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.
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.
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.
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.
GOTHENBURG, Sweden, November 11, 2021 – Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announced today that the company’s interim report for January – September 2021 is now available on the company’s website, www.isofolmedical.com.
GOTHENBURG, Sweden, October 21, 2021 – Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), (”Isofol” or the ”Company”), announced today that the Company’s shares are admitted to trading on Nasdaq Stockholm.
GOTHENBURG, Sweden, October 18, 2021 – Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), (“Isofol” or the “Company”), announced today that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.
GOTHENBURG, Sweden, October 15, 2021 – Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), (“Isofol” or the “Company”), announced today that the Company intends to list its shares on Nasdaq Stockholm. Isofol’s shares are currently traded on Nasdaq First North Premier Growth Market under the ticker ISOFOL.
From September 7-17 Isofol participated in LSX Nordic Congress, an opportunity for 1:1 meetings with Nordic life science executives focused on International Strategy, Investment, Partnering and Deal Making. See Isofol´s CEO, Jarl Ulf Jungnelius’ company presentation from the event below.
