Silexion Therapeutics Corp Stock Price, News & Analysis

Silexion Therapeutics (NASDAQ: SLXN) reported 2025 preclinical and operational progress for its lead RNAi asset SIL204, including >90% tumor inhibition in multiple human KRAS-mutant models and validated activity against 8 KRAS mutations. The company completed two‑species toxicology with no systemic organ toxicity reported, received positive written scientific advice from Germany’s BfArM, raised >$18 million, regained Nasdaq compliance, and established manufacturing and CRO partnerships. Silexion plans a Phase 2/3 LAPC trial with regulatory submissions and clinical start targeted in H1 2026 (Q1 regulatory responses expected).

Silexion Therapeutics (NASDAQ:SLXN) submitted a Phase 2/3 clinical trial application in Israel for SIL204 in locally advanced pancreatic cancer, targeting a trial start in Q2 2026. The filing follows positive Scientific Advice from the German regulator (BfArM), two species toxicology studies showing no systemic organ toxicity, and preclinical data reporting up to 99.7% cancer cell inhibition across multiple KRAS mutations. Silexion plans additional regulatory submissions in Germany and the EU in Q1 2026, with U.S. site expansion expected after completion of the safety run-in. The Israeli portion is being prepared in collaboration with Sheba Medical Center, subject to approvals.

Silexion Therapeutics (NASDAQ: SLXN) received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) on the proposed design of its planned Phase 2/3 trial for SIL204 in locally advanced pancreatic cancer.

The feedback confirmed acceptability of core elements—clinical design, dosing, patient population, nonclinical support, and CMC/manufacturing—and will be incorporated into regulatory submissions in Israel by end-Q4 2025 and in Germany in Q1 2026. The company remains on track to initiate the Phase 2/3 trial in H1 2026, pending regulatory clearance.

Silexion Therapeutics (NASDAQ:SLXN) said company management will present at Noble Capital Markets' 21st Annual Emerging Growth Equity Conference on December 3, 2025 from 2:30–2:55pm ET at Florida Atlantic University Conference Center, Boca Raton, FL (Presentation Room 5).

Speakers include Ilan Hadar, CEO and Mirit Horenshtein-Hadar, CFO. Management will be available for one-on-one meetings by arrangement. A replay will be posted to Silexion's investor relations Events & Presentations page after the conference.

Silexion Therapeutics (NASDAQ: SLXN) completed two‑species toxicology studies for SIL204, its next‑generation siRNA therapy targeting mutated KRAS, which showed no systemic organ toxicity. The company said these results support planned regulatory submissions to Israel and Germany and keep Silexion on track to start a Phase 2/3 trial in locally advanced pancreatic cancer in Q2 2026. Preclinical data cited include broad in vitro KRAS mutant cell‑line growth inhibition and systemic anti‑tumor activity in pancreatic sites. Management noted a secured CRO partner and an integrated intratumoral plus systemic dosing approach as next steps toward clinical development.

Silexion Therapeutics (NASDAQ: SLXN) reported Q3 2025 results and a business update on Nov 12, 2025. The company raised approximately $9.5 million in Q3, increasing cash to $9.2 million as of Sept 30, 2025, and shareholders' equity to $7.0 million. Silexion selected AMS Advanced Medical Services as CRO and remains on track to file regulatory submissions in Israel in Q4 2025 and in Germany/EU in Q1 2026, targeting Phase 2/3 initiation in H1 2026. New preclinical data show SIL204 killed cancer cells across five KRAS-driven cancer types and eight mutations, including first evidence in gastric cancer. Nasdaq listing compliance was regained on Sept 23, 2025.

Silexion Therapeutics (NASDAQ:SLXN) has announced breakthrough preclinical data for its pan-KRAS inhibitor SIL204, demonstrating exceptional efficacy across multiple cancer types. The drug achieved 83.5% to 99.7% inhibition in eleven human cell lines across 5 different organ cancer sites.

Key highlights include the first evidence of gastric cancer activity, with 89.2% inhibition in the SNU-601 cell line, and remarkable efficacy in lung cancer cells showing up to 99.7% inhibition. The drug demonstrated activity against eight KRAS mutations (G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D) at nanomolar concentrations.

Silexion plans to advance SIL204 to Phase 2/3 clinical trials in H1 2026, with regulatory submissions scheduled for Q4 2025 in Israel and Q1 2026 in the EU.

Silexion Therapeutics (NASDAQ: SLXN), a clinical-stage biotech company developing RNAi therapies for KRAS-driven cancers, has regained compliance with Nasdaq's listing requirements. The company has met both the minimum bid price requirement of $1.00 per share and the minimum shareholders' equity requirement of $2.5 million.

The company is preparing for Phase 2/3 clinical trials of its SIL204 therapy, scheduled for the first half of 2026. Recent preclinical data showed promising results with up to 97% inhibition rates across multiple KRAS-driven cancer types. Silexion has also established a strategic CRO collaboration to advance its clinical development strategy.

Silexion Therapeutics (NASDAQ: SLXN), a clinical-stage biotech focused on RNA interference therapies for KRAS-driven cancers, has announced the pricing of a $6.0 million public offering. The offering includes 1,500,000 ordinary shares (or equivalents) with accompanying series A and B warrants at $4.00 per share.

The offering includes series A warrants with a 5-year term and series B warrants with a 12-month term, both with a $4.00 exercise price. H.C. Wainwright & Co. is serving as the exclusive placement agent. The proceeds will support pre-clinical studies and general corporate purposes, with closing expected around September 12, 2025.