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Final data from the AGENT study confirms topline results

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GOTHENBURG, Sweden, November 25, 2022 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced today that analysis of the AGENT study’s final data confirmed topline results presented on August 3, 2022. Moreover, no predictive gene expressions for clinical response could be identified. Isofol is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication. Isofol is in parallel continuing to investigate possible future paths forward for the company.

Isofol Medical AB (publ) appoints Jenny Sundqvist as Chief Commercial Officer

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GOTHENBURG, Sweden, December 10, 2021 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), today announced the appointment of Jenny Sundqvist as Chief Commercial Officer (CCO) as of January 1, 2022. Jenny is currently the Head of Commercial and Strategy Development at Isofol. Former CCO, Tony Gustavsson, leaves Isofol for a new international assignment in a global pharmaceutical group.

Isofol Medical AB (publ) invites to an audiocast on December 6 at 08.00 a.m. CET

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GOTHENBURG, Sweden, December 5, 2021 – Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), announced on December 3 that the ongoing phase III study AGENT will not reach 300 PFS events with current censoring rules based on FDA decision. Following this announcement, Isofol invites investors, analysts, and media to an audiocast (in English) with a Q&A-session on December 6, at 08:00 a.m. CET.

Isofol Medical AB (publ) will not reach 300 PFS events in the AGENT study with current censoring rules based on FDA decision

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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.

Isofol Medical AB (publ) receives FDA Fast Track Designation for arfolitixorin in advanced colorectal cancer (mCRC)

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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.

Isofol appoints nomination committee ahead of the Annual General Meeting 2022

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GOTHENBURG, Sweden, November 19, 2021 – Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), (”Isofol” or the ”Company”), announced today that the members of the nomination committee for the Annual General Meeting 2022 have been appointed in accordance with the principles for appointing nomination committees that were adopted at the Annual General Meeting on 23 June 2021.

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