Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer
Rhea-AI Summary
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.
Positive
- Received formal written Scientific Advice from BfArM
- Feedback confirmed acceptability of clinical design and dosing
- Guidance covered patient population, nonclinical support, and CMC
- Regulatory submissions planned: Israel by end-Q4 2025 and Germany Q1 2026
Negative
- Phase 2/3 initiation remains contingent on regulatory clearance in target jurisdictions
News Market Reaction
On the day this news was published, SLXN declined 7.61%, reflecting a notable negative market reaction. Argus tracked a trough of -17.6% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $740K from the company's valuation, bringing the market cap to $9M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
SLXN was down 1.31% while closely scored biotech peers were mixed: GLTO +2.55%, QLGN +7.72%, BDRX +9.57%, DRMA -4.18%, ENTO -5.68%. Only one peer (REVB, -5.05%) appeared on the momentum scanner, suggesting stock‑specific dynamics rather than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 02 | Clinical guidance | Positive | -7.6% | German BfArM endorses key elements of SIL204 Phase 2/3 trial design. |
| Nov 26 | Conference appearance | Positive | +20.4% | Management presenting at Noble Capital emerging growth equity conference. |
| Nov 25 | Toxicology results | Positive | +7.6% | Two‑species toxicology for SIL204 shows no systemic organ toxicity. |
| Nov 12 | Earnings & update | Positive | +3.6% | Q3 2025 results with added cash, CRO selection, and H1 2026 trial timeline. |
| Sep 30 | Preclinical data | Positive | +0.3% | Pan‑KRAS preclinical data show up to 99.7% inhibition across cancer cell lines. |
Over the last five news events, SLXN has typically traded higher on positive updates, with only the latest clinical‑trial guidance showing a negative price reaction despite constructive content.
Across recent announcements, Silexion has steadily advanced SIL204 toward a planned Phase 2/3 trial. Preclinical data showing up to 99.7% inhibition across KRAS‑driven cancers and successful toxicology studies supported regulatory submissions targeting H1 2026 trial initiation. The Q3 2025 update highlighted new financing, restored Nasdaq compliance, and expanded preclinical efficacy data. Today’s German BfArM feedback fits this trajectory by refining Phase 2/3 design and confirming key elements for upcoming submissions in Israel and Germany.
Regulatory & Risk Context
An active S‑3 resale registration filed Oct 31, 2025 covers up to 1,292,348 ordinary shares and 372 warrants. The company would only receive up to $4.9 million if 344,063 registered warrants are exercised for cash at the disclosed $3.44 per‑share conversion price. The filing also details potential dilution to as many as 3,945,414 shares outstanding if all registered warrants are exercised and the convertible note is fully converted.
Market Pulse Summary
The stock moved -7.6% in the session following this news. A negative reaction despite constructive BfArM guidance fits a divergence pattern occasionally seen when financing or dilution overhangs are in focus. SLXN carries an effective $100 million shelf and an ATM of $13.17 million, alongside ongoing losses of $7.5 million over nine months, which may tilt attention toward balance‑sheet risk. Historically, most positive SIL204 updates were followed by gains, so sustained weakness could reflect concern about future capital raises.
Key Terms
rna interference (rnai) medical
kras medical
bfarm regulatory
phase 2/3 medical
cmc technical
toxicology medical
AI-generated analysis. Not financial advice.
Positive feedback reinforces Silexion’s trajectory toward its planned Phase 2/3 trial initiation in Q2 2026
Company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026
GRAND CAYMAN, Cayman Islands, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) 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.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: “This written Scientific Advice represents a meaningful step in our regulatory path and provides us with the supporting clarity needed to finalize our Phase 2/3 submission packages. SIL204 continues to progress on schedule, and the engagement with BfArM supports the momentum we have built heading into 2026. We remain highly focused on bringing SIL204 into the clinic and advancing a therapy that we believe has the potential to address critical unmet needs in KRAS-mutated cancers.”
Silexion remains on track to initiate its Phase 2/3 clinical trial of SIL204 in the first half of 2026, pending regulatory clearance. The Company continues to advance all other operational and development activities required for trial launch, including manufacturing readiness, toxicology data integration, and clinical site preparations.
About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding Silexion’s business strategy, the regulatory guidance received from BfArM, the Company’s plans and expected timing for completing regulatory submissions in Israel and Germany, the anticipated initiation of the Phase 2/3 clinical trial for SIL204 in the second quarter of 2026, the advancement of operational and development activities required for trial launch, including manufacturing readiness, toxicology data integration, and clinical site preparations, and Silexion’s expectations regarding the future development of SIL204, are forward-looking statements. These forward-looking statements are generally identified by terminology such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them, or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion's ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Contact:
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
FAQ
What did Silexion announce about the Phase 2/3 trial design for SIL204 (SLXN) on December 2, 2025?
When will Silexion (SLXN) file regulatory submissions for SIL204 in Israel and Germany?
How does the BfArM feedback affect Silexion's (SLXN) trial timeline for SIL204?
What core areas did BfArM address in its Scientific Advice to Silexion (SLXN)?
Is SIL204 still on schedule after the BfArM feedback for Silexion (SLXN)?
