On August 12, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported an update on the regulatory status of its two lead drug candidates, Piclidenoson and Namodenoson. Both drug candidates are being advanced in Phase III clinical development programs under regulatory frameworks established with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing defined regulatory pathways toward potential marketing approval.
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Namodenoson, Can-Fite’s orally administered A3 adenosine receptor (A3AR) agonist, is currently being evaluated in a pivotal Phase III study for the treatment of patients with advanced liver cancer, hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 liver cirrhosis. The Phase III study is being conducted under regulatory guidance from both the FDA and EMA and is designed to support potential marketing authorization applications in the United States and Europe, if the study meets its predefined efficacy and safety endpoints.
Piclidenoson, Can-Fite’s oral A3AR agonist for inflammatory diseases, is currently being evaluated in a Phase III clinical program for the treatment of moderate-to-severe plaque psoriasis.
Can-Fite’s clinical development strategy is focused on advancing its lead drug candidates through late-stage clinical development under regulatory pathways established with leading regulatory authorities.
Namodenoson’s FDA Fast Track and FDA and EMA Orphan Drug designations provide additional regulatory advantages as the Company advances its pivotal HCC program, while Piclidenoson is progressing through Phase III development in psoriasis.
Can-Fite believes that the advanced regulatory status of both programs significantly strengthens the Company’s late-stage clinical pipeline and provides a clear framework for advancing Piclidenoson and Namodenoson toward potential regulatory submissions and commercialization.
"Can-Fite has reached an important stage in its development, with both of our lead drug candidates in Phase III programs and with established regulatory pathways in the United States and Europe," stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairperson. "Namodenoson’s Fast Track and Orphan Drug designations, together with our ongoing pivotal Phase III HCC study, and the Phase III development of Piclidenoson in psoriasis, demonstrate the maturity of our clinical pipeline. We believe these regulatory achievements provide greater clarity regarding the development and potential approval pathways for our drug candidates and bring us closer to our goal of delivering new oral therapies to patients with significant unmet medical needs."
(Press release, Can-Fite BioPharma, AUG 12, 2026, View Source [SID1234670003])