Can-Fite BioPharma (CANF) Soars on 9-Year Liver Cancer Survival Breakthrough with Namodenoson

Small-cap Israeli biotech rallies after reporting a decade-long cancer‑free outcome in advanced hepatocellular carcinoma and launching enrollment in a pivotal Phase III trial.

Shares of Can-Fite BioPharma Ltd. (NYSE American: CANF, TASE: CANF) jumped on Tuesday after the company reported a striking 9‑year overall survival with a complete response in an advanced liver cancer patient treated with its investigational drug Namodenoson, and confirmed that a pivotal Phase III trial in hepatocellular carcinoma (HCC) is now enrolling patients in multiple regions. ^[1]

According to real‑time market data, Can-Fite’s American Depositary Receipts (ADRs) traded around $0.47 on November 18, up more than 30% from the prior close near $0.36, with intraday prices ranging roughly between $0.45 and $0.62 as traders reacted to the news. ^[2] TipRanks separately reported that CANF was up over 50% in pre‑market trading, accompanied by unusually heavy volume. ^[3]

Today’s Can-Fite (CANF) Headlines at a Glance – November 18, 2025

All major news about Can-Fite BioPharma today centers on Namodenoson and its liver cancer program:

GlobeNewswire / Company press release:
Can-Fite announces a patient with advanced hepatocellular carcinoma has reached 9 years of overall survival with a complete response on Namodenoson; the patient remains cancer‑free and continues treatment via a compassionate use program. ^[4]
Pivotal Phase III HCC trial enrolling:
The company confirms ongoing enrollment in a pivotal Phase III trial of Namodenoson for 2nd/3rd line advanced HCC in Israel, Europe, and the U.S., under a protocol agreed with both the U.S. FDA and EMA. ^[5]
Regulatory designations:
Namodenoson carries Orphan Drug status from both FDA and EMA and Fast Track designation from the FDA for HCC, positioning it within a high‑need oncology niche. ^[6]
SEC Form 6‑K filing:
Can-Fite files a Form 6‑K with the U.S. Securities and Exchange Commission, formally furnishing today’s press release and incorporating its first paragraph by reference into several existing Form S‑8 and Form F‑3 registration statements. ^[7]
Third‑party coverage & AI summaries:
TipRanks and other financial news platforms publish auto‑generated and analyst‑oriented coverage emphasizing the 9‑year survival milestone, Phase III enrollment, and mixed sentiment on the stock. ^[8]

9-Year Cancer‑Free Survival in an Advanced Liver Cancer Patient

In its early‑morning press release, Can-Fite disclosed that a patient with advanced hepatocellular carcinoma who participated in a prior Phase II trial of Namodenoson has now achieved 9 years of overall survival and remains cancer‑free. ^[9]

Key clinical details from the company:

The patient initially enrolled in a completed Phase II study of Namodenoson for advanced HCC. ^[10]
Following trial participation, treatment continued under a compassionate use program, which the company notes is ongoing in Israel and Romania. ^[11]
Nine years later, the patient reportedly meets the definition of a “complete responder”, with:
- disappearance of ascites,
- normal liver function, and
- an overall good quality of life. ^[12]

Independent AI‑driven summaries from platforms like Quiver and StockTitan echo this framing, stressing that while the result is clinically remarkable, it is still single‑patient, and therefore not yet proof of broad efficacy in the wider HCC population. ^[13]

Pivotal Phase III Trial: From Case Study to Clinical Proof

Alongside the long‑term survival case, Can-Fite underscored that it is now enrolling patients into a pivotal Phase III trial evaluating Namodenoson as 2nd or 3rd line therapy for advanced HCC. ^[14]

According to the company:

The study protocol has been agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). ^[15]
Enrollment is ongoing in Israel, Europe, and the U.S., targeting patients with advanced HCC who have already received at least one prior systemic treatment. ^[16]
Namodenoson’s regulatory status includes:
- Orphan Drug designation in both the U.S. and EU, and
- Fast Track designation from the FDA as a second‑line treatment for HCC. ^[17]

The company and third‑party analyses emphasize that this Phase III trial, not the individual case report, will be the decisive test of whether the impressive single-patient outcome can be reproduced at scale and translated into regulatory approvals. ^[18]

Namodenoson: A Targeted A3 Adenosine Receptor Agonist

Namodenoson is a small orally bioavailable small molecule that binds selectively and with high affinity to the A3 adenosine receptor (A3AR). ^[19]

Can-Fite highlights several features:

Selective targeting: A3AR is highly expressed in diseased cells (such as tumor and inflamed liver tissue) but shows low expression in normal cells, potentially explaining the favorable safety profile reported across studies to date. ^[20]
Multi‑indication program:
- Pivotal Phase III – advanced HCC (current focus of today’s news).
- Phase IIb – Metabolic dysfunction‑associated steatohepatitis (MASH).
- Phase IIa – Pancreatic cancer. ^[21]
Additional oncology opportunities: Proof-of‑concept data suggest potential activity in colon, prostate, and melanoma cancers, though these are at earlier stages of development. ^[22]

The 9‑year complete response in HCC, if borne out by broader data, could support the rationale that targeting A3AR provides durable anti‑tumor activity while sparing healthy liver tissue – a key challenge in cirrhotic or heavily pre‑treated patients. ^[23]

Liver Cancer Market Context: High Need, Growing Opportunity

Can-Fite’s announcement places Namodenoson squarely in a global market that remains highly underserved:

The American Cancer Society estimates that liver cancer accounts for more than 700,000 deaths worldwide each year, underscoring the aggressive nature of HCC and its generally poor survival outcomes. ^[24]
Market research cited by the company projects the HCC treatment market in G8 countries could reach around $6.1 billion by 2027, as new drugs and combination regimens expand treatment options. ^[25]

Against that backdrop, any therapy demonstrating meaningful survival improvements, particularly with an oral route and tolerable safety profile, could potentially capture significant share if supported by robust Phase III data.

CANF Stock: Micro‑Cap Biotech with High Volatility

Sharp Move Higher on Today’s News

Trading data from Investing.com and other platforms show CANF changing hands near $0.47 on November 18, up roughly 30% versus Monday’s close around $0.36, with intraday swings reaching as high as the low‑$0.60s. ^[26]

TipRanks reports: ^[27]

Pre‑market gains of about 51% today,
Trading volume above 146 million shares, far exceeding the three‑month average around ~258,000 shares, pointing to intense speculative interest.

StockTitan and other AI‑driven news dashboards list CANF among the top gainers for the day in the micro‑cap biotech universe. ^[28]

Valuation and Market Cap

Because CANF is a thinly traded micro‑cap, market cap estimates differ across data vendors:

StockTitan shows a market cap near $6.3 million around the latest close. ^[29]
TipRanks’ CANF overview cites a higher figure, around $15–16 million, reflecting potential differences in share count or timing of the quote. ^[30]

Despite the discrepancy, both sources underscore that Can-Fite remains a very small, high‑risk biotech, where even modest news flow can trigger outsized price moves.

SEC Form 6‑K: Press Release Formally Incorporated into Filings

In tandem with the clinical update, Can-Fite submitted a Form 6‑K to the U.S. SEC on November 18, 2025. ^[31]

Key points from the filing:

The first paragraph of today’s press release is incorporated by reference into several existing Form S‑8 and Form F‑3 shelf and employee compensation registration statements. ^[32]
This means the high‑level description of the company and its Namodenoson program now forms part of those registration documents as of today’s filing date. ^[33]
The form itself does not introduce new financial data; it is primarily a disclosure and cross‑referencing mechanism. ^[34]

For investors, the 6‑K confirms that the 9‑year survival case and the Phase III enrollment status are now part of the company’s formal U.S. disclosure record.

Analyst and AI Views: Mixed Sentiment Despite Positive Clinical Signal

The reaction from data and research platforms is nuanced:

Quiver Quantitative notes: ^[35]
- Two firms have issued Buy ratings on CANF in recent months, with a median price target around $6.75, implying large upside from current levels.
- Recent institutional activity includes both additions and reductions in positions, with some small hedge funds adding exposure in Q3 2025.
TipRanks auto‑generated news today describes the 9‑year survival as a “significant milestone”, but its AI‑driven “Spark” model currently tags CANF as “Underperform”, pointing to weak financials and bearish technical indicators. ^[36]
The same TipRanks piece also flags a recent Sell rating with a $0.50 price target, showing that at least one analyst remains cautious despite the clinical update. ^[37]

This blend of optimistic long‑term price targets and near‑term caution reflects a typical pattern in micro‑cap biotech: attractive theoretical upside if trials succeed, offset by high binary risk around clinical and financing milestones.

Where Namodenoson Fits in Can-Fite’s Broader Pipeline

While today’s spotlight is on Namodenoson in HCC, Can-Fite stresses that it is an advanced clinical‑stage company with multiple late‑stage programs: ^[38]

Piclidenoson
- Lead candidate in psoriasis, where a prior Phase III trial has reported topline results and the company has moved into a pivotal Phase III program.
Namodenoson
- Pivotal Phase III in advanced HCC (today’s news).
- Phase IIb in MASH.
- Phase IIa in pancreatic cancer.
CF602
- A third candidate with early‑stage data suggesting efficacy in erectile dysfunction.

Across these programs, Can-Fite claims exposure to multi‑billion‑dollar markets in cancer, liver disease, and inflammatory conditions, supported by clinical experience in more than 1,600 patients and an overall “excellent safety profile” for its A3AR‑targeted drugs. ^[39]

Key Risks and What to Watch Next

Even with today’s dramatic clinical anecdote and stock move, several important caveats and risks remain:

Single‑patient evidence:
Both the company’s own forward‑looking statements and independent AI summaries stress that the 9‑year complete response is based on one patient from a prior Phase II trial and a compassionate‑use setting. It is encouraging, but not yet generalizable to the wider HCC population. ^[40]
Pivotal data still years away:
Enrollment, endpoint selection, and follow‑up in the Phase III HCC trial will ultimately determine whether Namodenoson can deliver statistically robust survival gains. Investors will be watching for:
- enrollment pace,
- any interim analyses, and
- safety updates. ^[41]
Financing and dilution risk:
Can-Fite’s own risk disclosures highlight a history of operating losses and the need for additional capital to fund operations and clinical programs, with the possibility it may be difficult or costly to raise. ^[42]
Regulatory and geopolitical uncertainty:
Risks cited by the company include:
- uncertainties around regulatory approvals and timelines,
- potential impacts of renewed COVID‑19 disruptions,
- and the ongoing political and security situation in Israel, where the company is based. ^[43]
Listing and liquidity considerations:
The firm has previously flagged the risk of not meeting NYSE American continued listing requirements, and trading volumes can be extremely volatile, as seen today. ^[44]

Bottom Line

On November 18, 2025, Can-Fite BioPharma delivered one of the more eye‑catching biotech headlines of the day: a 9‑year cancer‑free survival in an advanced liver cancer patient on Namodenoson, paired with confirmation that a pivotal Phase III HCC trial is now enrolling in multiple regions under FDA/EMA‑agreed protocols. ^[45]

The market’s reaction has been swift, propelling CANF stock sharply higher on heavy volume and placing the micro‑cap name back on the radar of speculative biotech traders. Yet, today’s story is as much about promise as it is about proof: the key question is whether Namodenoson’s striking single‑patient outcome can be replicated in a larger, controlled Phase III setting—while the company secures sufficient funding and navigates regulatory and geopolitical challenges.

As with all small‑cap drug developers, Can-Fite remains a high‑risk, high‑volatility play, and today’s surge reflects expectations as much as evidence.

Disclosure: This article is for informational purposes only and does not constitute investment advice, a recommendation, or an offer to buy or sell any security.

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