Biotech Stock Silexion Therapeutics Corp. (NASDAQ: SLXN) Soars on Update and First Quarter Results

The stock makes the Nasdaq top percentage gainers list on news, currently trading at 0.4629+0.1939 (+72.08%) on volume of over 300 Million shares as of this report.

Silexion Therapeutics provided an update on recent business developments following the release of its financial results for the first quarter ended March 31, 2026, which were reported on May 15, 2026.

Recent Milestones & Business Highlights

• Israeli Ministry of Health Approval to Initiate Phase 2/3 Clinical Trial of SIL204

  On March 24, 2026, Silexion announced that it had received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating the Company's lead product candidate SIL204 for the treatment of locally advanced pancreatic cancer. The approval represented a defining regulatory milestone for the Company, marking the transition of SIL204 into clinical-stage development of a next-generation siRNA therapy designed to silence mutated KRAS - a driver present in approximately 90% of pancreatic cancers - and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers. The approval followed strong positive anti-tumor activity demonstrated across multiple preclinical models, successful completion of two-species toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design.

• Phase 2/3 Clinical Trial Application Submitted to Germany

  On April 28, 2026, subsequent to quarter end, the Company announced the successful submission of a Clinical Trial Application (CTA) to Germany for the planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer. The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State leading the scientific assessment of the trial across the European Union. The submission was informed by the positive written Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices (BfArM) in December 2025, and was supported by the Company's comprehensive regulatory and preclinical package, including completed two-species toxicology studies.

• Phase 2/3 Trial Initiation Planned for the Second Quarter of 2026

  The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer using Silexion's dual-route administration approach - combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The Company plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with previously announced Israeli sites led by Sheba Medical Center.

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The first quarter and the period since represented a defining moment in Silexion's evolution. With the Israeli Ministry of Health approval to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, and our subsequent submission of a Clinical Trial Application to Germany under the EU Clinical Trials Regulation, we have advanced SIL204 from a preclinical asset into clinical-stage development across two major regulatory jurisdictions. We remain on track to initiate the Phase 2/3 clinical trial in the second quarter of 2026, with the goal of bringing an RNAi-based approach to patients with KRAS-driven cancers who have limited treatment options today."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the first quarter and subsequent to quarter end, we executed a series of capital-raising and corporate actions designed to support our clinical development plan and our continued Nasdaq listing. These included our May 2026 warrant exercise inducement transaction, additional capital raised under our at-the-market facility, and obtaining shareholder approval for a prospective reverse share split. We continue to evaluate financing alternatives as we work to support the advancement of SIL204 into the clinic in the second quarter of 2026."

Full news release

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