Author name: Admin Isofol

GOTHENBURG, Sweden, December 3, 2021 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today that the U.S. Food and Drug Administration (FDA) denied a request from the company to adjust the analysis of the pivotal AGENT study’s secondary endpoint of progression-free survival (PFS). However, the decision will not affect the study’s primary endpoint, objective response rate, previously agreed upon with the FDA. The secondary endpoint may have to be somewhat modified.

GOTHENBURG, Sweden, November 23, 2021 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today 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 deadliest 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 earlier market authorization and approval to ensure that new treatments can be made available quicker for patients with serious diseases.