Benzinga | Apr 20, 2021 07:05AM EDT

Can-Fite Initiates Preclinical Studies Required by FDA and EMA for the Registration of its Two Lead Drug Candidates

Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, announced today that in preparation for anticipated potential marketing registration filings for its drug candidates Piclidenoson and Namodenoson in the U.S. and Europe, the Company has initiated a series of preclinical studies required by regulators.

As part of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), both regulators require certain preclinical data be submitted along with the pivotal Phase III data.