newsfilter
← Latest News
GlobeNewswire·

Can-Fite Highlights Advanced FDA and EMA Regulatory Status of its Phase III Drug Candidates

CANF
  • Can-Fite BioPharma received FDA Fast Track & U.S. & European Orphan Drug Designations for Namodenoson.
  • Both Namodenoson & Piclidenoson are advancing in Phase III clinical development programs under FDA & EMA frameworks.
  • Namodenoson is evaluated in a pivotal Phase III study for hepatocellular carcinoma (HCC) with underlying Child-Pugh B7 liver cirrhosis.
  • Piclidenoson is being evaluated in a Phase III program for moderate-to-severe plaque psoriasis.
  • Dr. Pnina Fishman stated the regulatory designations & Phase III status demonstrate pipeline maturity & clarify approval pathways.
  • Namodenoson also holds Orphan Drug Designations in the U.S. & Europe & Fast Track Designation as a second-line HCC treatment.
  • Additional Namodenoson trials include Phase 2b for MASH & Phase 2a for pancreatic cancer.
  • Can-Fite reports safety experience in over 1,600 patients across its drug candidates.
  • The company's third candidate, CF602, showed efficacy for erectile dysfunction.