Can-Fite recaps FDA, EMA regulatory status for two Phase III drugs

Can-Fite BioPharma Ltd. issued a press release on August 12, 2026 summarizing the regulatory status of its two lead drug candidates, Piclidenoson and Namodenoson.¹ Both candidates are being advanced in Phase III programs under frameworks established with the FDA and EMA, which the company said provides defined regulatory pathways toward potential marketing approval.¹

Namodenoson is an oral A3 adenosine receptor agonist. It is currently in a pivotal Phase III study for advanced liver cancer, hepatocellular carcinoma, in patients with underlying Child-Pugh B7 liver cirrhosis.¹ That study operates under guidance from both the FDA and EMA and is designed to support marketing authorization applications in the US and Europe if it meets its predefined efficacy and safety endpoints.¹

Piclidenoson is Can-Fite's other oral A3AR agonist, developed for inflammatory disease. It is currently being evaluated in a Phase III program for moderate-to-severe plaque psoriasis.¹

Namodenoson carries FDA Fast Track designation along with FDA and EMA Orphan Drug designations as the company advances its pivotal HCC program.¹ Company chairperson Dr. Pnina Fishman said the company has reached an important stage in its development, with both lead candidates in Phase III programs and established regulatory pathways in the US and Europe.¹

Separately, the release noted broader pipeline detail: Piclidenoson recently reported topline results in a Phase 3 psoriasis trial and started a pivotal Phase 3 trial, while Namodenoson is also being evaluated in a Phase 2b trial for MASH and a Phase 2a study in pancreatic cancer.¹ The company's third candidate, CF602, has shown efficacy in erectile dysfunction, and the three drugs together have been studied in over 1,600 patients to date.¹