Can-Fite’s Namodenoson Successfully Meets Primary Endpoint in Phase 2a Pancreatic Cancer Study
Rhea-AI Summary
Can-Fite (NYSE American: CANF) reported that its Phase 2a open-label study of namodenoson in advanced pancreatic ductal adenocarcinoma met its primary endpoint of safety. The trial enrolled 20 heavily pretreated patients; namodenoson was very well tolerated with no new safety signals identified.
Survival follow-up is ongoing; one-third of patients were alive at data cut-off. Namodenoson holds FDA Orphan Drug Designation for pancreatic cancer and remains under further clinical evaluation.
Positive
- Primary safety endpoint met in Phase 2a PDAC study
- No new safety signals identified in heavily pretreated patients
- FDA Orphan Drug Designation for pancreatic cancer
Negative
- Small sample size of 20 patients limits statistical conclusions
- Survival data immature; only 1/3 of patients alive at cut-off
News Market Reaction – CANF
On the day this news was published, CANF gained 20.40%, reflecting a significant positive market reaction. Argus tracked a peak move of +98.1% during that session. Our momentum scanner triggered 40 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $7M at that time. Trading volume was exceptionally heavy at 21.6x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CANF is up 2.88% while close biotech peers show mixed moves (e.g., ADAP -17.57%, BIVI +6.2%, CYCC -5.84%). Only one peer (BCTX -1.0%) appears in the momentum scanner, supporting a stock-specific move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jul 30 | Pancreatic trial enrollment | Positive | -5.3% | Reported Phase 2a pancreatic trial passing 50% enrollment with favorable safety. |
| May 05 | Funding & Phase 3 | Positive | +2.2% | Announced $175M total funding to advance namodenoson and piclidenoson into pivotal Phase 3. |
| Mar 20 | Canine OA trial | Positive | -7.3% | Partner launched advanced clinical study of piclidenoson for canine osteoarthritis in large market. |
| Mar 19 | Lowe Syndrome study | Positive | -19.4% | Announced Phase II study design of piclidenoson in rare Lowe Syndrome with 12‑month treatment. |
| Nov 11 | First patient dosed | Positive | -0.5% | Reported first patient dosing in pancreatic Phase IIa namodenoson trial focused on safety and survival. |
Clinical and trial-related headlines have more often been followed by negative next-day moves, with only one positive reaction among the five same-tag events.
Over the past year, CANF’s clinical pipeline has advanced through several milestones. For pancreatic cancer, namodenoson moved from first patient dosing on Nov 11, 2024 to over 50% enrollment by Jul 30, 2025. Broader clinical activity included funding to advance pivotal Phase 3 trials and new programs such as osteoarthritis and Lowe Syndrome. Despite generally positive clinical updates, same-tag news often saw muted or negative next-day price reactions.
Historical Comparison
Across recent clinical-trial headlines, CANF’s average next-day move was -6.03%. A positive reaction of 2.88% to this pancreatic safety readout would contrast with that typically negative pattern.
For pancreatic cancer, namodenoson advanced from first patient dosing to over 50% enrollment and then full enrollment, culminating in this Phase 2a readout confirming the primary safety endpoint.
Market Pulse Summary
The stock surged +20.4% in the session following this news. A strong positive reaction aligns with the clearly favorable safety outcome in a high‑risk pancreatic cancer population but would differ from CANF’s average -6.03% move on prior clinical headlines. Investors monitoring such a surge might weigh the historically weak follow‑through after trial news against the significance of confirming safety in this indication and the stock’s longer-term downtrend below its 200-day MA.
Key Terms
pancreatic ductal adenocarcinoma medical
overall survival medical
progression-free survival medical
a3 adenosine receptor medical
orphan drug designation regulatory
AI-generated analysis. Not financial advice.
Ramat Gan, Israel, March 04, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced results from its Phase IIa open-label study evaluating namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who had progressed following prior systemic therapies.
The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.
The study enrolled 20 patients with advanced PDAC who had received one or more prior lines of therapy. Patients represented a high-risk population, including individuals with varying performance status and advanced metastatic disease.
Secondary endpoints included overall survival (OS) and progression-free survival (PFS). Survival follow-up remains ongoing, with 1/3 of patients currently alive at the time of data cut-off. As follow-up continues, survival outcomes are expected to further mature and will be announced during upcoming scientific meetings.
“The favorable safety profile observed in this difficult-to-treat population supports continued clinical evaluation of namodenoson,” Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel. “We are continuing to monitor survival outcomes as data mature.”
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, timing of efficacy data and prospects for generating meaningful efficacy data . All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. For example, the Company is using forward-looking statements when it discusses the completion of the offerings, the satisfaction of customary closing conditions related to the offerings and the intended use of proceeds therefrom. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on April 14, 2025 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Contact
Can-Fite BioPharma
Motti Farbstein
+972-3-9241114
FAQ
What did Can-Fite (CANF) announce about the Phase 2a namodenoson study on March 4, 2026?
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