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Can-Fite BioPharma Ltd. reports developments for a clinical-stage biotechnology pipeline of proprietary small-molecule drugs targeting the A3 adenosine receptor (A3AR). Recurring news covers Namodenoson and Piclidenoson across oncology, inflammatory disease, liver disorders, metabolic disease, obesity-related uses, and companion-animal osteoarthritis through its veterinary commercialization relationship.
Company updates also include clinical and regulatory disclosures, patent allowances in multiple jurisdictions, operating and financial results, material agreements, capital-structure actions, and governance matters tied to its American Depositary Shares and ordinary-share voting processes.
Can-Fite (NYSE American: CANF) reported new preclinical data showing its drug candidate namodenoson enhanced the anti-cancer effect of gemcitabine in pancreatic cancer models by increasing cleaved caspase-3, a key apoptosis protein. According to Can-Fite, these mechanistic findings support the design of its planned randomized Phase IIb study in advanced pancreatic adenocarcinoma, which will test namodenoson combined with gemcitabine and Nab-paclitaxel. The company noted this approach builds on a favorable safety profile and encouraging clinical activity from its prior Phase IIa monotherapy study, whose results have been accepted for presentation at the ESMO Congress 2026.
Can-Fite BioPharma (NYSE American: CANF) reported that its two lead oral A3 adenosine receptor agonists, Namodenoson and Piclidenoson, are advancing in Phase III programs under regulatory frameworks established with the FDA and EMA, defining pathways toward potential marketing approval.
Namodenoson is in a pivotal Phase III trial for advanced hepatocellular carcinoma with underlying Child-Pugh B7 cirrhosis, conducted under FDA and EMA guidance and intended to support potential marketing authorization applications if predefined efficacy and safety endpoints are met. Namodenoson also holds FDA Fast Track and orphan drug designations in both the United States and Europe. Piclidenoson is being evaluated in a Phase III program for moderate-to-severe plaque psoriasis. According to Can-Fite, the advanced regulatory status of both programs strengthens its late-stage clinical pipeline and provides a clear framework toward potential regulatory submissions and commercialization.
Can-Fite (NYSE American: CANF) submitted a Phase 2 clinical study protocol to Bambino Gesù Children's Hospital in Rome for the first clinical evaluation of Piclidenoson in patients with Lowe syndrome, a rare inherited OCRL-related disorder with severe renal, neurological, and ocular manifestations and no approved disease-modifying therapies.
The open-label, single-center Phase 2 trial will treat 5 adult patients with genetically confirmed Lowe syndrome with oral Piclidenoson twice daily for six months. The primary endpoint is improvement in renal uptake of 99mTc-DMSA as a measure of proximal tubular reabsorption, with secondary endpoints including urinary tubular biomarkers, Fanconi syndrome parameters, and safety. Piclidenoson entered clinical evaluation following preclinical data showing restoration of OCRL-dependent cellular function, and Can-Fite signed a collaboration agreement with Fondazione Telethon to develop Piclidenoson for this high unmet-need indication.
Can-Fite BioPharma (NYSE American/TASE: CANF) reported that an abstract with positive data from its Phase 2a study of oral Namodenoson in advanced pancreatic ductal adenocarcinoma has been accepted for poster presentation at the ESMO Congress 2026, a leading global oncology meeting.
The Phase 2a trial enrolled patients with advanced pancreatic cancer who had progressed after standard therapies, predominantly in the third-line setting. According to Can-Fite, the study met its primary safety endpoint and showed encouraging survival with durable disease stabilization; one patient treated in second line remains alive for more than 18 months.
Namodenoson is a highly selective A3 adenosine receptor agonist that induces cancer cell apoptosis and has shown anti-tumor activity in multiple preclinical models. The company is planning a Phase 2b study evaluating Namodenoson in combination with chemotherapy in pancreatic cancer, with further poster details to be provided later.
Can-Fite (NYSE American: CANF) announced that the Australian Patent Office has allowed Patent Application No. 2021290439, entitled “Treatment of Advanced Metastatic Cancer,” supporting the development and future marketing of its drug candidate Namodenoson in liver and pancreatic cancers.
Namodenoson is in a pivotal Phase 3 study for advanced hepatocellular carcinoma, following FDA and EMA protocol agreement. According to Can-Fite, a Phase 2a pancreatic cancer study showed an excellent safety profile, encouraging survival and durable disease stabilization, with a Phase 2b trial planned in combination with gemcitabine. The drug selectively targets the A3 adenosine receptor to induce tumor cell apoptosis while sparing normal tissue.
Can-Fite (NYSE American: CANF) completed enrolment of 247 patients for the interim analysis in its pivotal Phase 3 trial of Piclidenoson for moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled study will assess efficacy and safety, with interim data expected in Q4 2026/Q1 2027.
Piclidenoson is an oral A3 adenosine receptor agonist given as 3 mg tablets twice daily, with co-primary endpoints PASI 75 and sPGA 0/1 at Week 16 and a favourable safety profile reported in over 1,500 treated subjects.
Can-Fite (NYSE American: CANF) reported Phase 2a results for Namodenoson in advanced pancreatic ductal adenocarcinoma. The 20‑patient, open-label study met its primary safety endpoint, with Namodenoson well tolerated.
In eight evaluable third-line patients, median overall survival exceeded five months, with durable disease control and two patients still alive. One second-line patient remains alive beyond 18 months. Can-Fite plans a Phase 2b combination study with chemotherapy, supported by preclinical data showing Namodenoson enhances chemotherapeutic anti-tumor activity.
Can-Fite (NYSE American: CANF) received a Japanese patent allowance for Namodenoson's anti-obesity technology, covering A3 adenosine receptor agonists for fat loss, obesity, and related metabolic disorders.
The patent expands global IP protection alongside the US, Canada, Australia, and Israel, supporting partnering potential in an obesity therapeutics market forecast above $60 billion by 2030.
Can-Fite (NYSE American: CANF) announced a peer-reviewed Biomolecules Journal article highlighting the broad therapeutic potential of its A3 adenosine receptor agonists Piclidenoson and Namodenoson across oncology, inflammatory, metabolic, neurodegenerative, musculoskeletal and rare genetic diseases.
Namodenoson and Piclidenoson are in Phase 2–3 trials, supporting Can-Fite’s A3AR platform strategy.
Can-Fite (NYSE American: CANF) will present its late-stage clinical pipeline and licensing opportunities at the BIO International Convention 2026, held June 22–25 in San Diego.
The company plans partnering meetings focused on oncology, liver disease, inflammatory disease, and regional licensing for Namodenoson and Piclidenoson.