2026, while analysts maintain a Moderate Buy rating with a target price suggesting a potential 436.12% upside.
Silexion Therapeutics Shares Encouraging Preclinical Findings on SIL204's Effectiveness and Distribution in Key Metastatic Sites of Pancreatic Cancer After Systemic Delivery
New Preclinical Data: Silexion Therapeutics announced successful preclinical results showing that their drug SIL204 effectively targets primary and metastatic sites of pancreatic cancer, achieving measurable reductions in tumor burden in a mouse model.
Dual-Route Administration Strategy: The findings support Silexion's dual-route administration approach, combining subcutaneous delivery for metastatic disease with intratumoral delivery for primary tumors, with plans to initiate Phase 2/3 clinical trials in H1 2026.
