Isofol Medical AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the company's lead drug candidate arfolitixorin, the stabilized and biologically active pure form of folate ([6R]-MTHF), for treatment of patients with metastatic colorectal cancer (mCRC). The FDA's decision is based on the potential for arfolitixorin to address a large unmet medical need for new and more effective treatments of mCRC, the second deadly and third most common form of cancer. Fast Track Designation facilitates frequent communication with the FDA and can result in expedited review timelines and a potential early market authorization and approval to ensure that new treatments can be made available quicker for patients with serious diseases. As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study. The AGENT study is fully recruited and approximately 90 clinics in the United States, Canada, Europe, Australia and Japan have been involved in the study. The company?s ambition is to conclude the AGENT study in 2022 and thereafter apply for market approval with the FDA and EMA, which could result in a potential commercialization of arfolitixorin as early as 2023.