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Isofol Medical — Investor Relations & Filings

Ticker · ISOFOL ISIN · SE0009581051 LEI · 549300MCXYAHG7VBHX75 ST Professional, scientific and technical activities
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Filings indexed 208 across all filing types
Latest filing 2022-02-24 Regulatory Filings
Country SE Sweden
Listing ST ISOFOL

About Isofol Medical

https://isofolmedical.com/

Isofol Medical is a clinical-stage biotechnology company dedicated to improving treatments for severe forms of cancer. The company's primary focus is the development of its lead drug candidate, arfolitixorin. This next-generation, folate-based therapy is designed to enhance the efficacy of standard cancer treatments, such as chemotherapy. Arfolitixorin is the active metabolite of commonly used folate-based drugs, potentially offering a therapeutic benefit to a broader patient population by bypassing complex metabolic activation steps. The company's goal is to help more patients respond better to their treatment, thereby improving their prognosis.

Recent filings

Filing Released Lang Actions
Regulatory Filings 2022
Regulatory Filings Classification · 95% confidence The document is a navigation page for the Swedish Financial Supervisory Authority (Finansinspektionen) portal for stock market information. It contains links for searching, reporting, and flagging, but does not contain any specific financial data, corporate reports, or regulatory announcements. As it is a general portal interface and does not fit into any specific category, it is classified as a general regulatory filing.
2022-02-24 English
Interim / Quarterly Report 2021
Interim / Quarterly Report Classification · 100% confidence The document is titled 'BOKSLUTSKOMMUNIKÉ 2021' (Year-End Report 2021) for Isofol Medical AB. It contains comprehensive financial statements, including income statements, balance sheet data, and key performance indicators for the fourth quarter and the full year 2021. It also includes management commentary, operational updates, and forward-looking statements. This fits the definition of an Interim/Quarterly Report (IR) as it provides substantive financial data and analysis for a period shorter than a full fiscal year (or in this case, the year-end report which functions as the final quarterly report). Q4 2021
2022-02-24 Swedish
Interim / Quarterly Report 2021
Interim / Quarterly Report Classification · 100% confidence The document is titled 'ISOFOL MEDICAL AB (PUBL) YEAR-END REPORT 2021'. It contains comprehensive financial statements, key figures for the fourth quarter and full year 2021, management commentary, and operational updates. It is a formal financial report covering a period shorter than a full fiscal year (in this case, the year-end report which functions as the final quarterly/interim report for the fiscal year). It meets the criteria for an Interim/Quarterly Report (IR) as it provides substantive financial data and analysis. Q4 2021
2022-02-24 English
Isofol Medical AB (publ) will not reach 300 PFS events in the AGENT study with current censoring rules based on FDA decision
Regulatory Filings Classification · 95% confidence The document is a press release from Isofol Medical AB dated December 3, 2021, announcing an update regarding the FDA's decision on censoring rules for the AGENT study and the resulting inability to reach the target of 300 Progression-Free Survival (PFS) events. This type of announcement, detailing operational updates, regulatory interactions, and potential impacts on study timelines, is characteristic of an announcement intended for investors and the market. It is not a full financial report (10-K or IR), a transcript (CT), or a formal proxy/remuneration document (DEF 14A). Since it is a specific, material announcement concerning clinical trial progress and regulatory feedback, it fits best under the general category of Regulatory Filings (RNS) as a broad market disclosure, or potentially an Investor Presentation (IP) if it were a slide deck, but given the format and content (a press release about a regulatory interaction and study status), RNS serves as the most appropriate catch-all for significant, non-standardized corporate news that impacts valuation, especially as it mentions being made public pursuant to the EU Market Abuse Regulation. Given the options, RNS is the best fit for a material, non-financial regulatory update press release.
2021-12-03 English
Isofol Medical AB (publ) når inte 300 PFS-händelser i AGENT-studien med nuvarande censureringsregler baserat på FDA-beslut
Regulatory Filings Classification · 95% confidence The document is a press release dated December 3, 2021, from Isofol Medical AB concerning an update on their pivotal AGENT clinical study, specifically regarding the FDA's decision on adjusting the analysis of the secondary endpoint (PFS events). It discusses clinical trial progress, regulatory feedback (FDA Type C meeting), potential delays, and future expectations for results. This type of announcement, detailing operational and clinical trial updates that impact financial outlook but are not the full financial report (10-K/IR) or a formal earnings release (ER), most closely aligns with a general corporate update or regulatory communication. Since it is a detailed update on a significant business/clinical matter, it is best classified as a Regulatory Filing (RNS) as a general announcement, or potentially an Investor Presentation (IP) if it were structured as a slide deck, but given the format, RNS is the most appropriate catch-all for significant, non-standardized corporate news that isn't explicitly covered by other codes like DIV, DIRS, or ER. It is not a formal financial report (10-K, IR) nor a simple announcement of a report (RPA).
2021-12-03 Swedish
Isofol Medical AB (publ) receives FDA Fast Track Designation for arfolitixorin in advanced colorectal cancer (mCRC)
Regulatory Filings Classification · 95% confidence The document is an announcement from Isofol Medical AB regarding receiving Fast Track Designation from the FDA for their drug candidate arfolitixorin. It details the significance of this designation, quotes the CEO, and mentions upcoming clinical milestones (AGENT study results in H1 2022). The text concludes with a statement indicating it is information the company is obliged to make public pursuant to the EU Market Abuse Regulation, suggesting it is a formal regulatory disclosure. Since it is a specific announcement about regulatory progress (FDA designation) and not a full financial report (10-K, IR), nor a general earnings release (ER), nor a proxy statement (DEF 14A), it fits best under the general 'Regulatory Filings' category (RNS) as a significant, non-financial regulatory event announcement, or potentially a general 'LTR' if viewed as a regulatory action, but RNS is the broader catch-all for such specific regulatory news not covered elsewhere. Given the nature of the announcement (FDA designation), RNS is the most appropriate fit for a specific regulatory update that isn't a standard financial filing.
2021-11-23 English

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