FluoGuide updates IND submission timing for FG001 – trial initiation unaffected
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.