Welcome to our dedicated page for Silexion Therapeutics news (Ticker: SLXN), a resource for investors and traders seeking the latest updates and insights on Silexion Therapeutics stock.
Silexion Therapeutics Corp (NASDAQ: SLXN) is a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, with a lead focus on locally advanced pancreatic cancer. The news flow around Silexion centers on its progress with SIL204, a next-generation siRNA therapy designed to silence mutated KRAS oncogenes that drive aggressive solid tumors.
Readers following SLXN news can expect updates on preclinical data, regulatory milestones, and clinical trial preparations. Recent press releases have highlighted new human cancer cell line results demonstrating high inhibition across multiple KRAS mutations and organ sites, including pancreatic, colorectal, lung, and gastric cancer models. The company has also reported biodistribution and efficacy data in metastatic pancreatic cancer models, as well as completion of two-species toxicology studies that it states confirmed no systemic organ toxicity.
Another key theme in Silexion’s news is its regulatory and clinical development pathway for SIL204. The company has announced formal written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) on the design of its planned Phase 2/3 trial in locally advanced pancreatic cancer, submission of a clinical trial application in Israel, and plans for additional submissions in Europe and the United States. Operational updates include selection of a contract research organization, manufacturing collaborations, and preparations for trial initiation.
In addition, Silexion’s news releases cover financing transactions, capital-raising activities, and Nasdaq listing matters, such as regaining compliance with minimum bid price and shareholders’ equity requirements. Investors and observers can use this news page to review company communications on scientific results, regulatory interactions, business developments, and conference presentations related to Silexion’s KRAS-focused RNAi oncology programs.
Silexion Therapeutics (NASDAQ: SLXN) reported new positive preclinical data showing that its KRAS-targeting siRNA SIL204 exerts multi-mechanism immune sensitization in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines. SIL204 significantly upregulated the FAS (CD95) immune death receptor and downregulated HLA-G, an immune checkpoint, across KRAS G12D, G12V and G12C models.
Combined with previously reported MHC-I (HLA-ABC) upregulation in KRAS G12R-mutant pancreatic cells, the data support a coordinated signature involving increased antigen presentation, restored susceptibility to immune-mediated apoptosis, and reduced immune checkpoint activity across four KRAS mutations. According to Silexion, these findings reinforce the rationale for combining SIL204 with anti-PD-(L)1 therapies and provide additional translational support as SIL204 advances into Phase 2/3 clinical evaluation, following initiation of the first trial site at Tel Aviv Sourasky Medical Center in July 2026.
Silexion Therapeutics (NASDAQ: SLXN) has initiated its Phase 2/3 clinical trial of SIL204, its lead siRNA candidate, at Tel Aviv Sourasky Medical Center, formally activating the first site for patients with locally advanced pancreatic cancer. The site is now cleared to begin patient screening, with first dosing expected in the coming weeks.
According to Silexion, this milestone follows a rapid sequence of approvals and preparations in Israel and Germany, including Israeli Ministry of Health and BfArM authorizations, institutional ethics clearance, and GMP clinical supply manufacturing. The trial will start with a safety run-in of about 18 patients, then expand globally to a randomized cohort of roughly 166 patients, testing SIL204 plus standard chemotherapy via dual intratumoral and systemic administration.
Silexion Therapeutics (NASDAQ: SLXN) received unconditional approval from Germany's BfArM, with a positive ethics opinion, to start a Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer. Alongside prior Israeli authorization, this clears initiation across both countries, with first patient dosing expected in the coming weeks.
The study will test SIL204 plus standard chemotherapy using dual intratumoral and systemic administration, beginning with ~18-patient safety run-in, then ~166-patient randomized expansion, and may later expand to additional EU states under the CTIS framework.
Silexion Therapeutics (NASDAQ:SLXN), a clinical-stage biotech developing RNAi therapies for KRAS-driven cancers, will attend the 2026 BIO International Convention in San Diego, CA from June 22–25, 2026.
Company leadership will host one-on-one investor and partner meetings during the convention.
Silexion Therapeutics (NASDAQ: SLXN) approved a 1-for-10 reverse share split of its ordinary shares. The split becomes effective after market close on May 28, 2026, with trading on a split-adjusted basis starting May 29, 2026 under ticker SLXN.
The action aims to maintain compliance with Nasdaq’s minimum bid price requirement, reinforce Silexion’s capital structure, and support strategic growth and potential equity financings as it prepares to initiate a Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer.
Silexion Therapeutics (NASDAQ: SLXN) reported first quarter 2026 results and a business update focused on SIL204 for locally advanced pancreatic cancer.
Key points include Israeli approval and a German CTA for the Phase 2/3 SIL204 trial, higher R&D spending, a larger net loss, lower cash, and post‑quarter capital raises that, according to Silexion, lifted shareholders’ equity above the $2.5 million Nasdaq Capital Market minimum.
Silexion Therapeutics (NASDAQ: SLXN) entered definitive agreements for the immediate cash exercise of certain outstanding warrants to purchase up to 1,995,092 ordinary shares at $0.50 per share, for expected gross proceeds of about $1 million before fees.
The company plans to use net proceeds as working capital for general corporate purposes. In connection, Silexion will issue new unregistered Series C warrants for up to 2,045,000 shares and Series D warrants for up to 1,945,184 shares, each with a $0.50 exercise price and expirations of five years and twenty-four months, respectively, after specified shareholder approval and resale registration milestones.
Silexion Therapeutics (NASDAQ: SLXN) reported positive preclinical immuno-oncology data for its RNAi candidate SIL204 in KRAS-driven cancers.
In human KRAS G12R-mutated pancreatic cancer cells, SIL204 produced a statistically significant increase in surface MHC-I (HLA-ABC) expression, and similar effects were seen in KRAS-mutated non-small cell lung cancer cells, supporting potential future evaluation with anti-PD-1 therapies such as pembrolizumab (Keytruda).
Silexion Therapeutics (NASDAQ: SLXN) announced initiation of GMP clinical batch manufacturing of SIL204 with Catalent in Limoges, France, to supply its planned Phase 2/3 trial in locally advanced pancreatic cancer.
Tel Aviv Sourasky Medical Center’s Helsinki Ethics Committee also approved the Phase 2/3 trial, following prior Israeli Ministry of Health authorization and a Clinical Trial Application submission in Germany.
Silexion Therapeutics (NASDAQ: SLXN) submitted a Clinical Trial Application to Germany's BfArM via EU CTIS for a planned Phase 2/3 trial of SIL204 in KRAS-driven locally advanced pancreatic cancer. The filing follows positive BfArM scientific advice and Israeli Ministry of Health approval, and supports planned trial initiation in Q2 2026 across Germany, other EU states, and Israel.
The trial will test SIL204 with standard chemotherapy using a dual-route intratumoral plus systemic administration strategy, starting with a safety run-in then a randomized cohort.