Torsdag 5 Juni | 22:52:38 Europe / Stockholm

Prenumeration

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Est. tid*
2025-11-12 08:00 Kvartalsrapport 2025-Q3
2025-07-18 08:00 Kvartalsrapport 2025-Q2
2025-05-22 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2025-05-21 - Årsstämma
2025-05-21 - Kvartalsrapport 2025-Q1
2025-02-19 - Bokslutskommuniké 2024
2024-11-12 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-10 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2024-05-08 - Årsstämma
2024-05-08 - Kvartalsrapport 2024-Q1
2024-02-20 - Bokslutskommuniké 2023
2024-01-04 - Extra Bolagsstämma 2023
2023-11-10 - Kvartalsrapport 2023-Q3
2023-08-22 - Kvartalsrapport 2023-Q2
2023-05-04 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2023-05-03 - Årsstämma
2023-05-03 - Kvartalsrapport 2023-Q1
2023-02-23 - Bokslutskommuniké 2022
2023-02-13 - Extra Bolagsstämma 2022
2022-11-11 - Kvartalsrapport 2022-Q3
2022-08-23 - Kvartalsrapport 2022-Q2
2022-05-20 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2022-05-19 - Årsstämma
2022-05-12 - Kvartalsrapport 2022-Q1
2022-02-25 - Bokslutskommuniké 2021
2021-11-15 - Kvartalsrapport 2021-Q3
2021-08-24 - Kvartalsrapport 2021-Q2
2021-06-23 - Årsstämma
2021-05-21 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2021-05-20 - Kvartalsrapport 2021-Q1
2021-05-14 - Extra Bolagsstämma 2021
2021-02-26 - Bokslutskommuniké 2020
2020-11-13 - Kvartalsrapport 2020-Q3
2020-08-21 - Kvartalsrapport 2020-Q2
2020-06-25 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2020-06-24 - Årsstämma
2020-05-14 - Kvartalsrapport 2020-Q1
2020-05-05 - Extra Bolagsstämma 2020
2020-02-19 - Bokslutskommuniké 2019
2019-11-13 - Kvartalsrapport 2019-Q3
2019-08-22 - Kvartalsrapport 2019-Q2
2019-05-24 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2019-05-23 - Årsstämma
2019-05-23 - Kvartalsrapport 2019-Q1
2019-02-26 - Bokslutskommuniké 2018
2018-12-17 - Extra Bolagsstämma 2018
2018-11-14 - Kvartalsrapport 2018-Q3
2018-08-21 - Kvartalsrapport 2018-Q2
2018-05-16 - Kvartalsrapport 2018-Q1
2018-05-04 - X-dag ordinarie utdelning ISOFOL 0.00 SEK
2018-05-03 - Årsstämma
2018-02-20 - Bokslutskommuniké 2017
2017-11-20 - Kvartalsrapport 2017-Q3
2017-08-21 - Kvartalsrapport 2017-Q2
2017-05-16 - Årsstämma
2017-05-16 - Kvartalsrapport 2017-Q1

Beskrivning

LandSverige
ListaSmall Cap Stockholm
SektorHälsovård
IndustriBioteknik
Isofol Medical är ett forskningsbaserat bioteknikbolag som arbetar för att förbättra prognosen för patienter med svåra former av cancer. Bolagets läkemedelskandidat arfolitixorin syftar till att höja effekten av första linjens standardbehandling som globalt används vid flera former av solida tumörer. Isofol bedriver klinisk utveckling av arfolitixorin inom kolorektalcancer, världens tredje vanligaste cancerform, där det medicinska behovet av bättre behandlingar är stort.
2025-06-02 08:00:00

GOTHENBURG, Sweden, June 2, 2025 - Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces today that the company has been granted a Pre-IND meeting with the U.S. Food and Drug Administration (FDA) ahead of a planned Investigational New Drug (IND) application. An IND application aims to pave the way for clinical studies with arfolitixorin in the US.

The information in the press release is intended for investors.

Isofol is developing arfolitixorin to enhance the effectiveness of standard treatments given to patients with severe forms of cancer. The company is currently conducting a phase Ib/II clinical study in Germany in patients with metastatic colorectal cancer, aiming at evaluating the safety and tolerability of arfolitixorin at ascending doses, while also capturing indicationss of efficacy. In the second part of the study, where efficacy parameters will be the primary endpoints, an expansion of the study to additional countries is being planned.

The U.S. Food and Drug Administration (FDA), which is responsible for the approval of new treatments, has now granted Isofol’s request for a Pre-IND meeting ahead of a planned submission of an Investigational New Drug (IND) application. The dialogue with the FDA and the IND process aim to enable clinical development in the US.

“We are continuing to make progress in accordance with the development plan set up for arfolitixorin and are looking forward to paving the way for arfolitixorin on the important US market. It is particularly gratifying that the FDA grants a meeting instead of holding customary written correspondence,” says Petter Segelman Lindqvist, CEO at Isofol.

For more information, please contact
Isofol Medical AB (publ)
Petter Segelman Lindqvist, Chief Executive Officer 
E-mail: petter.s.lindqvist@isofolmedical.com
Phone: +46 (0) 739 60 12 56

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on June 2, 2025.

About Isofol Medical AB (publ)
Isofol Medical AB (publ) works to improve the quality of life and prognosis for patients with severe forms of cancer. The company's drug candidate arfolitixorin aims to increase the effect of first-line standard treatment for several forms of solid tumors and is currently being studied in colorectal cancer, the world's third most common cancer, where the medical need for better treatments is truly urgent. A phase Ib/II study is now being conducted with a new dosage regimen that are expected to optimize the effect of the drug candidate. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.
www.isofolmedical.com