FluoGuide A/S

Bifogade filer

FluoGuide updates IND submission timing for FG001 – trial initiation unaffected

Kurs

-2,50%

Likviditet

0,22 MDKK

Prenumeration

Kalender

	Est. tid*
2026-11-26	07:20	Kvartalsrapport 2026-Q3
2026-08-25	07:20	Kvartalsrapport 2026-Q2
2026-05-27	07:20	Kvartalsrapport 2026-Q1
2026-03-25	N/A	Årsstämma
2026-02-25	07:00	Bokslutskommuniké 2025
2025-11-27	-	Kvartalsrapport 2025-Q3
2025-08-28	-	Kvartalsrapport 2025-Q2
2025-05-28	-	Kvartalsrapport 2025-Q1
2025-03-28	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2025-03-27	-	Årsstämma
2025-02-27	-	Bokslutskommuniké 2024
2024-11-27	-	Kvartalsrapport 2024-Q3
2024-08-29	-	Kvartalsrapport 2024-Q2
2024-05-30	-	Kvartalsrapport 2024-Q1
2024-03-21	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2024-03-20	-	Årsstämma
2024-02-28	-	Bokslutskommuniké 2023
2023-11-29	-	Kvartalsrapport 2023-Q3
2023-08-30	-	Kvartalsrapport 2023-Q2
2023-05-31	-	Kvartalsrapport 2023-Q1
2023-03-22	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2023-03-21	-	Årsstämma
2023-02-28	-	Bokslutskommuniké 2022
2022-11-24	-	Kvartalsrapport 2022-Q3
2022-08-25	-	Kvartalsrapport 2022-Q2
2022-05-31	-	Kvartalsrapport 2022-Q1
2022-05-19	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2022-05-18	-	Årsstämma
2022-03-30	-	Bokslutskommuniké 2021
2021-11-24	-	Kvartalsrapport 2021-Q3
2021-08-25	-	Kvartalsrapport 2021-Q2
2021-05-26	-	Kvartalsrapport 2021-Q1
2021-05-03	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2021-02-26	-	Bokslutskommuniké 2020
2021-02-09	-	Årsstämma
2020-11-20	-	Kvartalsrapport 2020-Q3
2020-08-14	-	Kvartalsrapport 2020-Q2
2020-05-27	-	Kvartalsrapport 2020-Q1
2020-04-09	-	X-dag ordinarie utdelning FLUO 0.00 DKK
2020-04-08	-	Årsstämma
2020-02-28	-	Bokslutskommuniké 2019
2019-11-29	-	Kvartalsrapport 2019-Q3
2019-05-31	-	Kvartalsrapport 2019-Q1

Beskrivning

Land	Danmark
Lista	First North Stockholm
Sektor	Hälsovård
Industri	Medicinteknik

FluoGuide är ett danskt bolag verksamt inom medicinteknik. Bolaget affärsfokus återfinns inom forskning och utveckling av behandlingar mot olika cancerformer, med störst fokus på utveckling av produkter som vägleder vid kirurgiska ingrepp. Produkterna binder till sig cancercellerna som då lyser upp och är avsedda att användas för att med precision kunna ta bort skadliga tumörer i patientens vävnad.

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FluoGuide updates IND submission timing for FG001 – trial initiation unaffected

2025-12-19 11:57:00

Copenhagen, Denmark, 19 December 2025 – FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company specializing in precision cancer surgery, today announced an update to the submission date for its for its Investigational New Drug (IND) application to mid-January 2026.

The updated timeline relates to the IND application supporting the first of two planned registration trials for FG001 in patients with high-grade glioma (HGG). The Company expects to submit the IND in mid-January 2026, compared to end-December 2025 as previously communicated.

Importantly, this updated submission timing will have no impact on the planned initiation of the first registration trial for FG001.

“I am thankful to our hard-working team and collaborating neurosurgeons for their focused efforts to complete the IND application, which is designed to guide surgery in patients with high-grade glioma,” said Morten Albrechtsen, CEO of FluoGuide.

About FluoGuide
FluoGuide lights up cancer to maximize surgical outcomes in oncology. FluoGuide’s lead product, FG001, is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit – it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. Ultimately, the improved precision enhances the likelihood of complete cure and lower healthcare costs. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer. FluoGuide has entered partnerships with leading MedTech companies with the aim of accelerating development and commercialization. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”.

For more information on FG001 or FluoGuide’s uPAR technology platform, please visit our home page www.fluoguide.com

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FluoGuide A/S

Bifogade filer

Kurs -2,50%

Likviditet 0,22 MDKK